Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

Official Title: “A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.”

The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1 356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metfor min in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In additi on, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for com parison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability a nd efficacy of BI 1356 BS will also be tested in this study.

Intervention(s) in this Clinical Trial

• Drug: Linagliptin
  • Linagliptin medium dose tablet once daily
• Drug: Linagliptin
  • Linagliptin high dose tablet once daily
• Drug: Linagliptin
  • Linagliptin low dose tablet once daily
• Drug: Placebo
  • Placebo tablets once daily
• Drug: Glimepiride
  • Glimepiride tablets once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Linagliptin low dose
  • Patients receive Linagliptin low dose tablets once daily
• Experimental: Linagliptin medium dose
  • Patients receive Linagliptin medium dose tablets once daily
• Experimental: Linagliptin high dose
  • Patients receive Linagliptin high dose tablets once daily
• Placebo Comparator: Placebo
  • Patients receive tablets identical to those containing Linagliptin low, medium and high dose
• Active Comparator: Glimepiride
  • Patients receive Glimepiride tablets once daily

Primary Measures

• HbA1c Change From Baseline at Week 12
  • Time Frame: Baseline and week 12
    Safety Issue?: No

Secondary Measures

• Percentage of Patients With HbA1c<=7.0% at Week 12
  • Time Frame: week 12
    Safety Issue?: No
• Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12
  • Time Frame: Baseline and week 12
    Safety Issue?: No

Inclusion criteria:

Inclusion_Criteria:

• Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
• HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
• HbA1c 7.5 10.0% at screening for patients treated with metformin alone
• HbA1c 7.5 10.0% at beginning of the placebo run-in phase
• Age > 21 and < 75 years
• MI > 25 and < 40 kg/m2 (Body Mass Index)

Exclusion criteria:

Exclusion_Criteria:

• Clinically relevant cardiovascular disease
• Impaired hepatic function
• Renal insufficiency or impaired renal function
• Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
• Treatment with insulin within 3 months prior to screening

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00309608

Study ID Number: 1218.6

ClinicalTrials.gov Identifier: NCT00309608

Health Authority: France: AFSSAPS