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

This study has been terminated.
Sponsor:
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT01101945
First received: April 8, 2010
Last updated: August 10, 2010
Last verified: August 2010

April 8, 2010
August 10, 2010
July 2007
January 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01101945 on ClinicalTrials.gov Archive Site
To demonstrate maintenance or lowering of HbA1c and fasting blood glucose [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: dutogliptin
400 mg QD
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
339
March 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   India,   Mexico
 
NCT01101945
PHX1149-PROT202E
Not Provided
Hans-Peter Guler, MD, Phenomix Corporation
Phenomix
Not Provided
Not Provided
Phenomix
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP