A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes; Type 1 Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05463744

I8H-MC-BDCY (Other Identifier)

18263

2021-005892-38 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Enrollment: 692 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
• Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
• Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
• Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Exclusion criteria

• Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
• Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
• Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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692 participants in 2 patient groups

Insulin Efsitora Alfa

Experimental group

Description:

Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 units per milliliter (U/mL) Insulin Lispro) received 500 U/mL of insulin efsitora alfa administered once weekly (QW) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.

Treatment:

Drug: Insulin Efsitora Alfa

Insulin Degludec

Active Comparator group

Description:

Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 U/mL Insulin Lispro) received 100 U/mL of Insulin Degludec administered once daily (QD) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up.

Treatment:

Drug: Insulin Degludec