Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

Key facts

Study ID

NCT01699737

Run by

Akros Pharma Inc.

People needed

325

Starts

2012-09-01

Expected to finish

2013-07-01

Last updated by the study team

2013-08-01

Who can join

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

You may qualify if…

• Males and females with type 2 diabetes, 18-70 years of age at Visit 1
• Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
• Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
• Body mass index (BMI) ≥ 23.0 kg/m\^2 and ≤ 45.0 kg/m\^2 at Visit 1

You may not qualify if…

• Females who are pregnant or breast-feeding
• Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
• Acute coronary syndrome or uncontrolled hypertension
• Does not meet all diet or previous/concomitant medication restriction criteria

Where it is running

• Study site — Dothan, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Muscle Shoals, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Artesia, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Buena Park, California, United States
• Study site — Chino, California, United States
• Study site — Garden Grove, California, United States
• Study site — Lincoln, California, United States
• Study site — Lomita, California, United States
• Study site — Los Angeles, California, United States
• Study site — Newport Beach, California, United States
• Study site — North Hollywood, California, United States
• Study site — Paramount, California, United States
• Study site — Sacramento, California, United States
• Study site — Spring Valley, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Denver, Colorado, United States
• Study site — Cooper City, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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