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: Drug: dutogliptin; Drug: placebo; Drug: sitagliptin

• 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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-03
• Primary Completion: 2011-09
• Study Completion: 2011-11

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

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

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

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