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Clinical Trial Details

Trial ID: L5253
Source ID: NCT01169090
Associated Drug: Sk-0403
Title: A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: SK-0403|DRUG: Placebo|DRUG: Sitagliptin
Outcome Measures: Primary: Change in HbA1c from baseline to Week 16., Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF)., Baseline, 16 weeks | Secondary: Change from baseline in Fasting Plasma Glucose (FPG), Baseline, 16 weeks
Sponsor/Collaborators: Sponsor: Kowa Research Institute, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 620
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-07
Completion Date: 2011-08
Results First Posted:
Last Update Posted: 2011-08-17
Locations: Birmingham, Alabama, United States|Huntsville, Alabama, United States|Muscle Shoals, Alabama, United States|Phoenix, Arizona, United States|Encinitas, California, United States|Huntington Park, California, United States|Los Angeles, California, United States|San Mateo, California, United States|Spring Valley, California, United States|Walnut Creek, California, United States|Miami, Florida, United States|Palm Harbour, Florida, United States|Pembroke Pines, Florida, United States|Honolulu, Hawaii, United States|Chicago, Illinois, United States|Indianapolis, Indiana, United States|Lexington, Kentucky, United States|Paducah, Kentucky, United States|New Orleans, Louisiana, United States|St. Paul, Minnesota, United States|Charlotte, North Carolina, United States|Greenville, North Carolina, United States|Statesville, North Carolina, United States|Cincinnati, Ohio, United States|Marion, Ohio, United States|Mount Giliad, Ohio, United States|Oklahoma City, Oklahoma, United States|Eugene, Oregon, United States|Portland, Oregon, United States|Beaver, Pennsylvania, United States|Charleston, South Carolina, United States|Greensboro, South Carolina, 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|Sandy, Utah, United States|Norfolk, Virginia, United States|Richmond, Virginia, United States
URL: https://clinicaltrials.gov/show/NCT01169090

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress