A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes; Type 2 Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05362058

I8H-MC-BDCX (Other Identifier)

18262

2021-005891-21 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.

Enrollment: 928 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria

• Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening

• Are 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

• These antihyperglycemic medications are accepted in the study

  • dipeptidyl peptidase-4 (DPP-4) inhibitors
  • sodium-glucose cotransporter 2 (SGLT2) inhibitors
  • biguanides, such as metformin
  • alpha-glucosidase inhibitors
  • glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
  • Sulfonylureas, or
  • Thiazolidinediones.

• Are insulin naïve.

Exceptions:

• short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes

  • Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).

Exclusion criteria

• Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a 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 greater than (>) 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.

• 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.
  • Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
  • Have had significant weight gain or loss within 3 months prior to screening, for example, greater than or equal to (≥) 5%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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928 participants in 2 patient groups

500 U/mL - Insulin Efsitora Alfa

Experimental group

Description:

* Participants received 500 units per milliliter (U/mL) of insulin efsitora alfa administered subcutaneously (SC) once weekly (QW) over a 52-week treatment period, followed by a 5-week safety follow-up period. * Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.

Treatment:

Drug: Insulin Efsitora Alfa

100 U/mL - Insulin Degludec

Active Comparator group

Description:

* Participants received 100 U/mL insulin degludec administered SC once daily (QD) over a 52-week treatment period, followed by a 5-week safety follow-up period. * Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.

Treatment:

Drug: Insulin Degludec