A Study of LY3209590 in Participants With Type 1 Diabetes
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Registration Number
- NCT04450407
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 266
- Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year
- Participants must have been using multiple daily injections without interruption for at least 3 months
- Participants must have HbA1c values of 5.6% to 9.5%, inclusive
- Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²)
- Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3209590 Algorithm 1 (Paper) LY3209590 Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 milligrams per deciliter (mg/dL). LY3209590 Algorithm 2 (Digital) LY3209590 Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL. As per protocol amendment (d) approved on 28-Oct-2020, this arm was terminated during the early enrollment phase due to technical issues with data entry. Insulin Degludec Insulin Degludec Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 26 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Fasting Serum Glucose Baseline, Week 26 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.
Change From Baseline in Bolus Insulin Dose Baseline, Week 26 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.
Rate of Documented Hypoglycemia Baseline through Week 26 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.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 Week 26 AUC of LY3209590 was calculated for individual participants using the participant's Week 26 LY3209590 dose amount and the estimated clearance value.
Trial Locations
- Locations (52)
Klinik Landstraße
🇦🇹Vienna, Austria
Diabetes and Thyroid Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Centro Periférico de Especialidades Bola Azul
🇪🇸Almeria, Spain
Sun Coast Clinical Research, Inc
🇺🇸New Port Richey, Florida, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Clínica nuevas Tecnologías en Diabetes y Endocrinología
🇪🇸Sevilla, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucia, Spain
Zentrum für klinische Studien
🇩🇪Saint Ingbert, Saarland, Germany
Zentrum für klinische Studien Dr Hanusch Gmbh
🇦🇹Wien, Austria
Bayside Clinical Research, LLC
🇺🇸New Port Richey, Florida, United States
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
Complexo Hospitalario Universitario A Coruña, CHUAC
🇪🇸La Coruña, Spain
Hospital Universitario de La Ribera
🇪🇸Alzira, Valencia, Spain
Praxis Dr. Jörg Lüdemann
🇩🇪Falkensee, Brandenburg, Germany
Holston Medical Group
🇺🇸Bristol, Tennessee, United States
Universitätsklinikum Graz
🇦🇹Graz, Steiermark, Austria
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Diabeteszentrum Hamburg West
🇩🇪Hamburg, Germany
Hospital Quiron Infanta Luisa
🇪🇸Sevilla, Andalucia, Spain
Institut für Diabetesforschung GmbH Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Dr Altagracia Aurora Alcantara Gonzalez
🇵🇷Bayamon, Puerto Rico
Denver Endocrinology, Diabetes & Thyroid Center
🇺🇸Englewood, Colorado, United States
East Coast Institute for Research at The Jones Center
🇺🇸Macon, Georgia, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
Suny Health Science Center at Syracuse
🇺🇸Syracuse, New York, United States
PMG Research of Piedmont Healthcare
🇺🇸Statesville, North Carolina, United States
Intend Research, LLC
🇺🇸Norman, Oklahoma, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Round Rock, Texas, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Endocrine and Psychiatry Center
🇺🇸Houston, Texas, United States
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
Practice Dr.med. Denger and Dr.med. Pfitzner
🇩🇪Friedrichsthal, Saarland, Germany
Barbara Davis Center for Childhood Diabetes
🇺🇸Aurora, Colorado, United States
Coastal Metabolic Research Centre
🇺🇸Ventura, California, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
Diabetes and Metabolism Associates, APMC
🇺🇸Metairie, Louisiana, United States
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
Lucas Research, Inc.
🇺🇸Morehead City, North Carolina, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Univ Diab & Endo Consult
🇺🇸Chattanooga, Tennessee, United States
Advanced Clinical Research, LLC
🇵🇷Bayamon, Puerto Rico
Valley Endocrine, Fresno
🇺🇸Fresno, California, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Southern Nh Diabetes and Endocrinology
🇺🇸Nashua, New Hampshire, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
InnoDiab Forschung Gmbh
🇩🇪Essen, Nordrhein-Westfalen, Germany
SMO.MD GmbH
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Martha Gomez Cuellar M.D.
🇵🇷San Juan, Puerto Rico