Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.
| Status | Completed |
| Enrollment | 278 |
| Est. completion date | |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 79 Years |
| Eligibility |
Inclusion criteria: 1. Diagnosis of diabetes mellitus prior to informed consent 2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks) 3. Glycosylated haemoglobin A1 >= 7.5% and <= 10% 4. Age between 18 and less than 80 5. - Body Mass index less or equal to 45 Exclusion criteria: 1. Uncontrolled hyperglycaemia during run in period 2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent 3. Impaired hepatic function 4. Gastric by pass surgery 5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent 6. Treatment with anti-obesity drugs 7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent 8. Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | 1218.61.3301A Boehringer Ingelheim Investigational Site | Besancon | |
| France | 1218.61.3306A Boehringer Ingelheim Investigational Site | Beziers | |
| France | 1218.61.3311A Boehringer Ingelheim Investigational Site | Beziers | |
| France | 1218.61.3309A Boehringer Ingelheim Investigational Site | Bourg des cptes | |
| France | 1218.61.3310A Boehringer Ingelheim Investigational Site | Cournonterral | |
| France | 1218.61.3312A Boehringer Ingelheim Investigational Site | Laval | |
| France | 1218.61.3313A Boehringer Ingelheim Investigational Site | Louvigne De bais | |
| France | 1218.61.3305A Boehringer Ingelheim Investigational Site | Paris | |
| France | 1218.61.3307A Boehringer Ingelheim Investigational Site | Paris | |
| India | 1218.61.91002 Boehringer Ingelheim Investigational Site | Bangalore | |
| India | 1218.61.91003 Boehringer Ingelheim Investigational Site | Bangalore | |
| India | 1218.61.91004 Boehringer Ingelheim Investigational Site | Bangalore | |
| India | 1218.61.91008 Boehringer Ingelheim Investigational Site | Hyderabad | |
| India | 1218.61.91009 Boehringer Ingelheim Investigational Site | Jaipur | |
| India | 1218.61.91010 Boehringer Ingelheim Investigational Site | Karnataka | |
| India | 1218.61.91001 Boehringer Ingelheim Investigational Site | Maharashtra | |
| India | 1218.61.91006 Boehringer Ingelheim Investigational Site | Maharashtra | |
| India | 1218.61.91011 Boehringer Ingelheim Investigational Site | Maharashtra | |
| India | 1218.61.91005 Boehringer Ingelheim Investigational Site | Mumbai | |
| India | 1218.61.91007 Boehringer Ingelheim Investigational Site | Mumbai | |
| Philippines | 1218.61.63003 Boehringer Ingelheim Investigational Site | Cebu City | |
| Philippines | 1218.61.63004 Boehringer Ingelheim Investigational Site | Cebu City | |
| Philippines | 1218.61.63002 Boehringer Ingelheim Investigational Site | Davao City | |
| United States | 1218.61.01001 Boehringer Ingelheim Investigational Site | Auburn | Maine |
| United States | 1218.61.01024 Boehringer Ingelheim Investigational Site | Bennington | Vermont |
| United States | 1218.61.01016 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1218.61.01018 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1218.61.01005 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1218.61.01031 Boehringer Ingelheim Investigational Site | East Providence | Rhode Island |
| United States | 1218.61.01028 Boehringer Ingelheim Investigational Site | Escondido | California |
| United States | 1218.61.01014 Boehringer Ingelheim Investigational Site | Greenbrae | California |
| United States | 1218.61.01007 Boehringer Ingelheim Investigational Site | Greensboro | North Carolina |
| United States | 1218.61.01006 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1218.61.01004 Boehringer Ingelheim Investigational Site | Jacksonville | North Carolina |
| United States | 1218.61.01048 Boehringer Ingelheim Investigational Site | Lafayette | Indiana |
| United States | 1218.61.01052 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada |
| United States | 1218.61.01049 Boehringer Ingelheim Investigational Site | Lawrenceville | Georgia |
| United States | 1218.61.01015 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1218.61.01040 Boehringer Ingelheim Investigational Site | Meridian | Idaho |
| United States | 1218.61.01009 Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | 1218.61.01030 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1218.61.01043 Boehringer Ingelheim Investigational Site | Olive Branch | Mississippi |
| United States | 1218.61.01042 Boehringer Ingelheim Investigational Site | Paramount | California |
| United States | 1218.61.01027 Boehringer Ingelheim Investigational Site | Perrysburg | Ohio |
| United States | 1218.61.01046 Boehringer Ingelheim Investigational Site | Poway | California |
| United States | 1218.61.01008 Boehringer Ingelheim Investigational Site | Roswell | Georgia |
| United States | 1218.61.01053 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1218.61.01044 Boehringer Ingelheim Investigational Site | San Diego | California |
| United States | 1218.61.01017 Boehringer Ingelheim Investigational Site | Simpsonville | South Carolina |
| United States | 1218.61.01020 Boehringer Ingelheim Investigational Site | Spokane | Washington |
| United States | 1218.61.01003 Boehringer Ingelheim Investigational Site | Sugar Land | Texas |
| United States | 1218.61.01023 Boehringer Ingelheim Investigational Site | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim | Eli Lilly and Company |
United States, France, India, Philippines,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 24 weeks | No |
| Secondary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 6 weeks | No |
| Secondary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 12 weeks | No |
| Secondary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 18 weeks | No |
| Secondary | Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | 24 weeks | No |
| Secondary | Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | 24 weeks | No |
| Secondary | Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | 24 weeks | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24 | baseline, 24 weeks | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6 | baseline, 6 weeks | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12 | baseline, 12 weeks | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks | Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18 | baseline, 18 weeks | No |
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