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 t”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

This randomised, double-blind, and placebo-controlled, five parallel groups study compares 3 doses of BI 1356 BS to placebo as add-on therapy to metformin. In addition, there will be an open-label treatment arm with glimepiride. Patients with type 2 diabetes who meet the entry criteria are planned for inclusion in this trial. The randomised treatment will be double-blind within the dose groups of BI 1356 BS and placebo (i.e. each patient will receive one active treatment and two placebos matching the alternative active treatment, or three placebos, respectively).

Up to 500 patients will be enrolled into the trial in 5 countries to ensure that 375 patients are randomised to trial treatment (75 to each treatment group) and complete the trial.

Study Hypothesis:

The superiority of treatment with BI 1356 BS to placebo will be tested by the comparison of HbA1c change from baseline.

Comparison(s):

Placebo Glimepiride

Intervention(s) in this Clinical Trial

• Drug: BI 1356 BS
• Drug: Glimepiride

Primary Measures

• The primary endpoint in this study is the change of HbA1c from baseline to week 12.

Secondary Measures

• The secondary endpoints are the change of fasting plasma glucose after 12 weeks of treatment compared to baseline and the occurrence of an absolute efficacy response, that is an HbA1c under treatment of <= 7.0%

Inclusion_Criteria:

• 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
• 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
• BMI > 25 and < 40 kg/m2 (Body Mass Index)

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 Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair B.I. Pharma GmbH & Co. KG  

Information obtained from ClinicalTrials.gov on August 28, 2008

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

Study ID Number: 1218.6

ClinicalTrials.gov Identifier: NCT00309608

Health Authority: Sweden: Medical Products Agency