Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With a Sulfonylurea in Subjects With Type 2 Diabetes
Verified date | February 2012 |
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 efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.
Status | Completed |
Enrollment | 500 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria - Diagnosis of type 2 diabetes mellitus , currently treated with a sulfonylurea alone but experiencing inadequate glycemic control. Should have received the sulfonylurea monotherapy for at least the 3 months prior to Screening; has been on a stable sulfonylurea dose equivalent to at least 10 mg of glyburide (Exception: documented maximum tolerated dose equivalent to less than 10 mg but at least 5 mg glyburide) for at least 8 weeks. - No treatment with antidiabetic agents other than a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.) - Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2. - Fasting C-peptide concentration greater than or equal to 0.8 ng/mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng/mL after a challenge test.). - Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive. - If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator. - Systolic blood pressure less than or equal to180 mm Hg and diastolic pressure less than or equal to 110 mm Hg - Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to 10 g per dL for females - Alanine aminotransferase less than or equal to 3 time the upper limit of normal. - Serum creatinine =2.0 mg/dL (=17 micromol/L) - Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid. - Neither pregnant nor lactating - Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in 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 prohibits the subject from completing the study. - Able and willing to provide written informed consent Exclusion Criteria - Urine albumin to creatinine ratio of greater than 1000 µg per mg at Screening. If elevated, the subject may be rescreened within 1 week. - History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.) - History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. - History of treated diabetic gastric paresis. - New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study. - History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening. - History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin. - History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. - History of a psychiatric disorder that will affect the subject's ability to participate in the study. - History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors. - History of alcohol or substance abuse within the 2 years prior to Screening. - Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening. - Prior treatment in an investigational study of alogliptin. - Excluded Medications and Treatments: - Treatment with antidiabetic agents other than study drug or glyburide is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures. - Treatment with weight-loss drugs, any investigational antidiabetics, Bosentan (used for the treatment of pulmonary hypertension), or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of- treatment/early termination procedures. Inhaled corticosteroids are allowed. - Subjects must not take any medications, including over-the-counter products, without first consulting with the investigator. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda |
United States, Argentina, Australia, Brazil, Chile, Dominican Republic, Guatemala, India, Mexico, Netherlands, New Zealand, Peru, Poland, South Africa, United Kingdom,
Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q; Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab. — View Citation
Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline. | Baseline and Week 26. | No |
Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 4). | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline. | Baseline and Week 4. | No |
Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 8). | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline. | Baseline and Week 8. | No |
Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 12). | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline. | Baseline and Week 12. | No |
Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 16). | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline. | Baseline and Week 16. | No |
Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 20). | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline. | Baseline and Week 20. | No |
Secondary | Change From Baseline in Fasting Plasma Glucose (Week 1). | The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline. | Baseline and Week 1. | No |
Secondary | Change From Baseline in Fasting Plasma Glucose (Week 2). | The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. | Baseline and Week 2. | No |
Secondary | Change From Baseline in Fasting Plasma Glucose (Week 4). | The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. | Baseline and Week 4. | No |
Secondary | Change From Baseline in Fasting Plasma Glucose (Week 8). | The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. | Baseline and Week 8. | No |
Secondary | Change From Baseline in Fasting Plasma Glucose (Week 12). | The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. | Baseline and Week 12. | No |
Secondary | Change From Baseline in Fasting Plasma Glucose (Week 16). | The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. | Baseline and Week 16. | No |
Secondary | Change From Baseline in Fasting Plasma Glucose (Week 20). | The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. | Baseline and Week 20. | No |
Secondary | Change From Baseline in Fasting Plasma Glucose (Week 26). | The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline. | Baseline and Week 26. | No |
Secondary | Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose = 200 mg Per dL). | The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study. | 26 Weeks. | No |
Secondary | Number of Participants Requiring Rescue. | The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study. | 26 Weeks. | No |
Secondary | Change From Baseline in Fasting Proinsulin (Week 4). | The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline. | Baseline and Week 4. | No |
Secondary | Change From Baseline in Fasting Proinsulin (Week 8). | The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline. | Baseline and Week 8. | No |
Secondary | Change From Baseline in Fasting Proinsulin (Week 12). | The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline. | Baseline and Week 12. | No |
Secondary | Change From Baseline in Fasting Proinsulin (Week 16). | The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline. | Baseline and Week 16. | No |
Secondary | Change From Baseline in Fasting Proinsulin (Week 20). | The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline. | Baseline and Week 20. | No |
Secondary | Change From Baseline in Fasting Proinsulin (Week 26). | The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline. | Baseline and Week 26. | No |
Secondary | Change From Baseline in Insulin (Week 4). | The change between the value of insulin collected at week 4 and insulin collected at baseline. | Baseline and Week 4. | No |
Secondary | Change From Baseline in Insulin (Week 8). | The change between the value of insulin collected at week 8 and insulin collected at baseline. | Baseline and Week 8. | No |
Secondary | Change From Baseline in Insulin (Week 12). | The change between the value of insulin collected at week 12 and insulin collected at baseline. | Baseline and Week 12. | No |
Secondary | Change From Baseline in Insulin (Week 16). | The change between the value of insulin collected at week 16 and insulin collected at baseline. | Baseline and Week 16. | No |
Secondary | Change From Baseline in Insulin (Week 20). | The change between the value of insulin collected at week 20 and insulin collected at baseline. | Baseline and Week 20. | No |
Secondary | Change From Baseline in Insulin (Week 26). | The change between the value of insulin collected at week 26 and insulin collected at baseline. | Baseline and Week 26. | No |
Secondary | Change From Baseline in Proinsulin/Insulin Ratio (Week 4). | The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline. | Baseline and Week 4. | No |
Secondary | Change From Baseline in Proinsulin/Insulin Ratio (Week 8). | The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline. | Baseline and Week 8. | No |
Secondary | Change From Baseline in Proinsulin/Insulin Ratio (Week 12). | The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline. | Baseline and Week 12. | No |
Secondary | Change From Baseline in Proinsulin/Insulin Ratio (Week 16). | The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline. | Baseline and Week 16. | No |
Secondary | Change From Baseline in Proinsulin/Insulin Ratio (Week 20). | The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline. | Baseline and Week 20. | No |
Secondary | Change From Baseline in Proinsulin/Insulin Ratio (Week 26). | The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline. | Baseline and Week 26. | No |
Secondary | Change From Baseline in C-peptide (Week 4). | The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline. | Baseline and Week 4. | No |
Secondary | Change From Baseline in C-peptide (Week 8). | The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline. | Baseline and Week 8. | No |
Secondary | Change From Baseline in C-peptide (Week 12). | The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline. | Baseline and Week 12. | No |
Secondary | Change From Baseline in C-peptide (Week 16). | The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline. | Baseline and Week 16. | No |
Secondary | Change From Baseline in C-peptide (Week 20). | The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline. | Baseline and Week 20. | No |
Secondary | Change From Baseline in C-peptide (Week 26). | The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline. | Baseline and Week 26. | No |
Secondary | Number of Participants With Glycosylated Hemoglobin = 6.5%. | The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study. | Baseline and Week 26. | No |
Secondary | Number of Participants With Glycosylated Hemoglobin = 7.0%. | The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study. | Baseline and Week 26. | No |
Secondary | Number of Participants With Glycosylated Hemoglobin = 7.5%. | The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study. | Baseline and Week 26. | No |
Secondary | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 0.5%. | The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study. | Baseline and Week 26. | No |
Secondary | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 1.0%. | The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study. | Baseline and Week 26. | No |
Secondary | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 1.5%. | The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study. | Baseline and Week 26. | No |
Secondary | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 2.0%. | The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study. | Baseline and Week 26. | No |
Secondary | Change From Baseline in Body Weight (Week 8). | The change between Body Weight measured at week 8 and Body Weight measured at baseline. | Baseline and Week 8. | No |
Secondary | Change From Baseline in Body Weight (Week 12). | The change between Body Weight measured at week 12 and Body Weight measured at baseline. | Baseline and Week 12. | No |
Secondary | Change From Baseline in Body Weight (Week 20). | The change between Body Weight measured at week 20 and Body Weight measured at baseline. | Baseline and Week 20. | No |
Secondary | Change From Baseline in Body Weight (Week 26). | The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline. | Baseline and Week 26. | No |
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