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

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Insulin Efsitora Alfa; Drug: Insulin Degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT05275400

2021-002569-16 (EudraCT Number)

18237

I8H-MC-BDCU (Other Identifier)

Details and patient eligibility

About

The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Enrollment: 986 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

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

• Have active or untreated malignancy

• Are pregnant

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

• 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

• 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

• Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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986 participants in 2 patient groups

Insulin Efsitora Alfa

Experimental group

Description:

Participants will be given insulin efsitora alfa subcutaneously (SC).

Treatment:

Drug: Insulin Efsitora Alfa

Insulin Degludec

Active Comparator group

Description:

Participants with be given insulin degludec SC.

Treatment:

Drug: Insulin Degludec