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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type II
• Interventions: Drug: Placebo; Drug: T0903131 Besylate

• Registration Number: NCT00952445
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study Completion: 2004-06
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Once daily, oral
T0903131 Besylate	T0903131 Besylate	1.0 mg
T0903131 Besylate (higher dose)	T0903131 Besylate	10.0 mg

Trial Locations

Locations (18)

University of Miami; 🇺🇸 Miami, Florida, United States

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States

St Louis Center for Clinical Research; 🇺🇸 Saint Louis, Missouri, United States

Dallas Diabetes and Endocrine Research Center; 🇺🇸 Dallas, Texas, United States

Endocrine Associates of Dallas; 🇺🇸 Dallas, Texas, United States

Whittier Diabetes Institute; 🇺🇸 La Jolla, California, United States

Charles R. Drew University; 🇺🇸 Los Angeles, California, United States

GFI Research Center; 🇺🇸 Evansville, Indiana, United States

Lovelace Research Institute; 🇺🇸 Santa Ana, California, United States

National Research Institute; 🇺🇸 Los Angeles, California, United States

Rochester Clinical Research; 🇺🇸 Rochester, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Kaleida Health Diabetes Center; 🇺🇸 Buffalo, New York, United States

Baylor University Endocrine Center; 🇺🇸 Dallas, Texas, United States

Endocrine Research Specialists; 🇺🇸 Ogden, Utah, United States

Salem VA Medical Center; 🇺🇸 Salem, Virginia, United States

Diabetes and Grandular Disease Clinic and Reseach Center; 🇺🇸 San Antonio, Texas, United States

Radiant Research; 🇺🇸 Anderson, South Carolina, United States