A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 302
- Locations
- 71
- Primary Endpoint
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo tablets matching BI 1356
Intervention: Placebo
BI 1356 0.5 mg
BI 1356 dose 1 once daily
Intervention: BI 1356 dose 1 once daily
BI 1356 2.5 mg
BI 1356 dose 2 once daily
Intervention: BI 1356 dose 2 once daily
BI 1356 5.0 mg
BI 1356 dose 3 once daily
Intervention: BI 1356 dose 3 once daily
Metformin
Metformin
Intervention: Metformin
Outcomes
Primary Outcomes
Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12
Time Frame: Baseline, week 12
The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.
Secondary Outcomes
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12(Baseline, week 12)
- Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks(Baseline, week 12)