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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type II

In brief

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.

Key facts

Study ID

NCT00952445

Run by

InteKrin Therapeutics, Inc.

People needed

70

Starts

2003-12-01

Expected to finish

2004-06-01

Last updated by the study team

2022-10-19

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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