Efficacy and Safety of LY3209590 Compared to Degludec in Adults with Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

Phase 1

Conditions: MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2021-005891-21-GR

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 888

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

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