A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus

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. Identifier: NCT00952445
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 6, 2009
Information provided by:
InteKrin Therapeutics, Inc.

Brief Summary:
The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Drug: T0903131 Besylate Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus
Study Start Date : December 2003
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: T0903131 Besylate
1.0 mg
Drug: T0903131 Besylate
Once daily, oral
Other Name: INT131 Besylate
Experimental: T0903131 Besylate
10.0 mg
Drug: T0903131 Besylate
Once daily, oral
Other Name: INT131 Besylate
Placebo Comparator: Placebo
Once daily, oral
Drug: Placebo
Once daily, oral

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment
  • Fasting Plasma Glucose between 126 and 240 mg/dL
  • Hemoglobin-A1c (HbA1c) between 6.8% and 10.0%
  • Fasting C-peptide > 0.8 ng/mL

Exclusion Criteria:

  • Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening
  • Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone
  • BMI > 42 kg/m2
  • Presence of any diabetic complications requiring chronic therapy
  • Presence or history of any form of hepatic disease
  • Serum creatinine > 1.8 mg/dL
  • History of cardiac arrhythmias or abnormal cardiac electrophysiology
  • Any reason that, in the Investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol

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 identifier (NCT number): NCT00952445

United States, California
Whittier Diabetes Institute
La Jolla, California, United States
Charles R. Drew University
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
Lovelace Research Institute
Santa Ana, California, United States
United States, Florida
University of Miami
Miami, Florida, United States
United States, Indiana
GFI Research Center
Evansville, Indiana, United States
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States
United States, Minnesota
Radiant Research
Edina, Minnesota, United States
United States, Missouri
Radiant Research
St. Louis, Missouri, United States
St Louis Center for Clinical Research
St. Louis, Missouri, United States
United States, New York
Kaleida Health Diabetes Center
Buffalo, New York, United States
Rochester Clinical Research
Rochester, New York, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Oregon
Radiant Research
Portland, Oregon, United States
United States, South Carolina
Radiant Research
Anderson, South Carolina, United States
United States, Texas
Baylor University Endocrine Center
Dallas, Texas, United States
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, United States
Endocrine Associates of Dallas
Dallas, Texas, United States
Diabetes and Grandular Disease Clinic and Reseach Center
San Antonio, Texas, United States
United States, Utah
Endocrine Research Specialists
Ogden, Utah, United States
United States, Virginia
Salem VA Medical Center
Salem, Virginia, United States
Sponsors and Collaborators
InteKrin Therapeutics, Inc.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00952445     History of Changes
Other Study ID Numbers: T-131-004
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases