Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

This study has been completed.

Sponsor:

Collaborator:

Forest Laboratories

Information provided by:

Phenomix

ClinicalTrials.gov Identifier:

NCT00690638

First received: June 2, 2008

Last updated: April 12, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 2, 2008
Last Updated Date	April 12, 2010
Start Date ^ICMJE	July 2008
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 3, 2008)	To demonstrate changes in HbA1c [ Time Frame: Day 28 to Day 196 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00690638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
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/PHX1149T to Treat Type 2 Diabetes Mellitus
Official Title ^ICMJE	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus
Brief Summary	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Drug: PHX1149T 200 mg Other Name: dutogliptin Drug: PHX1149T 400 mg Other Name: dutogliptin Drug: Placebo Placebo
Study Arm (s)	Placebo Comparator: 1 Placebo Intervention: Drug: Placebo Experimental: 2 PHX1149T 200 mg Intervention: Drug: PHX1149T Experimental: 3 PHX1149T 400 mg Intervention: Drug: PHX1149T
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	Completed
Estimated Enrollment ^ICMJE	480
Completion Date	April 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy BMI 25 to 48 kg/m2, inclusive HbA1c 7.0% - 10.0%, inclusive Age 18 to 75 years, inclusive Exclusion Criteria: Currently on 3 or more oral antidiabetic drugs or insulin. Type 1 diabetes mellitus
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, India, Malaysia, Peru, Philippines, Romania, Thailand, Ukraine

Administrative Information
NCT Number ^ICMJE	NCT00690638
Other Study ID Numbers ^ICMJE	PHX1149-PROT301, EudraCT 2008-002614-22
Has Data Monitoring Committee	No
Responsible Party	Hans-Peter Guler, MD / Chief Medical Officer, Phenomix Corporation
Study Sponsor ^ICMJE	Phenomix
Collaborators ^ICMJE	Forest Laboratories
Investigators ^ICMJE	Not Provided
Information Provided By	Phenomix
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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