A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes; T2D

Treatments: Drug: Insulin Glargine; Drug: Insulin Efsitora Alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT05662332

I8H-MC-BDCW (Other Identifier)

18261

Details and patient eligibility

About

The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.

Enrollment: 795 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of T2D according to the World Health Organization criteria.
• Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.
• Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.
• Are insulin naive

Exceptions:

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

Exclusion criteria

• Have a diagnosis of type 1 diabetes (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 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, ≥5%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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795 participants in 2 patient groups

Insulin Efsitora Alfa

Experimental group

Description:

Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly.

Treatment:

Drug: Insulin Efsitora Alfa

Insulin Glargine

Active Comparator group

Description:

Participants will receive insulin glargine SC once daily.

Treatment:

Drug: Insulin Glargine