Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in 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 ≤ 45.0 kg/m2;

3. Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding;

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

3. Acute coronary syndrome or uncontrolled hypertension;

4. Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.