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

This study has been terminated.
Information provided by:
Phenomix Identifier:
First received: April 8, 2010
Last updated: August 10, 2010
Last verified: August 2010
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Phenomix:

Primary Outcome Measures:
  • 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 ]
  • 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) ]

Secondary Outcome Measures:
  • To demonstrate maintenance or lowering of HbA1c and fasting blood glucose [ Time Frame: 104 weeks ]

Enrollment: 339
Study Start Date: July 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dutogliptin
    400 mg QD

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01101945

  Show 55 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Hans-Peter Guler, MD, Phenomix Corporation Identifier: NCT01101945     History of Changes
Other Study ID Numbers: PHX1149-PROT202E
Study First Received: April 8, 2010
Last Updated: August 10, 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 processed this record on April 28, 2017