Status:
COMPLETED
A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus
Lead Sponsor:
InteKrin Therapeutics, Inc.
Conditions:
Diabetes Mellitus, Type II
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00952445
Start Date
December 1 2003
End Date
June 1 2004
Last Update
October 19 2022
Active Locations (21)
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1
Whittier Diabetes Institute
La Jolla, California, United States
2
Charles R. Drew University
Los Angeles, California, United States
3
National Research Institute
Los Angeles, California, United States
4
Lovelace Research Institute
Santa Ana, California, United States