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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014