Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone
NCT00970424 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252
Last updated 2011-09-21
Summary
This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.
Conditions
- Diabetes Mellitus, Type II
Interventions
- DRUG
-
placebo, oral tablet administered once daily on background of pioglitazone
- DRUG
-
Dutogliptin
dutogliptin, oral tablet administered once daily on background of pioglitazone
Sponsors & Collaborators
-
Phenomix
collaborator INDUSTRY -
Forest Laboratories
lead INDUSTRY
Principal Investigators
-
Kaity Posada, PharmD · Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2010-08-31
Countries
- United States
- Belarus
- Germany
- India
- Lithuania
- Romania
Study Locations
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