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

February 1, 2010 updated by: Phenomix

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Kemerovo, Russian Federation
        • Phenomix Investigational Site 208
      • Moscow, Russian Federation
        • Phenomix Investigational Site 203
      • Moscow, Russian Federation
        • Phenomix Investigational Site 204
      • Moscow, Russian Federation
        • Phenomix Investigational Site 209
      • Moscow, Russian Federation
        • Phenomix Investigational Site 211
      • Novosibirsk, Russian Federation
        • Phenomix Investigational Site 205
      • Perm., Russian Federation
        • Phenomix Investigational Site 207
      • Petrozavodsk, Russian Federation
        • Phenomix Investigational Site 206
      • St. Petersburg, Russian Federation
        • Phenomix Investigational Site 200
      • St. Petersburg, Russian Federation
        • Phenomix Investigational Site 201
      • St. Petersburg, Russian Federation
        • Phenomix Investigational Site 210
      • St. Petersburg, Russian Federation
        • Phenomix Investigational Site 212
      • St. Petersburg, Russian Federation
        • Phenomix Investigational Site 213
  • Ukraine
      • Chernivtsi, Ukraine
        • Phenomix Investigational Site 304
      • Kyiv, Ukraine
        • Phenomix Investigational Site 300
      • Kyiv, Ukraine
        • Phenomix Investigational Site 301
      • Kyiv, Ukraine
        • Phenomix Investigational Site 306
      • Odesa, Ukraine
        • Phenomix Investigational Site 302
      • Vinnytsa, Ukraine
        • Phenomix Investigational Site 303
      • Zaporizhzhya, Ukraine
        • Phenomix Investigational Site 307
  • United States
    • Arizona
      • Tempe, Arizona, United States
        • Phenomix Investigational Site 115
    • California
      • Long Beach, California, United States
        • Phenomix Investigational Site 121
      • Lynwood, California, United States
        • Phenomix Investigational Site 110
      • Lynwood, California, United States
        • Phenomix Investigational Site 118
      • Orange, California, United States
        • Phenomix Investigational Site 119
      • Palm Springs, California, United States
        • Phenomix Investigational Site 109
      • Whittier, California, United States
        • Phenomix Investigational Site 122
    • Florida
      • Lauderdale Lakes, Florida, United States
        • Phenomix Investigational Site 112
      • Ocala, Florida, United States
        • Phenomix Investigational Site 104
      • Pembroke Pines, Florida, United States
        • Phenomix Investigational Site 116
    • Georgia
      • Augusta, Georgia, United States
        • Phenomix Investigational Site 101
    • Hawaii
      • Honolulu, Hawaii, United States
        • Phenomix Investigational Site 117
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Phenomix Investigational Site 102
    • Maryland
      • Rockville, Maryland, United States
        • Phenomix Investigational Site 100
      • Rockville, Maryland, United States
        • Phenomix Investigational Site 125
    • New York
      • Springfield Gardens, New York, United States
        • Phenomix Investigational Site 114
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Phenomix Investigational Site 120
    • South Carolina
      • Columbia, South Carolina, United States
        • Phenomix Investigational Site 107
    • Tennessee
      • Nashville, Tennessee, United States
        • Phenomix Investigational Site 111
    • Texas
      • Fort Worth, Texas, United States
        • Phenomix Investigational Site 103
      • Houston, Texas, United States
        • Phenomix Investigational Site 106
      • San Antonio, Texas, United States
        • Phenomix Investigational Site 108
    • Virginia
      • Alexandria, Virginia, United States
        • Phenomix Investigational Site 113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phenomix

Collaborators

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

August 12, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (Estimate)

August 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHX1149-PROT306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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