Safety and Efficacy Study of Dutogliptin/PHX1149T 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, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

700

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 401
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 402
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 404
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 405
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 406
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 407
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 408
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 409
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 411
      • Corrientes, Argentina
        • Phenomix Investigational Site 403
      • Mendoza, Argentina
        • Phenomix Investigational Site 410
      • Rosario, Argentina
        • Phenomix Investigational Site 400
  • Chile
      • Santiago, Chile
        • Phenomix Investigational Site 502
      • Santiago, Chile
        • Phenomix Investigational Site 504
      • Santiago, Chile
        • Phenomix Investigational Site 505
      • Temuco, Chile
        • Phenomix Investigational Site 500
      • Temuco, Chile
        • Phenomix Investigational Site 501
  • Czech Republic
      • Chodov, Czech Republic
        • Phenomix Investigational Site 209
      • Havířov-Město, Czech Republic
        • Phenomix Investigational Site 205
      • Liberec, Czech Republic
        • Phenomix Investigational Site 204
      • Olomouc, Czech Republic
        • Phenomix Investigational Site 202
      • Ostrava Kunčice, Czech Republic
        • Phenomix Investigational Site 206
      • Praha, Czech Republic
        • Phenomix Investigational Site 208
      • Prostějov, Czech Republic
        • Phenomix Investigational Site 203
      • Uničov, Czech Republic
        • Phenomix Investigational Site 207
      • Valašské Klobouky, Czech Republic
        • Phenomix Investigational Site 201
  • India
      • Chennai, India
        • Phenomix Investigational Site 708
    • Andhara Pradesh
      • Hyderabad, Andhara Pradesh, India
        • Phenomix Investigational Site 703
    • Andhra Pradesh
      • Visakhapatanam, Andhra Pradesh, India
        • Phenomix Investigational Site 704
    • Chennai
      • Gopalapuram, Chennai, India
        • Phenomix Investigational Site 709
    • Jaipur
      • Shastrinagar, Jaipur, India
        • Phenomix Investigational Site 707
    • Karnataka
      • Bangalore, Karnataka, India
        • Phenomix Investigational Site 701
      • Bangalore, Karnataka, India
        • Phenomix Investigational Site 702
    • Kerala
      • Trivandrum, Kerala, India
        • Phenomix Investigational Site 705
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
        • Phenomix Investigational Site 706
    • Maharashtra
      • Nashik, Maharashtra, India
        • Phenomix Investigational Site 700
      • Navi Mumbai, Maharashtra, India
        • Phenomix Investigational Site 710
    • Maharastra
      • Mumbai, Maharastra, India
        • Phenomix Investigational Site 711
  • Peru
      • Arequipa, Peru
        • Phenomix Investigational Site 607
      • Cercado de Lima, Peru
        • Phenomix Investigational Site 605
      • Ica, Peru
        • Phenomix Investigational Site 601
      • Lima, Peru
        • Phenomix Investigational Site 600
      • Lima, Peru
        • Phenomix Investigational Site 603
      • Lima, Peru
        • Phenomix Investigational Site 604
      • Lima, Peru
        • Phenomix Investigational Site 608
      • Lima, Peru
        • Phenomix Investigational Site 610
      • Piura, Peru
        • Phenomix Investigational Site 606
      • Trujillo, Peru
        • Phenomix Investigational Site 602
      • Wanchaq Cusco, Peru
        • Phenomix Investigational Site 609
  • Poland
      • Gdańsk, Poland
        • Phenomix Investigational Site 300
      • Gdańsk, Poland
        • Phenomix Investigational Site 301
      • Katowice, Poland
        • Phenomix Investigational Site 303
      • Katowice, Poland
        • Phenomix Investigational Site 312
      • Kraków, Poland
        • Phenomix Investigational Site 309
      • Kraków, Poland
        • Phenomix Investigational Site 313
      • Lublin, Poland
        • Phenomix Investigational Site 308
      • Poznan, Poland
        • Phenomix Investigational Site 310
      • Puławy, Poland
        • Phenomix Investigational Site 306
      • Szczecin, Poland
        • Phenomix Investigational Site 304
      • Warszawa, Poland
        • Phenomix Investigational Site 305
      • Warszawa, Poland
        • Phenomix Investigational Site 307
      • Warszawa, Poland
        • Phenomix Investigational Site 311
      • Wrocław, Poland
        • Phenomix Investigational Site 302
  • United States
    • Alabama
      • Montgomery, Alabama, United States
        • Phenomix Investigational Site 115
    • 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
      • Chico, California, United States
        • Phenomix Investigational Site 123
      • Escondido, California, United States
        • Phenomix Investigational Site 134
      • 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
      • Jacksonville, Florida, United States
        • Phenomix Investigational Site 119
      • Kissimmee, Florida, United States
        • Phenomix Investigational Site 133
    • Georgia
      • Dunwoody, Georgia, United States
        • Phenomix Investigational Site 141
    • 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
      • Indianapolis, Indiana, United States
        • Phenomix Investigational Site 127
    • Massachusetts
      • Brockton, Massachusetts, United States
        • Phenomix Investigational Site 136
    • Michigan
      • Kalamazoo, Michigan, United States
        • Phenomix Investigational Site 125
    • 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
      • Brick, New Jersey, United States
        • Phenomix Investigational Site 131
      • 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
    • Ohio
      • Cincinnati, Ohio, United States
        • Phenomix Investigational Site 130
      • Cuyahoga Falls, Ohio, United States
        • Phenomix Investigational Site 118
    • South Carolina
      • Greenville, South Carolina, United States
        • Phenomix Investigational Site 112
    • Texas
      • Dallas, Texas, United States
        • Phenomix Investigational Site 102
      • Dallas, Texas, United States
        • Phenomix Investigational Site 139
      • El Paso, Texas, United States
        • Phenomix Investigational Site 126
      • 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:

  • Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
  • Age 18 to 85 years, inclusive.
  • Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
  • Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
  • HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1)

Exclusion Criteria:

  • Type 1 diabetes mellitus

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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
dutogliptin/PHX1149T
Drug: dutogliptin
400 mg
Other Names:
  • PHX1149T
Placebo Comparator: 2
Plabeco
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Demonstrate safety and tolerability of dutogliptin
Time Frame: 26 weeks
26 weeks
• Demonstrate changes in fasting plasma glucose
Time Frame: 26 weeks
26 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

May 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (Estimate)

February 24, 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-PROT302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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