Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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)
Forest Laboratories
Information provided by:
Phenomix Identifier:
First received: August 12, 2009
Last updated: February 1, 2010
Last verified: February 2010
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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) ]

Secondary Outcome Measures:
  • Change of HbA1c [ Time Frame: Day 1 to Day 182 ]
  • Change of fasting plasma glucose [ Time Frame: Day 1 to Day 182 ]
  • Plasma dutogliptin levels [ Time Frame: Days 1, 198 and 182 ]
  • Per cent ex vivo DPP4 inhibition after drug dosing [ Time Frame: Days 1, 98, and 182 ]

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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00958269

  Show 43 Study Locations
Sponsors and Collaborators
Forest Laboratories
  More Information

Responsible Party: Hans-Peter Guler, MD, Phenomix Corporation Identifier: NCT00958269     History of Changes
Other Study ID Numbers: PHX1149-PROT306
Study First Received: August 12, 2009
Last Updated: February 1, 2010

Keywords provided by Phenomix:
DPP4 inhibitor

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 Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017