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Clinical Trial Details

Trial ID: L2474
Source ID: NCT04450394
Associated Drug: Ly3209590
Title: A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04450394/results
Conditions: Type 2 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, Dipeptidyl peptidase IV (DPPIV) (yes/no), Sodium-glucose Cotransporter-2 (SGLT2) (yes/no), baseline body mass index (BMI) \[\<30, \>=30\]), 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 MMRM model with treatment, country, DPPIV (yes/no), SGLT2 (yes/no), baseline BMI \[\<30, \>=30\]), visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose 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)). Rate of documented hypoglycemia per year during defined period is calculated by the number of documented hypoglycemia events within the period divided by the number of days participant at risk within the period\*365.25 days., 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 participants' Week 26 LY3209590 dose amount and estimated clearance value., Week 26
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 278
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-07-01
Completion Date: 2021-10-08
Results First Posted: 2022-11-02
Last Update Posted: 2022-11-02
Locations: Syed Research Consultants Llc, Sheffield, Alabama, 35660, United States|National Research Institute - Huntington Park, Huntington Park, California, 90255, United States|National Research Institute - Wilshire, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|CMR of Greater New Haven, Waterbury, Connecticut, 06708, United States|ALL Medical Research, LLC, Cooper City, Florida, 33024, United States|Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care, Fort Lauderdale, Florida, 33312, United States|Suncoast Research Group, Miami, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33165 3338, United States|Suncoast Clinical Research, New Port Richey, Florida, 34652, United States|Rophe Adult and Pediatric Medicine, Union City, Georgia, 30291, United States|Elite Clinical Trials, Blackfoot, Idaho, 83221, United States|Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States|Elite Clinical Trials, Rexburg, Idaho, 83440, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Cotton O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, 66606, United States|L-MARC Research Center, Louisville, Kentucky, 40213, United States|Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States|Sky Clin Resch - Quinn HC, Ridgeland, Mississippi, 39157, United States|Lillestol Research LLC, Fargo, North Dakota, 58104, United States|Intend Research, LLC, Norman, Oklahoma, 73069, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Holston Medical Group, Bristol, Tennessee, 37620, United States|Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78731-4309, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Juno Research, Houston, Texas, 77040, United States|Juno Research - Gessner, Houston, Texas, 77074, United States|Southern Endocrinology Associates, Mesquite, Texas, 75149, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Centro Médico Viamonte, Caba, Buenos Aires, C1120AAC, Argentina|Investigaciones Medicas Imoba Srl, Caba, Buenos Aires, C1179AAB, Argentina|Fundacion Sanatorio Guemes, Caba, Buenos Aires, C1180AAX, Argentina|Consultorio de Investigación Clínica EMO SRL, Caba, Buenos Aires, C1405BUB, Argentina|CEDIC, Caba, Buenos Aires, C1425DES, Argentina|Instituto Médico Catamarca, Rosario, Santa Fe, 2000, Argentina|CEMEDIC, Buenos Aires, 1407, Argentina|Asociación de Beneficencia Hospital Sirio Libanés, Buenos Aires, C1419AHN, Argentina|Instituto Centenario, Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina|Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC, Cordoba, X5008HHW, Argentina|Clínica Mayo, Tucuman, T4000IHE, Argentina|Diabetes- und Stoffwechselpraxis Bochum, Bochum, Nordrhein-Westfalen, 44869, 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|SMO.MD GmbH, Magdeburg, Sachsen-Anhalt, 39120, Germany|Private Practice - Dr. Christine Kosch, Pirna, Sachsen, 01796, Germany|RED-Institut GmbH, Oldenburg, Schleswig-Holstein, 23758, Germany|Diabeteszentrum Hamburg West, Hamburg, 22607, Germany|Instytut Diabetologii Sp. z o.o, Warsaw, Masovian, 02-117, Poland|Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET, Krakow, Małopolskie, 31-261, Poland|Centrum Badan Klinicznych PI-House sp. z o.o., Gdansk, Pomorskie, 80-546, Poland|NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki, Ruda Slaska, Slaskie, 41-709, Poland|Centrum Kliniczno-Badawcze, Elblag, 82-300, Poland|Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna, Lodz, 90242, Poland|Gabinety TERPA, Lublin, 20-333, Poland|OMEDICA Medical Center, Poznan, 60-111, Poland|Praktyka Lekarska, Poznan, 61-655, Poland|Poradnia Chorob Metabolicznych, Wierzchosławice, 33-122, Poland|NZOZ Regionalna Poradnia Diabetologiczna, Wroclaw, 50-127, Poland|Research and Cardiovascular Corp., Ponce, 00717, Puerto Rico|GCM Medical Group, PSC - Hato Rey Site, San Juan, 00917, Puerto Rico|Centro Profesional de Endocrinologia del Este, Yabucoa, 00767, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT04450394

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress