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Clinical Trial Details

Trial ID: L4787
Source ID: NCT01794143
Associated Drug: Sulfonylurea (Glimepiride)
Title: A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes
Acronym: GRADE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Comparative Effectiveness of Glycemia-lowering Medications
Interventions: DRUG: Sulfonylurea (glimepiride)|DRUG: DPP-4 inhibitor (sitagliptin)|DRUG: GLP-1 receptor agonist (liraglutide)|DRUG: Insulin (glargine)
Outcome Measures: Primary: Time to HbA1c>=7%, while receiving metformin and the randomly assigned study medication, The primary metabolic outcome is the time to primary failure defined as an HbA1c\>=7% (53mmol/mol), subsequently confirmed., Quarterly for 4 to 7 years | Secondary: Time to HbA1c>7.5%, while receiving metformin and the randomly assigned study medication., The secondary metabolic outcome is time to HbA1c\>7.5% (58 mmol/mol), confirmed., Quarterly for 4 to 7 years | Other: Time to HbA1c>7.5%, while receiving study medications and basal insulin, The tertially metabolic outcome is the time to a HbA1c\>7.5% (58 mmol/mol), confirmed, while receiving metformin, the originally assigned medication and basal insulin., Quarterly for 4 to 7 years
Sponsor/Collaborators: Sponsor: GRADE Study Group | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|National Heart, Lung, and Blood Institute (NHLBI)|Becton, Dickinson and Company|Bristol-Myers Squibb|Merck Sharp & Dohme LLC|Novo Nordisk A/S|Roche Diagnostics GmbH|Sanofi|Centers for Disease Control and Prevention
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 5047
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-05
Completion Date:
Results First Posted:
Last Update Posted: 2022-04-14
Locations: University of Alabama-Birmingham, Birmingham, Alabama, United States|Southwestern American Indian Center, Phoenix, Arizona, United States|Veterans Medical Research Foundation, San Diego (San Diego VA), San Diego, California, United States|University of Colorado, Denver, Colorado, United States|Yale University School of Medicine, New Haven, Connecticut, United States|South Florida VA Foundation (Miami VA), Miami, Florida, United States|Atlanta VA Medical Center, Decatur, Georgia, United States|Kaiser Permanente of Georgia, Duluth, Georgia, United States|Pacific Health Research and Education Institute (VA Pacific Islands), Honolulu, Hawaii, United States|Indiana University School of Medicine, Indianapolis, Indiana, United States|University of Iowa, Iowa City, Iowa, United States|Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States|MedStar Health Research Institute, Hyattsville, Maryland, United States|Massachusetts General Hospital, Boston, Massachusetts, United States|University of Michigan, Ann Arbor, Michigan, United States|International Diabetes Center, Minneapolis, Minnesota, United States|University of Minnesota, Minneapolis, Minnesota, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|University of Nebraska, Omaha, Nebraska, United States|University of New Mexico School of Medicine, Albuquerque, New Mexico, United States|Albert Einstein College of Medicine, Bronx, New York, United States|State University of New York (SUNY)-Downstate Medical Center, Brooklyn, New York, United States|Columbia University Naomi Berrie Diabetes Center, New York, New York, United States|Mount Sinai St. Luke's Hospital, New York, New York, United States|Duke University Medical Center, Durham, North Carolina, United States|University of North Carolina Diabetes Care Center, Durham, North Carolina, United States|University of Cincinnati, Cincinnati, Ohio, United States|Case Western Reserve University School of Medicine, Cleveland, Ohio, United States|Kaiser Permanente Northwest, Portland, Oregon, United States|Oregon Health and Science University, Portland, Oregon, United States|Vanderbilt University Medical Center, Nashville, Tennessee, United States|Baylor Endocrine Center, Dallas, Texas, United States|University of Texas-Southwestern Medical Center, Dallas, Texas, United States|Baylor College of Medicine, Houston, Texas, United States|University of Texas Health Science Center, San Antonio, Texas, United States|Seattle Institute for Biomedical and Clinical Research, Seattle, Washington, United States
URL: https://clinicaltrials.gov/show/NCT01794143

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress