MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: LY3209590
Product Code: LY3209590
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LY3209590
Other descriptive name: LY3209590
Concentration unit: U/ml
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Must be at least 18 years of age at screening (or older per local regulations) Have a diagnosis of T2D according to the World Health Organization criteria Have an HbA1c of 7.0%-10.5%, inclusive, as determined by central laboratory at screening. To be on a stable treatment with 1 to 3 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study. Therapies must be used in accordance with the corresponding local product label. These antihyperglycemic medications are accepted in the study - DPP-4 inhibitors - SGLT2 inhibitors - biguanides, such as metformin - alpha-glucosidase inhibitors - GLP-1 receptor agonists, oral or injectable - sulfonylureas, or - thiazolidinediones To be insulin naïve Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 799 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 89
Exclusion criteria
Exclusion criteria: Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening Have had severe hypoglycemia episodes within 6 months prior to screening Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate <20 mL/min/1.73 m2 as calculated by the Chronic Kidney Disease-Epidemiology equation, determined by central laboratory at screening Have had a blood transfusion or severe blood loss within 90 days prior to screening. Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c. Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening - acute myocardial infarction - cerebrovascular accident (stroke), or - coronary bypass surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate noninferiority of LY3209590 compared to insulin degludec for the treatment of T2D in adults;Secondary Objective: Demonstrate noninferiority of LY3209590 compared to insulin degludec for participants using, or not using GLP-1 receptor agonists, and demonstrate superiority of LY3209590 compared to insulin degludec in selected parameters of glycemic control;Primary end point(s): Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in HbA1c from baseline to Week 52 - Time in glucose range between 70 and 180 mg/dL, (3.9 and 10.0 mmol/L), inclusive, collected during the CGM session prior to Week 52;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
Brazil, Canada, China, Greece, Japan, Korea, Republic of, Mexico, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed