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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 16, 2009
Last Updated Date	August 10, 2010
Start Date ^ICMJE	November 2009
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 19, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00998686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 19, 2009)	To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Official Title ^ICMJE	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
Brief Summary	The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Drug: dutogliptin 400 mg Drug: sitagliptin 100 mg
Study Arm (s)	Experimental: dutogliptin/PHX1149T Intervention: Drug: dutogliptin Active Comparator: sitagliptin Intervention: Drug: sitagliptin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	650
Estimated Completion Date	November 2011
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Czech Republic, India, Peru, Poland

Administrative Information
NCT Number ^ICMJE	NCT00998686
Other Study ID Numbers ^ICMJE	PHX1149-PROT402
Has Data Monitoring Committee	No
Responsible Party	Michael Huang, MD, Phenomix
Study Sponsor ^ICMJE	Phenomix
Collaborators ^ICMJE	Forest Laboratories
Investigators ^ICMJE	Not Provided
Information Provided By	Phenomix
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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