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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Page 1 of 11 (42 locations)

1

Birmingham, Alabama, United States

2

Chandler, Arizona, United States

3

Phoenix, Arizona, United States

4

Tempe, Arizona, United States