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

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ClinicalTrials.gov Identifier: NCT00958269
Recruitment Status : Terminated (Technical/operational issues)
First Posted : August 13, 2009
Last Update Posted : February 3, 2010
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Renal Impairment Drug: dutogliptin Drug: placebo Drug: sitagliptin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : August 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958269


  Show 43 Study Locations
Sponsors and Collaborators
Phenomix
Forest Laboratories

Responsible Party: Hans-Peter Guler, MD, Phenomix Corporation
ClinicalTrials.gov Identifier: NCT00958269     History of Changes
Other Study ID Numbers: PHX1149-PROT306
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

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 Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action