Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

August 10, 2010 updated by: Phenomix

A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

650

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

  • Argentina
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 402
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 408
      • Mendoza, Argentina
        • Phenomix Investigational Site 410
  • Czech Republic
      • Praha 10, Czech Republic
        • Phenomix Investigational Site 208
      • Praha 4 Chodov, Czech Republic
        • Phenomix Investigational Site 209
      • Unicov, Czech Republic
        • Phenomix Investigational Site 207
  • India
    • Jaipur
      • Shastrinagar, Jaipur, India
        • Phenomix Investigational Site 707
    • Karnataka
      • Bangalore, Karnataka, India
        • Phenomix Investigational Site 701
    • Kerala
      • Trivandrum, Kerala, India
        • Phenomix Investigational Site 705
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
        • Phenomix Investigational Site 706
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Phenomix Investigational Site 711
  • Peru
      • Arequipa, Peru
        • Phenomix Investigational Site 607
      • Ica, Peru
        • Phenomix Investigational Site 601
      • Lima, Peru
        • Phenomix Investigational Site 604
      • Lima, Peru
        • Phenomix Investigational Site 610
  • Poland
      • Gdansk, Poland
        • Phenomix Investigational Site 300
      • Karkow, Poland
        • Phenomix Investigational Site 309
      • Katowice, Poland
        • Phenomix Investigational Site 303
      • Pulawy, Poland
        • Phenomix Investigational Site 306
      • Warszawa, Poland
        • Phenomix Investigational Site 305
      • Wroclaw, Poland
        • Phenomix Investigational Site 302
  • United States
    • Alabama
      • Montgomery, Alabama, United States
        • Phenomix Investigational Site 105
    • Arizona
      • Tempe, Arizona, United States
        • Phenomix Investigational Site 121
      • Tempe, Arizona, United States
        • Phenomix Investigational Site 137
    • California
      • Anaheim, California, United States
        • Phenomix Investigational Site 105
      • Long Beach, California, United States
        • Phenomix Investigational Site 103
      • Los Angeles, California, United States
        • Phenomix Investigational Site 106
    • Florida
      • Coral Gables, Florida, United States
        • Phenomix Investigational Site 143
      • Hialeah, Florida, United States
        • Phenomix Investigational Site 142
      • Kissimmee, Florida, United States
        • Phenomix Investigational Site 133
    • Hawaii
      • Honolulu, Hawaii, United States
        • Phenomix Investigational Site 101
    • Illinois
      • Chicago, Illinois, United States
        • Phenomix Investigational Site 135
    • Indiana
      • Indianapolis, Indiana, United States
        • Phenomix Investigational Site 124
    • Massachusetts
      • Brockton, Massachusetts, United States
        • Phenomix Investigational Site 136
    • Mississippi
      • Biloxi, Mississippi, United States
        • Phenomix Investigational Site 138
    • Nevada
      • Las Vegas, Nevada, United States
        • Phenomix Investigational Site 122
      • Las Vegas, Nevada, United States
        • Phenomix Investigational Site 140
    • New Jersey
      • Trenton, New Jersey, United States
        • Phenomix Investigational Site 110
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Phenomix Investigational Site 116
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Phenomix Investigational Site 107
    • South Carolina
      • Greenville, South Carolina, United States
        • Phenomix Investigational Site 112
    • Texas
      • Dallas, Texas, United States
        • Phenomix Investigational Site 102
      • San Antonio, Texas, United States
        • Phenomix Investigational Site 104
    • Wisconsin
      • Kenosha, Wisconsin, United States
        • Phenomix Investigational Site 100

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:

  • Completion of all required visits of a qualifying Phase 3 core protocol
  • Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302

Exclusion Criteria:

  • Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dutogliptin/PHX1149T
Drug: dutogliptin
400 mg
Active Comparator: sitagliptin
Drug: sitagliptin
100 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose
Time Frame: 52 weeks
52 weeks

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

November 1, 2009

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 19, 2009

First Posted (Estimate)

October 20, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHX1149-PROT402

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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