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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00865592
First Posted: March 19, 2009
Last Update Posted: August 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Forest Laboratories
Information provided by:
Phenomix
  Purpose
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

Condition Intervention Phase
Type 2 Diabetes Mellitus Type 2 Diabetes Drug: dutogliptin Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus

Further study details as provided by Phenomix:

Primary Outcome Measures:
  • To demonstrate safety and tolerability of dutogliptin [ Time Frame: Two years ]

Secondary Outcome Measures:
  • To demonstrate maintenance or lowering of HbA1c [ Time Frame: Two years ]
  • To demonstrate maintenance or lowering of fasting blood glucose [ Time Frame: Two years ]

Estimated Enrollment: 450
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dutogliptin
    dutogliptin 400 mg, once daily tablet
    Other Names:
    • PHX1149T
    • PHX1149
    • dutogliptin tartrate
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865592


  Show 68 Study Locations
Sponsors and Collaborators
Phenomix
Forest Laboratories
  More Information

Additional Information:
Responsible Party: Hans-Peter Guler, MD, Phenomix
ClinicalTrials.gov Identifier: NCT00865592     History of Changes
Other Study ID Numbers: PHX1149-PROT300E
First Submitted: March 17, 2009
First Posted: March 19, 2009
Last Update Posted: August 11, 2010
Last Verified: August 2010

Keywords provided by Phenomix:
diabetes
DPP4 inhibitor
dutogliptin
PHX1149

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases