Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01699737
Last Updated: 2013-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
325 participants
INTERVENTIONAL
2012-09-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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JTT-851 Dose 1
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
JTT-851
Placebo for comparator
JTT-851 Dose 2
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
JTT-851
Placebo for comparator
JTT-851 Dose 3
JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
JTT-851
Placebo for comparator
Glimepiride Dose 1
Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
Glimepiride
Encapsulated Glimepiride tablets
Placebo for Active
Placebo active & Placebo comparator
Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks
Placebo for Active
Placebo for comparator
Interventions
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JTT-851
Glimepiride
Encapsulated Glimepiride tablets
Placebo for Active
Placebo for comparator
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Akros Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hisashi Kodama, Ph.D.
Role: STUDY_CHAIR
Akros Pharma Inc.
Locations
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Birmingham, Alabama, United States
Dothan, Alabama, United States
Huntsville, Alabama, United States
Montgomery, Alabama, United States
Muscle Shoals, Alabama, United States
Glendale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Artesia, California, United States
Beverly Hills, California, United States
Buena Park, California, United States
Chino, California, United States
Garden Grove, California, United States
Lincoln, California, United States
Lomita, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
North Hollywood, California, United States
Paramount, California, United States
Sacramento, California, United States
Spring Valley, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Cooper City, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Kissimee, Florida, United States
Miami, Florida, United States
Miramar, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Pembroke Pines, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Columbus, Georgia, United States
Marietta, Georgia, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Lake Charles, Louisiana, United States
New Orleans, Louisiana, United States
Oxon Hill, Maryland, United States
Olive Branch, Mississippi, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Mine Hill, New Jersey, United States
Glen Falls, New York, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Kettering, Ohio, United States
Marion, Ohio, United States
Munroe Falls, Ohio, United States
Wadsworth, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Lansdale, Pennsylvania, United States
Columbia, South Carolina, United States
Greer, South Carolina, United States
Carrollton, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Sugarland, Texas, United States
Tomball, Texas, United States
Murray, Utah, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
Burke, Virginia, United States
Manassas, Virginia, United States
Norfolk, Virginia, United States
Suffolk, Virginia, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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AT851-U-12-002
Identifier Type: -
Identifier Source: org_study_id