Status:
TERMINATED
Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Lead Sponsor:
Phenomix
Collaborating Sponsors:
Forest Laboratories
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability ...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
- Age 18 to 85 years, inclusive.
- Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
- Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
- HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (\> 0.8 ng/mL; \> 281 pmol/L) at screening (Visit 1)
Exclusion
- Type 1 diabetes mellitus
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00850239
Start Date
May 1 2009
End Date
December 1 2010
Last Update
August 11 2010
Active Locations (97)
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1
Phenomix Investigational Site 115
Montgomery, Alabama, United States
2
Phenomix Investigational Site 121
Tempe, Arizona, United States
3
Phenomix Investigational Site 137
Tempe, Arizona, United States
4
Phenomix Investigational Site 105
Anaheim, California, United States