Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Phase 2
Terminated
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT01101945
- Lead Sponsor
- Phenomix
- Brief Summary
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 339
Inclusion Criteria
- Completed Visit 7/Day 98 of the core protocol PHX1149-PROT202
- Current treatment of Type 2 diabetes mellitus in accordance with product labeling with metformin, or thiazolidinedione (TZD), or metformin + TZD
Exclusion Criteria
- Inadequately controlled Type 2 diabetes mellitus with need for therapy with insulin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments 104 weeks To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments 208 weeks (U.S. only)
- Secondary Outcome Measures
Name Time Method To demonstrate maintenance or lowering of HbA1c and fasting blood glucose 104 weeks