Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.

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

Details

• Lead Sponsor: Akros Pharma Inc.

Criteria

Inclusion Criteria:

1. Have type 2 diabetes;

2. Body mass index (BMI) of > 27.0 kg/m2 and ≤ 45.0 kg/m2;

3. Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding

2. Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;

3. Acute coronary syndrome or uncontrolled hypertension;

4. Does not meet medication restriction criteria, as described in the protocol.