Diabetes Mellitus, Type II
Conditions
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.
Interventions
DRUGT0903131 Besylate
Once daily, oral
DRUGPlacebo
Once daily, oral
Sponsors
InteKrin Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed