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Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

This study has been terminated.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT00998686
First received: October 16, 2009
Last updated: August 10, 2010
Last verified: August 2010

October 16, 2009
August 10, 2010
November 2009
October 2011   (final data collection date for primary outcome measure)
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00998686 on ClinicalTrials.gov Archive Site
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: dutogliptin
    400 mg
  • Drug: sitagliptin
    100 mg
  • Experimental: dutogliptin/PHX1149T
    Intervention: Drug: dutogliptin
  • Active Comparator: sitagliptin
    Intervention: Drug: sitagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
650
November 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of all required visits of a qualifying Phase 3 core protocol
  • Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302

Exclusion Criteria:

  • 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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Czech Republic,   India,   Peru,   Poland
 
NCT00998686
PHX1149-PROT402
No
Michael Huang, MD, Phenomix
Phenomix
Forest Laboratories
Not Provided
Phenomix
August 2010

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