Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

Official Title: “A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy”

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Intervention(s) in this Clinical Trial

• Drug: BI 1356
  • 5mg TID in the morning for 104 weeks
• Drug: Glimepiride
  • 1-4mg TID in the morning for 104 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: BI 1356 5mg TID
  • patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride
• Active Comparator: Glimepiride
  • patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)

Primary Measures

• The primary endpoint in this study is the change from baseline in HbA1c (HbA1c after 104 weeks).
  • Time Frame: 104 weeks
    Safety Issue?: No

Secondary Measures

• Key secondary endpoint for regulatory purpose is the change from baseline in HbA1c after 52 wks of treatment. Change from baseline in FPG after 52 and 104 weeks of treatment
  • Time Frame: 104 weeks
    Safety Issue?: No

Inclusion criteria

• 1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
• 2. HbA1c 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
• 3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
• 4. HbA1c 6.5 10.0% at beginning of the placebo run-in phase

Exclusion criteria

• 1. Myocardial infarction, stroke or TIA
• 2. Impaired hepatic function
• 3. Renal failure or renal impairment
• 4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
• 5. Treatment with insulin or GLP-1 analogue/antagonists within 3 months prior to screening

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 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/NCT00622284

Study ID Number: 1218.20

ClinicalTrials.gov Identifier: NCT00622284

Health Authority: Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia