A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
Overview
- Phase
- Phase 3
- Intervention
- BI 10773
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1504
- Locations
- 148
- Primary Endpoint
- HbA1c Change From Baseline
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 10773 Arm 2
BI 10773 once daily high dose
Intervention: BI 10773
BI 10773 Arm 2
BI 10773 once daily high dose
Intervention: Placebo identical to BI 10773 low dose
Placebo
Placebo matching BI 10773
Intervention: Placebo identical to BI 10773 low dose
Placebo
Placebo matching BI 10773
Intervention: Placebo identical to BI 10773 high dose
BI 10773 open-label
BI 10773 once daily high dose open label
Intervention: BI 10773
BI 10773 Arm 1
BI 10773 once daily low dose
Intervention: Placebo identical to BI 10773 high dose
BI 10773 Arm 1
BI 10773 once daily low dose
Intervention: BI 10773
Outcomes
Primary Outcomes
HbA1c Change From Baseline
Time Frame: Baseline and 24 weeks
Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Secondary Outcomes
- Body Weight Change From Baseline(Baseline and 24 weeks)
- Mean Daily Plasma Glucose (MDG) Change From Baseline(Baseline and 24 weeks)