A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control
Overview
- Phase
- Phase 3
- Intervention
- Bi 1356 + metformin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 857
- Locations
- 138
- Primary Endpoint
- HbA1c Change From Baseline at Week 24
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 1356 + metformin
BI 1356 low dose + metformin 500 mg, twice daily
Intervention: Bi 1356 + metformin
matching placebo
matching placebo
Intervention: matching placebo
BI 1356+ Metformin
BI 1356 low dose + metformin 1000 mg, twice daily
Intervention: Bi 1356 + metformin
Metformin
Metformin 500 mg, twice daily
Intervention: metformin
metformin
Metformin 1000 mg, twice daily
Intervention: metformin
BI 1356
BI 1356 high dose, once daily
Intervention: BI 1356
Outcomes
Primary Outcomes
HbA1c Change From Baseline at Week 24
Time Frame: Baseline and week 24
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Secondary Outcomes
- HbA1c Change From Baseline at Week 6(Baseline and week 6)
- HbA1c Change From Baseline at Week 12(Baseline and week 12)
- HbA1c Change From Baseline at Week 18(Baseline and week 18)
- FPG Change From Baseline at Week 24(Baseline and week 24)
- FPG Change From Baseline at Week 2(Baseline and week 2)
- FPG Change From Baseline at Week 6(Baseline and week 6)
- FPG Change From Baseline at Week 12(Baseline and week 12)
- FPG Change From Baseline at Week 18(Baseline and week 18)
- Percentage of Patients With HbA1c <7.0% at Week 24(Baseline and Week 24)
- Percentage of Patients With HbA1c<7.0 at Week 24(Baseline and Week 24)
- Percentage of Patients With HbA1c <6.5% at Week 24(Baseline and Week 24)
- Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24(Baseline and week 24)
- Percentage of Patients With HbA1c < 6.5% at Week 24(Baseline and Week 24)
- HbA1c Change From Baseline at Week 24 for Open-label Patients(Baseline and week 24)
- FPG Change From Baseline at Week 24 for Open-label Patients(Baseline and week 24)
- Use of Rescue Therapy(24 weeks)
- Percentage of Patients With HbA1c Lowering by 0.5% at Week 24(Baseline and week 24)