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

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. Identifier: NCT00865592
Recruitment Status : Terminated
First Posted : March 19, 2009
Last Update Posted : August 11, 2010
Forest Laboratories
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Brief Summary:
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Type 2 Diabetes Drug: dutogliptin Phase 3

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  (Clinical Trial)
Estimated Enrollment : 450 participants
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
Study Start Date : March 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: dutogliptin
    dutogliptin 400 mg, once daily tablet
    Other Names:
    • PHX1149T
    • PHX1149
    • dutogliptin tartrate

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00865592

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Sponsors and Collaborators
Forest Laboratories

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

Keywords provided by Phenomix:
DPP4 inhibitor

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