A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Korábbi kezelés

• Have received anytime in the past 6 months, any of the following insulin therapies:
  • prandial insulin
  • insulin mixtures
  • inhaled insulin
  • U-500 insulin, or
  • continuous subcutaneous insulin infusion therapy
• Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

Más betegség

• Have Type 1 diabetes mellitus
• Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
• Have active or untreated malignancy
• Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
  • acute myocardial infarctions
  • cerebrovascular accident (stroke), or
  • coronary bypass surgery

Laborértékek

• Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)

Egyéb

• Are pregnant
• Have a significant weight gain or loss the past 3 months

• Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
• Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
• Have HbA1c value of 6.5% - 10% inclusive, at screening
• Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
• Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
  • once daily U100 or U200 of insulin degludec
  • once daily U100 or U300 of insulin glargine
  • once or twice daily U100 of insulin detemir, or
  • once or twice daily human insulin NPH
• acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
  • dipeptidyl peptidase (DPP-4) IV inhibitors
  • SGLT2 inhibitors
  • metformin
  • alphaglucosidase inhibitors or,
  • Glucagon-Like Peptide-1 (GLP-1) receptor agonists
  • Participants must be willing to stay on stable dose throughout the study