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

Phase 2

Completed

• Conditions: Type II Diabetes Mellitus
• Interventions: Drug: JTT-130; Drug: JTT-130 Placebo

• Registration Number: NCT00929539
• Lead Sponsor: Akros Pharma Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Primary Completion: 2010-05
• Study Completion: 2010-07
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-31
• Disposition First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Disposition First Posted: 2013-02-04
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 496

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1 JTT-130	JTT-130	-
Placebo	JTT-130 Placebo	-
Dose 2 JTT-130	JTT-130	-
Dose 3 JTT-130	JTT-130	-

Primary Outcome Measures

Name	Time	Method
Change in glycosylated hemoglobin (HbA1c) levels	End of Study

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability data	End of Study