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Clinical Trial Details

Trial ID: L5753
Source ID: NCT01699737
Associated Drug: Jtt-851
Title: Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: JTT-851|DRUG: Glimepiride|DRUG: Placebo for Active|DRUG: Placebo for comparator
Outcome Measures: Primary: Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851, To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks, 12 weeks | Secondary: Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo, To evaluate the safety and tolerability of JTT-851 when administered for 12 weeks in patients with type 2 diabetes compared to glimepiride and placebo., 12 weeks|Effect on ancillary efficacy measures, To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo., 12 weeks|Pharmacokinetics of JTT-851 and its metabolites, To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes, 12 weeks | Other: Relationship between dose and response of JTT-851, To explore the relationship between the JTT-851 dose (exposure) and response, 12 weeks
Sponsor/Collaborators: Sponsor: Akros Pharma Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 325
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-09
Completion Date: 2013-07
Results First Posted:
Last Update Posted: 2013-08-01
Locations: 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|Ft. 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
URL: https://clinicaltrials.gov/show/NCT01699737

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress