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

Diabetes Mellitus, Type II Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952445
• Other study ID #: T-131-004
• Status: Completed
• Phase: Phase 2
• Start date: December 2003
• Est. completion date: June 2004

Study information

• Verified date: October 2022
• Source: InteKrin Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• T0903131 Besylate
Once daily, oral
• Placebo
Once daily, oral

Locations

Country	Name	City	State
United States	Radiant Research	Anderson	South Carolina
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Kaleida Health Diabetes Center	Buffalo	New York
United States	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	Duke University Medical Center	Durham	North Carolina
United States	Radiant Research	Edina	Minnesota
United States	GFI Research Center	Evansville	Indiana
United States	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	University of Miami	Miami	Florida
United States	Endocrine Research Specialists	Ogden	Utah
United States	Radiant Research	Portland	Oregon
United States	Rochester Clinical Research	Rochester	New York
United States	Radiant Research	Saint Louis	Missouri
United States	St Louis Center for Clinical Research	Saint Louis	Missouri
United States	Salem VA Medical Center	Salem	Virginia
United States	Diabetes and Grandular Disease Clinic and Reseach Center	San Antonio	Texas
United States	Lovelace Research Institute	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
InteKrin Therapeutics, Inc.

Country where clinical trial is conducted

United States,