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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: SLx-4090
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Surface Logix:

Primary Outcome Measures:
  • Reduction in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: April 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SLx-4090
Drug: SLx-4090
tablets
2
Placebo
Other: Placebo
matching tablets

Detailed Description:
  1. HbA1c after 12 weeks
  2. FPG after 12 weeks
  3. Safety and tolerability
  4. Plasma levels of SLx-4090
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871936

Locations
United States, California
Anaheim, California, United States, 92801
Burbank, California, United States, 91505
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90057
United States, Florida
West Palm Beach, Florida, United States, 33401
United States, Illinois
Addison, Illinois, United States, 60101
United States, Maine
Auburn, Maine, United States, 04210
United States, North Carolina
Charlotte, North Carolina, United States, 28211
Hickory, North Carolina, United States, 28602
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Surface Logix
  More Information

No publications provided

Responsible Party: Warwick Tong, MB ChB, Surface Logix, Inc.
ClinicalTrials.gov Identifier: NCT00871936     History of Changes
Other Study ID Numbers: SLx-4090-09-07
Study First Received: March 26, 2009
Last Updated: December 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014