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

Completed · 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-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.

Key facts

Study ID

NCT00929539

Run by

Akros Pharma Inc.

People needed

496

Starts

2009-06-01

Expected to finish

2010-07-01

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 > 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Muscle Shoals, Alabama, United States
• Study site — Scottsboro, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Encino, California, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — Spring Valley, California, United States
• Study site — Valley Village, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Delray Beach, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Sandy Springs, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Erlanger, Kentucky, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Madisonville, Kentucky, United States
• Study site — Paducah, Kentucky, United States
• Study site — New Hyde Park, New York, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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