Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
NCT ID: NCT00929539
Last Updated: 2013-02-04
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
496 participants
INTERVENTIONAL
2009-06-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose 1 JTT-130
JTT-130
Tablets
Dose 2 JTT-130
JTT-130
Tablets
Dose 3 JTT-130
JTT-130
Tablets
Placebo
JTT-130 Placebo
Tablets
Interventions
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JTT-130
Tablets
JTT-130 Placebo
Tablets
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) of \> 27.0 kg/m2 and ≤ 45.0 kg/m2;
3. 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.
Exclusion Criteria
2. Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
3. Acute coronary syndrome or uncontrolled hypertension;
4. Does not meet medication restriction criteria, as described in the protocol.
18 Years
70 Years
ALL
No
Sponsors
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Akros Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Muscle Shoals, Alabama, United States
Scottsboro, Alabama, United States
Tucson, Arizona, United States
Encino, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Spring Valley, California, United States
Valley Village, California, United States
Walnut Creek, California, United States
Waterbury, Connecticut, United States
Delray Beach, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Sandy Springs, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Erlanger, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Madisonville, Kentucky, United States
Paducah, Kentucky, United States
New Hyde Park, New York, United States
Greensboro, North Carolina, United States
Morehead City, North Carolina, United States
Statesville, North Carolina, United States
Cincinnati, Ohio, United States
Marion, Ohio, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Charleston, South Carolina, United States
Greer, South Carolina, United States
North Charleston, South Carolina, United States
Bristol, Tennessee, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Manassas, Virginia, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Olympia, Washington, United States
Oregon, Wisconsin, United States
Beroun, , Czechia
Brno, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Velké Hoštice, , Czechia
Sátoraljaújhely, , Hungary
Szikszó, , Hungary
Eindhoven, , Netherlands
Groningen, , Netherlands
Arkhangelsk, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Countries
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Other Identifiers
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AT130-G-08-006
Identifier Type: -
Identifier Source: org_study_id
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