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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

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
GroupInterventionDescription
PlaceboPlaceboOnce daily, oral
T0903131 BesylateT0903131 Besylate1.0 mg
T0903131 Besylate (higher dose)T0903131 Besylate10.0 mg
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (18)

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

🇺🇸

Anderson, South Carolina, United States

St Louis Center for Clinical Research

🇺🇸

Saint Louis, Missouri, United States

Kaleida Health Diabetes Center

🇺🇸

Buffalo, New York, United States

Scroll for more (8 remaining)
Whittier Diabetes Institute
🇺🇸La Jolla, California, United States

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