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

This study has been completed.
Sponsor:
Information provided by:
InteKrin Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00952445
First received: August 4, 2009
Last updated: August 5, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type II
Drug: T0903131 Besylate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by InteKrin Therapeutics, Inc.:

Enrollment: 70
Study Start Date: December 2003
Study Completion Date: June 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00952445

Locations
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
Endocrine Associates of Dallas
Dallas, Texas, United States
Dallas Diabetes and Endocrine Research Center
Dallas, Texas, United States
Baylor University Endocrine Center
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.
  More Information

No publications provided by InteKrin Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00952445     History of Changes
Other Study ID Numbers: T-131-004
Study First Received: August 4, 2009
Last Updated: August 5, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014