Status:
COMPLETED
Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
Lead Sponsor:
Akros Pharma Inc.
Conditions:
Type II Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Have type 2 diabetes;
- Body mass index (BMI) of \> 27.0 kg/m2 and ≤ 45.0 kg/m2;
- 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
- Females who are pregnant or breast-feeding
- Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- Acute coronary syndrome or uncontrolled hypertension;
- Does not meet medication restriction criteria, as described in the protocol.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT00929539
Start Date
June 1 2009
End Date
July 1 2010
Last Update
February 4 2013
Active Locations (62)
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1
Birmingham, Alabama, United States
2
Muscle Shoals, Alabama, United States
3
Scottsboro, Alabama, United States
4
Tucson, Arizona, United States