Status:
COMPLETED
Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus
Lead Sponsor:
Phenomix
Collaborating Sponsors:
Forest Laboratories
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
- BMI 25 to 48 kg/m2, inclusive
- HbA1c 7.0% - 10.0%, inclusive
- Age 18 to 75 years, inclusive
Exclusion
- Currently on 3 or more oral antidiabetic drugs or insulin.
- Type 1 diabetes mellitus
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00690638
Start Date
July 1 2008
End Date
April 1 2010
Last Update
April 13 2010
Active Locations (62)
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1
Norwalk, California, United States
2
Orange, California, United States
3
Santa Ana, California, United States
4
Daytona Beach, Florida, United States