Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
NCT01177813 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 986
Last updated 2014-06-16
Summary
The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Placebo identical to BI10773 high dose
placebo tablets once daily
- DRUG
-
BI 10773
BI 10773 low dose tablet once daily
- DRUG
-
BI 10773 open label
Patients receive BI 10773 high dose tablets open label once daily
- DRUG
-
Placebo identical to BI10773 low dose
placebo tablets once daily
- DRUG
-
Placebo identical to BI10773 low dose
placebo tablets once daily
- DRUG
-
Placebo identical to BI10773 high dose
placebo tablets once daily
- DRUG
-
Placebo identical to Sitagliptin 100mg
placebo tablets once daily
- DRUG
-
Placebo identical to Sitagliptin 100mg
placebo tablets once daily
- DRUG
-
BI10773
BI 10773 high dose tablets once daily
- DRUG
-
Sitagliptin
Sitagliptin tablets 100 mg once daily
- DRUG
-
Placebo identical to Sitagliptin 100mg
placebo tablets once daily
- DRUG
-
Placebo identical to BI10773 low dose
placebo tablets once daily
- DRUG
-
Placebo identical to BI10773 high dose
placebo tablets once daily
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2012-03-31
Countries
- United States
- Belgium
- Canada
- China
- Germany
- India
- Ireland
- Japan
- Switzerland
Study Locations
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