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

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InteKrin Therapeutics, Inc.

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