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Clinical Trial Details

Trial ID: L6319
Source ID: NCT04450407
Associated Drug: Ly3209590
Title: A Study of LY3209590 in Participants With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04450407/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: LY3209590|DRUG: Insulin Degludec
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c), HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate., Baseline, Week 26 | Secondary: Change From Baseline in Fasting Serum Glucose, LS mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate., Baseline, Week 26|Change From Baseline in Bolus Insulin Dose, Bolus insulin dose was the sum of doses for morning, midday, evening meals, snack and correction. LS mean change from baseline was analysed by MMRM model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline bolus insulin dose as a covariate., Baseline, Week 26|Rate of Documented Hypoglycemia, Documented hypoglycemia is defined as any time a participant reports a self-monitoring blood glucose \<54 mg/dL (3.0 millimole per liter (mmol/L)). Negative binomial model using baseline hypoglycaemia incidence, baseline HbA1c and treatment as independent variables was performed to estimate the event rate. Data presented is group mean. Group Mean is estimated by first taking the inverse link function on individual participant covariates, then averaging over all participants., Baseline through Week 26|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590, AUC of LY3209590 was calculated for individual participants using the participant's Week 26 LY3209590 dose amount and the estimated clearance value., Week 26
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 266
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-07-06
Completion Date: 2021-10-01
Results First Posted: 2022-10-27
Last Update Posted: 2022-10-27
Locations: John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|Valley Endocrine, Fresno, Fresno, California, 93720, United States|Coastal Metabolic Research Centre, Ventura, California, 93003, United States|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States|Denver Endocrinology, Diabetes & Thyroid Center, Englewood, Colorado, 80113, United States|East Coast Institute for Research at The Jones Center, Jacksonville, Florida, 32204, United States|Sun Coast Clinical Research, Inc, New Port Richey, Florida, 34652, United States|Bayside Clinical Research, LLC, New Port Richey, Florida, 34655, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|East Coast Institute for Research at The Jones Center, Macon, Georgia, 31210, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Diabetes and Metabolism Associates, APMC, Metairie, Louisiana, 70006, United States|Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States|Palm Research Center Tenaya, Las Vegas, Nevada, 89128, United States|Southern Nh Diabetes and Endocrinology, Nashua, New Hampshire, 03060, United States|Suny Health Science Center at Syracuse, Syracuse, New York, 13210, United States|Lucas Research, Inc., Morehead City, North Carolina, 28557, United States|PMG Research of Piedmont Healthcare, Statesville, North Carolina, 28625, United States|PMG Research of Wilmington, Wilmington, North Carolina, 28401, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Holston Medical Group, Bristol, Tennessee, 37620, United States|Univ Diab & Endo Consult, Chattanooga, Tennessee, 37411, United States|Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78731-4309, United States|Research Institute of Dallas, Dallas, Texas, 75231, United States|Diabetes and Thyroid Center of Fort Worth, Fort Worth, Texas, 76132, United States|Endocrine and Psychiatry Center, Houston, Texas, 77095, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|Texas Diabetes & Endocrinology, P.A., Round Rock, Texas, 78681, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Universitätsklinikum Graz, Graz, Steiermark, 8036, Austria|Klinik Landstraße, Vienna, 1030, Austria|Zentrum für klinische Studien Dr Hanusch Gmbh, Wien, 1060, Austria|Praxis Dr. Jörg Lüdemann, Falkensee, Brandenburg, 14612, Germany|InnoDiab Forschung Gmbh, Essen, Nordrhein-Westfalen, 45136, Germany|Institut für Diabetesforschung GmbH Münster, Münster, Nordrhein-Westfalen, 48145, Germany|Practice Dr.med. Denger and Dr.med. Pfitzner, Friedrichsthal, Saarland, 66299, Germany|Zentrum für klinische Studien, Saint Ingbert, Saarland, 66386, Germany|SMO.MD GmbH, Magdeburg, Sachsen-Anhalt, 39120, Germany|RED-Institut GmbH, Oldenburg, Schleswig-Holstein, 23758, Germany|Diabeteszentrum Hamburg West, Hamburg, 22607, Germany|Dr Altagracia Aurora Alcantara Gonzalez, Bayamon, 00956, Puerto Rico|Advanced Clinical Research, LLC, Bayamon, 00961, Puerto Rico|Martha Gomez Cuellar M.D., San Juan, 00921, Puerto Rico|Hospital Universitario Virgen de la Victoria, Malaga, Andalucia, 29010, Spain|Hospital Quiron Infanta Luisa, Sevilla, Andalucia, 41010, Spain|Hospital Universitario de La Ribera, Alzira, Valencia, 46600, Spain|Centro Periférico de Especialidades Bola Azul, Almeria, 04009, Spain|Complexo Hospitalario Universitario A Coruña, CHUAC, La Coruña, 15006, Spain|Clínica nuevas Tecnologías en Diabetes y Endocrinología, Sevilla, 41003, Spain|Hospital Universitario Virgen Macarena, Sevilla, 41007, Spain
URL: https://clinicaltrials.gov/show/NCT04450407

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress