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

This study has been terminated.
(Technical/operational issues)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT00958269
First received: August 12, 2009
Last updated: February 1, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Renal Impairment
Drug: dutogliptin
Drug: placebo
Drug: sitagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- and Sitagliptin-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment Including Subjects on Hemodialysis

Resource links provided by NLM:


Further study details as provided by Phenomix:

Primary Outcome Measures:
  • Safety and tolerability of dutogliptin as assessed by analysis of AEs/SAEs, laboratory data, vital signs, and ECGs [ Time Frame: 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change of HbA1c [ Time Frame: Day 1 to Day 182 ] [ Designated as safety issue: No ]
  • Change of fasting plasma glucose [ Time Frame: Day 1 to Day 182 ] [ Designated as safety issue: No ]
  • Plasma dutogliptin levels [ Time Frame: Days 1, 198 and 182 ] [ Designated as safety issue: No ]
  • Per cent ex vivo DPP4 inhibition after drug dosing [ Time Frame: Days 1, 98, and 182 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: August 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dutogliptin (double-blind, placebo-controlled period)
weeks 1-26
Drug: dutogliptin
100 mg QD
Drug: dutogliptin
200 mg QD
Experimental: dutogliptin (single-blind, active-controlled period)
weeks 27-52
Drug: dutogliptin
100 mg QD
Drug: dutogliptin
200 mg QD
Placebo Comparator: placebo (double-blind, placebo-controlled period)
weeks 1-26
Drug: placebo
Placebo Comparator: placebo (single-blind, active-controlled period)
weeks 27-52
Drug: placebo
Active Comparator: sitagliptin (single-blind, active-controlled period)
weeks 27-52
Drug: sitagliptin
25 mg QD
Drug: sitagliptin
50 mg QD

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958269

  Show 43 Study Locations
Sponsors and Collaborators
Phenomix
Forest Laboratories
  More Information

No publications provided

Responsible Party: Hans-Peter Guler, MD, Phenomix Corporation
ClinicalTrials.gov Identifier: NCT00958269     History of Changes
Other Study ID Numbers: PHX1149-PROT306
Study First Received: August 12, 2009
Last Updated: February 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Phenomix:
diabetes
DPP4 inhibitor
dutogliptin
PHX1149

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014