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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:
ClinicalTrials.gov Identifier:
NCT00871936
First Posted: March 30, 2009
Last Update Posted: February 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kadmon Corporation, LLC
  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 Drug: Metformin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Kadmon Corporation, LLC:

Primary Outcome Measures:
  • Reduction in HbA1c [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 12 weeks ]

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 in combination with Metformin
Drug: SLx-4090
SLx-4090
Drug: Metformin
2
Placebo
Other: Placebo
matching tablets
Drug: Metformin

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Kadmon Corporation, LLC
  More Information

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT00871936     History of Changes
Other Study ID Numbers: SLx-4090-09-07
First Submitted: March 26, 2009
First Posted: March 30, 2009
Last Update Posted: February 19, 2015
Last Verified: February 2015

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