A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT04450394
- 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 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
- 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
- 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
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 baseline median fasting glucose and body weight 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 baseline median fasting glucose and body weight 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 of 10 units, 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, 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Fasting Serum Glucose Baseline, Week 26 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.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 Week 26 AUC of LY3209590 was calculated for individual participants using the participants' Week 26 LY3209590 dose amount and estimated clearance value.
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)). 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.
Trial Locations
- Locations (63)
CEMEDIC
🇦🇷Buenos Aires, Argentina
Centrum Kliniczno-Badawcze
🇵🇱Elblag, Poland
Gabinety TERPA
🇵🇱Lublin, Poland
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
ALL Medical Research, LLC
🇺🇸Cooper City, Florida, United States
Rophe Adult and Pediatric Medicine
🇺🇸Union City, Georgia, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Sky Clin Resch - Quinn HC
🇺🇸Ridgeland, Mississippi, United States
Juno Research - Gessner
🇺🇸Houston, Texas, United States
Clínica Mayo
🇦🇷Tucuman, Argentina
Private Practice - Dr. Christine Kosch
🇩🇪Pirna, Sachsen, Germany
NZOZ Regionalna Poradnia Diabetologiczna
🇵🇱Wroclaw, Poland
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Practice Dr.med. Denger and Dr.med. Pfitzner
🇩🇪Friedrichsthal, Saarland, Germany
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
Cotton O'Neil Diabetes and Endocrinology Center
🇺🇸Topeka, Kansas, United States
National Research Institute - Huntington Park
🇺🇸Huntington Park, California, United States
Syed Research Consultants Llc
🇺🇸Sheffield, Alabama, United States
National Research Institute - Wilshire
🇺🇸Los Angeles, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
CMR of Greater New Haven
🇺🇸Waterbury, Connecticut, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
🇺🇸Fort Lauderdale, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Elite Clinical Trials
🇺🇸Rexburg, Idaho, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
Intend Research, LLC
🇺🇸Norman, Oklahoma, United States
Holston Medical Group
🇺🇸Bristol, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Austin, Texas, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Centro Médico Viamonte
🇦🇷Caba, Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl
🇦🇷Caba, Buenos Aires, Argentina
Fundacion Sanatorio Guemes
🇦🇷Caba, Buenos Aires, Argentina
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Consultorio de Investigación Clínica EMO SRL
🇦🇷Caba, Buenos Aires, Argentina
CEDIC
🇦🇷Caba, Buenos Aires, Argentina
Instituto Médico Catamarca
🇦🇷Rosario, Santa Fe, Argentina
Diabetes- und Stoffwechselpraxis Bochum
🇩🇪Bochum, Nordrhein-Westfalen, Germany
Instituto Centenario
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Asociación de Beneficencia Hospital Sirio Libanés
🇦🇷Buenos Aires, Argentina
InnoDiab Forschung Gmbh
🇩🇪Essen, Nordrhein-Westfalen, Germany
Institut für Diabetesforschung GmbH Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
SMO.MD GmbH
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Instytut Diabetologii Sp. z o.o
🇵🇱Warsaw, Masovian, Poland
Diabeteszentrum Hamburg West
🇩🇪Hamburg, Germany
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
🇵🇱Krakow, Małopolskie, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
🇵🇱Ruda Slaska, Slaskie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
🇵🇱Lodz, Poland
OMEDICA Medical Center
🇵🇱Poznan, Poland
Poradnia Chorob Metabolicznych
🇵🇱Wierzchosławice, Poland
Praktyka Lekarska
🇵🇱Poznan, Poland
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, Puerto Rico
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
🇦🇷Cordoba, Argentina