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Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment

Phase 3
Terminated
Conditions
Type 2 Diabetes Mellitus
Renal 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
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
GroupInterventionDescription
dutogliptin (single-blind, active-controlled period)dutogliptinweeks 27-52
placebo (double-blind, placebo-controlled period)placeboweeks 1-26
placebo (single-blind, active-controlled period)placeboweeks 27-52
sitagliptin (single-blind, active-controlled period)sitagliptinweeks 27-52
dutogliptin (double-blind, placebo-controlled period)dutogliptinweeks 1-26
Primary Outcome Measures
NameTimeMethod
Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGsDay 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
NameTimeMethod
Change of HbA1cDay 1 to Day 182
Change of fasting plasma glucoseDay 1 to Day 182
Plasma dutogliptin levelsDays 1, 198 and 182
Per cent ex vivo DPP4 inhibition after drug dosingDays 1, 98, and 182

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

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