A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by:

Surface Logix

ClinicalTrials.gov Identifier:

NCT00871936

First received: March 26, 2009

Last updated: December 14, 2009

Last verified: August 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 26, 2009
Last Updated Date	December 14, 2009
Start Date ^ICMJE	April 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 26, 2009)	Reduction in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00871936 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 26, 2009)	Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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	A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes
Official Title ^ICMJE	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of SLx-4090 in Combination With Metformin in Subjects With Type 2 Diabetes
Brief Summary	The purpose of this study is to determine whether SLx-4090 in combination with metformin therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin therapy alone.
Detailed Description	HbA1c after 12 weeks FPG after 12 weeks Safety and tolerability Plasma levels of SLx-4090
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: SLx-4090 tablets Other: Placebo matching tablets
Study Arm (s)	Experimental: 1 SLx-4090 Intervention: Drug: SLx-4090 2 Placebo Intervention: Other: Placebo
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
Enrollment ^ICMJE	82
Completion Date	October 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: HbA1c 7-11% On a stable dose of metformin for at least 6 weeks Exclusion Criteria: Type 1 Diabetes Antidiabetic medication other than or in addition to metformin FPG > 270 mg/dL
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00871936
Other Study ID Numbers ^ICMJE	SLx-4090-09-07
Has Data Monitoring Committee	No
Responsible Party	Warwick Tong, MB ChB, Surface Logix, Inc.
Study Sponsor ^ICMJE	Surface Logix
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Surface Logix
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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