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 (1 to 4 mg Once Daily ) 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

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2010

Intervention(s) in this Clinical Trial

• Drug: BI 1356
• Drug: Glimepiride

Primary Measures

• The primary endpoint in this study is the change from baseline in HbA1c (HbA1c after 104 weeks).
  • Time Frame: 104 weeks
    

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
    

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. reatment 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 Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

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