Efficacy and Safety of Pioglitazone and Azilsartan in Treating Subjects With Type 2 Diabetes Mellitus
NCT00762736 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 704
Last updated 2012-02-28
Summary
The purpose of this study is to determine the efficacy of pioglitazone, once daily (QD), combined with azilsartan in the treatment of subjects with Type 2 Diabetes Mellitus.
Conditions
Interventions
- DRUG
-
Pioglitazone and azilsartan
Pioglitazone 15 mg, tablets, orally, once daily and azilsartan 5 mg, tablets, orally, once daily for up to 24 weeks.
- DRUG
-
Pioglitazone and azilsartan
Pioglitazone 15 mg, tablets, orally, once daily and azilsartan 40 mg, tablets, orally, once daily for up to 24 weeks.
- DRUG
-
Pioglitazone
Pioglitazone 15 mg, tablets, orally, once daily and azilsartan placebo-matching tablets, orally, once daily for up to 24 weeks.
- DRUG
-
Pioglitazone and azilsartan
Pioglitazone 45 mg, tablets, orally, once daily and azilsartan 5 mg, tablets, orally, once daily for up to 24 weeks.
- DRUG
-
Pioglitazone and azilsartan
Pioglitazone 45 mg, tablets, orally, once daily and azilsartan 40 mg, tablets, orally, once daily for up to 24 weeks.
- DRUG
-
Pioglitazone
Pioglitazone 45 mg, tablets, orally, once daily and azilsartan placebo-matching tablets, orally, once daily for up to 24 weeks.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
VP Clinical Science Strategy · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-07-31
- Primary Completion
- 2005-10-31
- Completion
- 2005-10-31
Countries
- United States
- Argentina
- Chile
- Mexico
- Peru
Study Locations
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