Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

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

Details

• Lead Sponsor: Akros Pharma Inc.
• Treatments: Glimepiride

Criteria

Inclusion Criteria:

• Males and females with type 2 diabetes, 18-70 years of age at Visit 1

• Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)

• Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment

• Body mass index (BMI) ≥ 23.0 kg/m^2 and ≤ 45.0 kg/m^2 at Visit 1

Exclusion Criteria:

• Females who are pregnant or breast-feeding

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

• Acute coronary syndrome or uncontrolled hypertension

• Does not meet all diet or previous/concomitant medication restriction criteria