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


Tracking Information

Start Date  ICMJEAugust 2009
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 12, 2009)		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 ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00958269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: August 12, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy to Evaluate Safety and Efficacy of Dutogliptin in Type 2 Diabetes Mellitus Subjects With Moderate and Severe Renal Impairment
Official Title  ICMJEA 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
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 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Renal Impairment
Intervention  ICMJE
  • Drug: dutogliptin
    100 mg QD
  • Drug: dutogliptin
    200 mg QD
  • Drug: placebo
  • Drug: sitagliptin
    25 mg QD
  • Drug: sitagliptin
    50 mg QD
Study Arms / Comparison Groups
  • dutogliptin (double-blind, placebo-controlled period): Experimental
    weeks 1-26
    Interventions:
    • Drug: dutogliptin
    • Drug: dutogliptin
  • dutogliptin (single-blind, active-controlled period): Experimental
    weeks 27-52
    Interventions:
    • Drug: dutogliptin
    • Drug: dutogliptin
  • placebo (double-blind, placebo-controlled period): Placebo Comparator
    weeks 1-26
    Intervention: Drug: placebo
  • placebo (single-blind, active-controlled period): Placebo Comparator
    weeks 27-52
    Intervention: Drug: placebo
  • sitagliptin (single-blind, active-controlled period): Active Comparator
    weeks 27-52
    Interventions:
    • Drug: sitagliptin
    • Drug: sitagliptin

Recruitment Information

Estimated Enrollment  ICMJE360
Estimated Completion DateNovember 2011
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Gayle Bresnahangayle.bresnahan@phenomix.com
Location Countries  ICMJEUnited States,   Russian Federation,   Ukraine

Administrative Information

NCT ID  ICMJENCT00958269
Responsible PartyHans-Peter Guler, MD, Phenomix Corporation
Study ID Numbers  ICMJEPHX1149-PROT306
Study Sponsor  ICMJEPhenomix
Collaborators  ICMJEForest Laboratories
Investigators  ICMJE 
Information Provided ByPhenomix