Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

August 10, 2010 updated by: Phenomix

An Open Label, Multi-Center, Long-Term Follow-up Study to Evaluate the Safety of PHX1149T in Subjects With Type 2 Diabetes Mellitus - Extension to Protocol PHX1149-PROT202

The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

339

Phase

  • Phase 2

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
      • Corrientes, Argentina
    • Buenos Aires
      • Cuidad Autonoma de Buenos Aires, Buenos Aires, Argentina
      • La Plata, Buenos Aires, Argentina
      • Lanus Este, Buenos Aires, Argentina
      • Moron, Buenos Aires, Argentina
      • Quilmes, Buenos Aires, Argentina
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Red Deer, Alberta, Canada
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
      • St. John's, Newfoundland and Labrador, Canada
    • Ontario
      • Etobicoke, Ontario, Canada
      • London, Ontario, Canada
      • Samia, Ontario, Canada
      • Toronto, Ontario, Canada
    • Prince Edward Island
      • Cornwall, Prince Edward Island, Canada
    • Quebec
      • Mirabel, Quebec, Canada
      • Montreal, Quebec, Canada
  • India
    • Ahmedabad
      • Ellisbridge, Ahmedabad, India
    • Hyderabad
      • Banjara Hills, Hyderabad, India
      • Punjagutta, Hyderabad, India
    • Maharashtra
      • Pune, Maharashtra, India
    • Mumbai
      • Tardeo, Mumbai, India
    • Nagpur
      • Dhantoli, Nagpur, India
    • Tamilnadu
      • Chennai, Tamilnadu, India
  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
    • Michoacan
      • Morelia, Michoacan, Mexico
    • Nuevo Leon
      • Monterrey N. L., Nuevo Leon, Mexico
  • United States
    • California
      • Fullerton, California, United States
      • Long Beach, California, United States
      • Orange, California, United States
      • San Diego, California, United States
    • Florida
      • Kissimmee, Florida, United States
      • Melbourne, Florida, United States
      • New Port Richey, Florida, United States
    • Illinois
      • Gurnee, Illinois, United States
    • Kansas
      • Wichita, Kansas, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Nevada
      • Henderson, Nevada, United States
      • Las Vegas, Nevada, United States
    • New Jersey
      • Berlin, New Jersey, United States
      • Margate City, New Jersey, United States
      • Trenton, New Jersey, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
    • Pennsylvania
      • Warminster, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Greer, South Carolina, United States
    • Texas
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completed Visit 7/Day 98 of the core protocol PHX1149-PROT202
  • Current treatment of Type 2 diabetes mellitus in accordance with product labeling with metformin, or thiazolidinedione (TZD), or metformin + TZD

Exclusion Criteria:

  • Inadequately controlled Type 2 diabetes mellitus with need for therapy with insulin

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
Time Frame: 104 weeks
104 weeks
To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
Time Frame: 208 weeks (U.S. only)
208 weeks (U.S. only)

Secondary Outcome Measures

Outcome Measure
Time Frame
To demonstrate maintenance or lowering of HbA1c and fasting blood glucose
Time Frame: 104 weeks
104 weeks

Collaborators and Investigators

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

Sponsor

Phenomix

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

July 1, 2007

Primary Completion (ANTICIPATED)

January 1, 2010

Study Completion (ANTICIPATED)

March 1, 2010

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (ESTIMATE)

April 12, 2010

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-PROT202E

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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