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

InteKrin Therapeutics

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type II

Treatments: Drug: Placebo; Drug: T0903131 Besylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00952445

T-131-004

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 3 patient groups, including a placebo group

T0903131 Besylate

Experimental group

Description:

1.0 mg

Treatment:

Drug: T0903131 Besylate

T0903131 Besylate (higher dose)

Experimental group

Description:

10.0 mg

Treatment:

Drug: T0903131 Besylate

Placebo

Placebo Comparator group

Description:

Once daily, oral

Treatment:

Drug: Placebo