A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 494
- Locations
- 99
- Primary Endpoint
- Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment
Study Overview
Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 10773 low dose
Patients receive BI 10773 low dose daily
Intervention: BI 10773 low dose (Drug)
BI 10773 high dose
Patients receive BI 10773 high dose daily
Intervention: BI 10773 placebo (Drug)
BI 10773 high dose
Patients receive BI 10773 high dose daily
Intervention: BI 10773 high dose (Drug)
placebo
Patients receive placebo to match BI 10773 daily
Intervention: BI 10773 placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment
Time Frame: Baseline and 18 weeks
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment
Secondary Outcomes
- Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment(Baseline, 54 and 78 weeks)
- Change From Baseline in Body Weight at Follow-up(Baseline and 82 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment(Baseline, 18, 54 and 78 weeks)
- Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment(Baseline, 54 and 78 weeks)
- The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment(Baseline, 18, 54 and 78 weeks)
- Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment(Baseline and 18, 54 and 78 weeks)
- Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment(Baseline, 18, 54 and 78 weeks)
- Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment(Baseline, 18, 54, 78 weeks)