Status:
TERMINATED
Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Phenomix
Conditions:
Diabetes Mellitus, Type II
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
- BMI 20 to 48 kg/m2, inclusive
- HbA1c 7.0% - 10.0%, inclusive
- Age 18 to 85 years, inclusive
Exclusion
- Currently taking more than one oral hypoglycemic agent
- Type 1 diabetes mellitus
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00970424
Start Date
August 1 2009
Last Update
September 21 2011
Active Locations (118)
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1
Forest Investigative Site 064
Birmingham, Alabama, United States, 35205
2
Forest Investigative Site 020
Birmingham, Alabama, United States, 35235
3
Forest Investigative Site 059
Chandler, Arizona, United States, 85225
4
Forest Investigative Site 096
Litchfield, Arizona, United States, 85340