Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment
- Conditions
- Type 2 Diabetes MellitusRenal Impairment
- Interventions
- Registration Number
- NCT00958269
- Lead Sponsor
- Phenomix
- Brief Summary
The purpose of this study is to assess the safety and tolerability of dutogliptin in Type 2 diabetic subjects with moderate or severe renal impairment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 360
- Type 2 diabetes mellitus
- Renal impairment (moderate and severe)
- Currently on stable doses of background medication of SU, TZD, acarbose, meglitinide, insulin or any combination thereof, or on no antidiabetic drugs at all
- HbA1c 7.0% - 10.5%, inclusive
- Male or female subjects between the ages of 18 and 85 years, inclusive.
- Type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (MODY)
- Kidney transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dutogliptin (single-blind, active-controlled period) dutogliptin weeks 27-52 placebo (double-blind, placebo-controlled period) placebo weeks 1-26 placebo (single-blind, active-controlled period) placebo weeks 27-52 sitagliptin (single-blind, active-controlled period) sitagliptin weeks 27-52 dutogliptin (double-blind, placebo-controlled period) dutogliptin weeks 1-26
- Primary Outcome Measures
Name Time Method Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs Day 1 through day 182 (end of the 26-week, double-blind, placebo-controlled period) and through Day 364 (end of the 26-week, sitagliptin-controlled period of the study)
- Secondary Outcome Measures
Name Time Method Change of HbA1c Day 1 to Day 182 Change of fasting plasma glucose Day 1 to Day 182 Plasma dutogliptin levels Days 1, 198 and 182 Per cent ex vivo DPP4 inhibition after drug dosing Days 1, 98, and 182
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (43)
Phenomix Investigational Site 115
🇺🇸Tempe, Arizona, United States
Phenomix Investigational Site 121
🇺🇸Long Beach, California, United States
Phenomix Investigational Site 110
🇺🇸Lynwood, California, United States
Phenomix Investigational Site 118
🇺🇸Lynwood, California, United States
Phenomix Investigational Site 119
🇺🇸Orange, California, United States
Phenomix Investigational Site 109
🇺🇸Palm Springs, California, United States
Phenomix Investigational Site 122
🇺🇸Whittier, California, United States
Phenomix Investigational Site 112
🇺🇸Lauderdale Lakes, Florida, United States
Phenomix Investigational Site 104
🇺🇸Ocala, Florida, United States
Phenomix Investigational Site 116
🇺🇸Pembroke Pines, Florida, United States
Scroll for more (33 remaining)Phenomix Investigational Site 115🇺🇸Tempe, Arizona, United States