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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.

Study Type

Interventional

Enrollment (Anticipated)

450

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 103
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 110
      • Buenos Aires, Argentina
        • Phenomix Investigational Site 111
      • Caba, Argentina
        • Phenomix Investigational Site 106
      • Corrientes, Argentina
        • Phenomix Investigational Site 112
      • Paraná, Argentina
        • Phenomix Investigational Site 102
  • India
      • Bangalore, Karnataka, India
      • Chennai, Tamil Nadu, India
      • Gulbarga, Karnataka, India
      • Hyderabad, Andhara Pradesh, India
      • Mumbai, Maharashtra, India
      • Nagpur, Maharashtra, India
      • Nashik, Maharashtra, India
      • Navi Mumbai, Maharashtra, India
      • Pune, Maharashtra, India
  • Malaysia
      • Kelantan, Malaysia
      • Kuala Lumpur, Malaysia
      • Perak, Malaysia
      • Putrajaya, Malaysia
        • Phenomix Investigational Site 404
      • Sarawak, Malaysia
    • Sarawak
      • Kuching, Sarawak, Malaysia
        • Phenomix Investigational Site 403
  • Peru
      • Arequipa, Peru
        • Phenomix Investigational Site 604
      • Lambayeque, Peru
        • Phenomix Investigational Site 606
      • Lima, Peru
        • Phenomix Investigational Site 600
      • Lima, Peru
        • Phenomix Investigational Site 601
      • Lima, Peru
        • Phenomix Investigational Site 602
      • Lima, Peru
        • Phenomix Investigational Site 609
  • Philippines
      • Cebu City, Philippines
        • Phenomix Investigational Site 703
      • Manila, NCR, Philippines
      • Quezon City, NCR, Philippines
      • San Juan, NCR, Philippines
  • Romania
      • Brasov, Romania
        • Phenomix Investigational Site 802
      • Brasov, Romania
        • Phenomix Investigational Site 806
      • Bucharest, Romania
        • Phenomix Investigational Site 800
      • Bucharest, Romania
        • Phenomix Investigational Site 803
      • Bucharest, Romania
        • Phenomix Investigational Site 805
      • Bucharest, Romania
        • Phenomix Investigational Site 807
      • Galati, Romania
        • Phenomix Investigational Site 804
      • Ploieşti, Romania
        • Phenomix Investigational Site 801
      • Sibiu, Romania
        • Phenomix Investigational Site 808
  • Ukraine
      • Ivano-Frankivsk, Ukraine
        • Phenomix Investigational Site 551
      • Kharkiv, Ukraine
        • Phenomix Investigational Site 557
      • Kharkiv, Ukraine
        • Phenomix Investigational Site 564
      • Kharkov, Ukraine
        • Phenomix Investigational Site 550
      • Kiev, Ukraine
        • Phenomix Investigational Site 555
      • Kiev, Ukraine
        • Phenomix Investigational Site 556
      • Kiev, Ukraine
        • Phenomix Investigational Site 562
      • Kiev, Ukraine
        • Phenomix Investigational Site 563
      • Kylv, Ukraine
        • Phenomix Investigational Site 554
      • Lutsk, Ukraine
        • Phenomix Investigational Site 565
      • Lviv, Ukraine
        • Phenomix Investigational Site 553
      • Poltava, Ukraine
        • Phenomix Investigational Site 561
      • Simferopol, Ukraine
        • Phenomix Investigational Site 560
      • Vinnitsa, Ukraine
        • Phenomix Investigational Site 559
      • Zaporzhzhia, Ukraine
        • Phenomix Investigational Site 552
  • United States
    • California
      • Norwalk, California, United States
      • Orange, California, United States
      • Santa Ana, California, United States
    • Florida
      • Daytona Beach, Florida, United States
      • Kissimmee, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
        • Phenomix Investigational Site 663
    • Massachusetts
      • Brockton, Massachusetts, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Texas
      • El Paso, Texas, United States
      • San Antonio, Texas, 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 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 (e.g., Visit 8/Day 196 of PHX1149-PROT301)
  • Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301

Exclusion Criteria:

  • Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate safety and tolerability of dutogliptin
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
To demonstrate maintenance or lowering of HbA1c
Time Frame: Two years
Two years
To demonstrate maintenance or lowering of fasting blood glucose
Time Frame: Two years
Two years

Collaborators and Investigators

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

Sponsor

Phenomix

Collaborators

Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

March 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 19, 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-PROT300E

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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