Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
NCT01193218 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 547
Last updated 2014-06-17
Summary
This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Placebo (low dose)
Placebo tablets once a day
- DRUG
-
Placebo (low dose)
Placebo tablets once a day
- DRUG
-
Placebo (mid dose)
Placebo tablets once a day
- DRUG
-
Placebo (high dose)
Placebo tablets once a day
- DRUG
-
BI 10773
BI 10773 tablets low dose once a day
- DRUG
-
Placebo (mid dose)
Placebo tablets once a day
- DRUG
-
Placebo (high dose)
Placebo tablets once a day
- DRUG
-
Placebo (high dose)
Placebo tablets once a day
- DRUG
-
BI 10773
BI 10773 tablets mid-high dose once a day
- DRUG
-
BI 10773
BI 10773 tablets high dose once a day
- DRUG
-
Placebo (mid dose)
Placebo tablets once a day
- DRUG
-
Placebo (high dose)
Placebo tablets once a day
- DRUG
-
Placebo (low dose)
Placebo tablets once a day
- DRUG
-
Placebo (low dose)
Placebo tablets once a day
- DRUG
-
BI 10773
BI 10773 tablets mid-low dose once a day
- DRUG
-
Placebo (mid dose)
Placebo tablets once a day
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
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-09-30
- Primary Completion
- 2012-06-30
- Completion
- 2012-06-30
Countries
- Japan
Study Locations
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