Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients With Type 2 Diabetes Mellitus
| Verified date | October 2022 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.
| Status | Completed |
| Enrollment | 278 |
| Est. completion date | October 8, 2021 |
| Est. primary completion date | October 8, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening - Participants must have a HbA1c value of 7.0% to 9.5%, inclusive - Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive Exclusion Criteria: - Have type 1 diabetes mellitus or latent autoimmune diabetes - Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening - Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke) - Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease - Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m² - Have active or untreated cancer - Are receiving chronic (>14 days) systemic glucocorticoid therapy |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Asociación de Beneficencia Hospital Sirio Libanés | Buenos Aires | |
| Argentina | CEMEDIC | Buenos Aires | |
| Argentina | CEDIC | Caba | Buenos Aires |
| Argentina | Centro Médico Viamonte | Caba | Buenos Aires |
| Argentina | Consultorio de Investigación Clínica EMO SRL | Caba | Buenos Aires |
| Argentina | Fundacion Sanatorio Guemes | Caba | Buenos Aires |
| Argentina | Investigaciones Medicas Imoba Srl | Caba | Buenos Aires |
| Argentina | Instituto Centenario | Ciudad Autonoma de Buenos Aire | |
| Argentina | Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC | Cordoba | |
| Argentina | Instituto Médico Catamarca | Rosario | Santa Fe |
| Argentina | Clínica Mayo | Tucuman | |
| Germany | Diabetes- und Stoffwechselpraxis Bochum | Bochum | Nordrhein-Westfalen |
| Germany | InnoDiab Forschung Gmbh | Essen | Nordrhein-Westfalen |
| Germany | Practice Dr.med. Denger and Dr.med. Pfitzner | Friedrichsthal | Saarland |
| Germany | Diabeteszentrum Hamburg West | Hamburg | |
| Germany | SMO.MD GmbH | Magdeburg | Sachsen-Anhalt |
| Germany | Institut für Diabetesforschung GmbH Münster | Münster | Nordrhein-Westfalen |
| Germany | RED-Institut GmbH | Oldenburg | Schleswig-Holstein |
| Germany | Private Practice - Dr. Christine Kosch | Pirna | Sachsen |
| Poland | Centrum Kliniczno-Badawcze | Elblag | |
| Poland | Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomorskie |
| Poland | Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET | Krakow | Malopolskie |
| Poland | Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | |
| Poland | Gabinety TERPA | Lublin | |
| Poland | OMEDICA Medical Center | Poznan | |
| Poland | Praktyka Lekarska | Poznan | |
| Poland | NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki | Ruda Slaska | Slaskie |
| Poland | Instytut Diabetologii Sp. z o.o | Warsaw | Masovian |
| Poland | Poradnia Chorob Metabolicznych | Wierzchoslawice | |
| Poland | NZOZ Regionalna Poradnia Diabetologiczna | Wroclaw | |
| Puerto Rico | Research and Cardiovascular Corp. | Ponce | |
| Puerto Rico | GCM Medical Group, PSC - Hato Rey Site | San Juan | |
| Puerto Rico | Centro Profesional de Endocrinologia del Este | Yabucoa | |
| United States | Texas Diabetes & Endocrinology, P.A. | Austin | Texas |
| United States | Elite Clinical Trials | Blackfoot | Idaho |
| United States | Holston Medical Group | Bristol | Tennessee |
| United States | ALL Medical Research, LLC | Cooper City | Florida |
| United States | Dallas Diabetes Research Center | Dallas | Texas |
| United States | Lillestol Research LLC | Fargo | North Dakota |
| United States | Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care | Fort Lauderdale | Florida |
| United States | Juno Research | Houston | Texas |
| United States | Juno Research - Gessner | Houston | Texas |
| United States | National Research Institute - Huntington Park | Huntington Park | California |
| United States | Rocky Mountain Clinical Research | Idaho Falls | Idaho |
| United States | National Research Institute - Wilshire | Los Angeles | California |
| United States | L-MARC Research Center | Louisville | Kentucky |
| United States | Southern Endocrinology Associates | Mesquite | Texas |
| United States | New Horizon Research Center | Miami | Florida |
| United States | Suncoast Research Group | Miami | Florida |
| United States | Catalina Research Institute, LLC | Montclair | California |
| United States | Suncoast Clinical Research | New Port Richey | Florida |
| United States | Intend Research, LLC | Norman | Oklahoma |
| United States | Rainier Clinical Research Center | Renton | Washington |
| United States | Elite Clinical Trials | Rexburg | Idaho |
| United States | Sky Clin Resch - Quinn HC | Ridgeland | Mississippi |
| United States | Endocrine and Metabolic Consultants | Rockville | Maryland |
| United States | Consano Clinical Research, LLC | Shavano Park | Texas |
| United States | Syed Research Consultants Llc | Sheffield | Alabama |
| United States | Encompass Clinical Research | Spring Valley | California |
| United States | Cotton O'Neil Diabetes and Endocrinology Center | Topeka | Kansas |
| United States | Rophe Adult and Pediatric Medicine | Union City | Georgia |
| United States | Preferred Primary Care Physicians | Uniontown | Pennsylvania |
| United States | CMR of Greater New Haven | Waterbury | Connecticut |
| United States | Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Argentina, Germany, Poland, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | |
| Secondary | 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 | |
| Secondary | 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 |
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