Status:
TERMINATED
Efficacy and Safety Study of JTT-654 in 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-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.
Eligibility Criteria
Inclusion
- Have type 2 diabetes;
- Body mass index (BMI) of ≤ 45.0 kg/m2;
- Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.
Exclusion
- Females who are pregnant or breast-feeding;
- 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;
- Acute coronary syndrome or uncontrolled hypertension;
- Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00997152
Start Date
September 1 2009
End Date
April 1 2010
Last Update
February 4 2013
Active Locations (42)
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1
Birmingham, Alabama, United States
2
Chandler, Arizona, United States
3
Phoenix, Arizona, United States
4
Tempe, Arizona, United States