Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322) and Pioglitazone HCl (ACTOS®), in Subjects With Type 2 Diabetes
Verified date | February 2013 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.
Status | Completed |
Enrollment | 1554 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Men or women with a historical diagnosis of type 2 diabetes mellitus who were treated with metformin greater than or equal to 1500 mg alone but were experiencing inadequate glycemic control. - A stable dose of metformin of greater than or equal to 1500 mg or maximum tolerated dose. - No treatment with antidiabetic agents other than metformin within the 2 months prior to Screening. - A body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^2. - Fasting C-peptide greater than or equal to 0.8 ng/mL. - Regular use of other, non-excluded medications was allowed if a stable dose had been established for at least 4 weeks prior to Screening. - Systolic blood pressure less than or equal to 160 mmHg and diastolic pressure less than or equal to 100 mmHg. - Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women. - Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal. - Serum creatinine less than 1.5 mg/dL for men and less than 1.4 mg/dL for women. - Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject was clinically euthyroid. - Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. - Able and willing to monitor their own blood glucose concentrations with a home glucose monitor. - No major illness or debility that in the investigator's opinion prohibited the patient from completing the study. Exclusion Criteria: - Urine albumin/creatinine ratio greater than 113 mg/mmol at Screening. - A history of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 5 years prior to Screening. - A history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening. - A history of treated diabetic gastroparesis. - New York Heart Association Class III or IV heart failure regardless of therapy. - History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening. - History of any hemoglobinopathy. - History of infection with hepatitis B, hepatitis C or human immunodeficiency virus. - History of a psychiatric disorder that could have affected the patient's ability to participate in the study. - History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors. - A history of alcohol or substance abuse within 2 years prior to Screening. - Receipt of any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening. - Previous participation in an investigational study of alogliptin. - Hypersensitive to pioglitazone, alogliptin, or other excipients. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda |
United States, Australia, Brazil, Bulgaria, Chile, Croatia, Estonia, Guatemala, India, Israel, Latvia, Mexico, New Zealand, Peru, Romania, Russian Federation, Serbia, South Africa, Ukraine,
DeFronzo RA, Burant CF, Fleck P, Wilson C, Mekki Q, Pratley RE. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 May;97(5):1615-22. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis) | The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone). |
Baseline and Week 26 | No |
Primary | Change From Baseline to Week 26 in HbA1c | The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). | Baseline and Week 26 | No |
Secondary | Change From Baseline in HbA1c Over Time (Grouped Analysis) | The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates. |
Baseline and Weeks 4, 8, 12, 16 and 20. | No |
Secondary | Change From Baseline to Week 4 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. | Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in HbA1c | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. |
Baseline and Week 20 | No |
Secondary | Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis) | The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. |
Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26. | No |
Secondary | Change From Baseline to Week 1 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 1 | No |
Secondary | Change From Baseline to Week 2 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 2 | No |
Secondary | Change From Baseline to Week 4 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in Fasting Plasma Glucose | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. | Baseline and Week 26 | No |
Secondary | Percentage of Participants With Marked Hyperglycemia (Grouped Analysis) | Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L). This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. |
From Week 1 to Week 26 | No |
Secondary | Percentage of Participants With Marked Hyperglycemia | Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L). | From Week 1 to Week 26 | No |
Secondary | Percentage of Participants Meeting Rescue Criteria (Grouped Analysis) | Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory: After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose =300 mg/dL; From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose =275 mg/dL; From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose =250 mg/dL; From the Week 12 Visit through the End-of-Treatment Visit: HbA1c =8.5% and =0.5% reduction in HbA1c as compared with Baseline HbA1c. |
From Week 1 to Week 26. | No |
Secondary | Percentage of Participants Meeting Rescue Criteria | Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory: After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose =300 mg/dL; From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose =275 mg/dL; From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose =250 mg/dL; From the Week 12 Visit through the End-of-Treatment Visit: HbA1c =8.5% and =0.5% reduction in HbA1c as compared with Baseline HbA1c. |
From Week 1 to Week 26 | No |
Secondary | Percentage of Participants With Glycosylated Hemoglobin = 6.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. |
Week 26 | No |
Secondary | Percentage of Participants With Glycosylated Hemoglobin = 6.5% | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%. | Week 26 | No |
Secondary | Percentage of Participants With Glycosylated Hemoglobin = 7.0% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. |
Week 26 | No |
Secondary | Percentage of Participants With Glycosylated Hemoglobin = 7% | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%. | Week 26 | No |
Secondary | Percentage of Participants With Glycosylated Hemoglobin = 7.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. |
Week 26 | No |
Secondary | Percentage of Participants With Glycosylated Hemoglobin = 7.5% | Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%. | Week 26 | No |
Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 0.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. |
Baseline and Week 26 | No |
Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 0.5% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%. | Baseline and Week 26 | No |
Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. |
Baseline and Week 26 | No |
Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%. | Baseline and Week 26 | No |
Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1.5% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. |
Baseline and Week 26 | No |
Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1.5% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%. | Baseline and Week 26 | No |
Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 2.0% (Grouped Analysis) | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. |
Baseline and Week 26. | No |
Secondary | Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 2% | Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2%. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis) | Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and proinsulin as continuous covariates. |
Baseline and Weeks 4, 8, 12, 16, 20 and 26. | No |
Secondary | Change From Baseline to Week 4 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in Fasting Proinsulin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Insulin Over Time (Grouped Analysis) | The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. | No |
Secondary | Change From Baseline to Week 4 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in Insulin Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis) | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. |
Baseline and Weeks 4, 8, 12, 16, 20 and 26. | No |
Secondary | Change From Baseline to Week 4 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. |
Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. |
Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. |
Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. |
Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in Proinsulin/Insulin Ratio | The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL). Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in C-peptide Over Time (Grouped Analysis) | C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. |
Baseline and Weeks 4, 8, 12, 16, 20 and 26. | No |
Secondary | Change From Baseline to Week 4 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in C-peptide Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Total Cholesterol Over Time (Grouped Analysis) | Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. | No |
Secondary | Change From Baseline to Week 4 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in Total Cholesterol Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis) | Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. |
Baseline and Weeks 4, 8, 12, 16, 20 and 26. | No |
Secondary | Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis) | Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. |
Baseline and Weeks 4, 8, 12, 16, 20 and 26. | No |
Secondary | Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Triglycerides Over Time (Grouped Analysis) | Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Weeks 4, 8, 12, 16, 20 and 26. | No |
Secondary | Change From Baseline to Week 4 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 4 | No |
Secondary | Change From Baseline to Week 8 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 16 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 16 | No |
Secondary | Change From Baseline to Week 20 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in Triglyceride Levels | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis) | Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. | Baseline and Weeks 12 and 26. | No |
Secondary | Change From Baseline to Week 12 in Free Fatty Acids | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Free Fatty Acids | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis) | Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. |
Baseline and Weeks 12 and 26. | No |
Secondary | Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis) | Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. |
Baseline and Weeks 12 and 26. | No |
Secondary | Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Adiponectin Over Time (Grouped Analysis) | Change from Baseline in adiponectin was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. | Baseline and Weeks 12 and 26. | No |
Secondary | Change From Baseline to Week 12 in Adiponectin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Adiponectin | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Body Weight Over Time (Grouped Analysis) | Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Weeks 8, 12, 20 and 26. | No |
Secondary | Change From Baseline to Week 8 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Week 8 | No |
Secondary | Change From Baseline to Week 12 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 20 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Week 20 | No |
Secondary | Change From Baseline to Week 26 in Body Weight | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis) | HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater insulin resistance. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates. |
Baseline and Weeks 12 and 26. | No |
Secondary | Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance | The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance | The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis) | The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates. |
Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function | The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population. HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function | The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population. HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis) | Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. | Baseline and Weeks 12 and 26. | No |
Secondary | Change From Baseline to Week 12 in Apolipoprotein A1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Apolipoprotein A1 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis) | Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. | Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in Apolipoprotein A2 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Apolipoprotein A2 | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis) | Change from Baseline in Apolipoprotein B was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. | Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in Apolipoprotein B | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Apolipoprotein B | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis) | Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. | Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in Apolipoprotein C-III | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Apolipoprotein C-III | Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis) | Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates. |
Baseline and Weeks 12 and 26. | No |
Secondary | Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides | NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 12. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides | NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis) | The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates. |
Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in VLDL / Chylomicron Particles | The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in VLDL / Chylomicron Particles | The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis) | The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. |
Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides | The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides | The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. | Baseline and Week 26 | No |
Secondary | Change From Baseline in VLDL Particles Over Time (Grouped Analysis) | The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates. |
Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in VLDL Particles | The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in VLDL Particles | The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates |
Baseline and Week 26 | No |
Secondary | Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis) | The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates. |
Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in Mean VLDL Particle Size | The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Mean VLDL Particle Size | The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis) | The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates. |
Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in IDL Particles | The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in IDL Particles | The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis) | The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates. |
Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in LDL Particles | The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in LDL Particles | The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis) | The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates. |
Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in Mean LDL Particle Size | The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Mean LDL Particle Size | The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis) | The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates. |
Baseline and Weeks 12 and 26. | No |
Secondary | Change From Baseline to Week 12 in HDL Particles | The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates. |
Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in HDL Particles | The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates. |
Baseline and Week 26 | No |
Secondary | Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis) | The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. |
Baseline and Weeks 12 and 26 | No |
Secondary | Change From Baseline to Week 12 in Mean HDL Particle Size | The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. | Baseline and Week 12 | No |
Secondary | Change From Baseline to Week 26 in Mean HDL Particle Size | The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. | Baseline and Week 26 | No |
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