Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Type II Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00997152

Run by

Akros Pharma Inc.

People needed

152

Starts

2009-09-01

Expected to finish

2010-04-01

Last updated by the study team

2013-02-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Chino, California, United States
• Study site — Greenbrae, California, United States
• Study site — Huntington Park, California, United States
• Study site — Los Angeles, California, United States
• Study site — Paramount, California, United States
• Study site — Sacramento, California, United States
• Study site — Walnut Creek, California, United States
• Study site — West Covina, California, United States
• Study site — DeLand, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Addison, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Oxon Hill, Maryland, United States
• Study site — New Bedford, Massachusetts, United States
• Study site — Great Falls, Montana, United States

Full record on ClinicalTrials.gov

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