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)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes

Conditions
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Type 2 Diabetes, T2D

Intervention / Treatment
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* Drug: Insulin Efsitora Alfa
* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Efsitora Alfa<br>Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly. | Drug: Insulin Efsitora Alfa<br>* Administered SC<br>* Other names: LY3209590 and Basal Insulin-FC;|
| Active Comparator: Insulin Glargine<br>Participants will receive insulin glargine SC once daily. | Drug: Insulin Glargine<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Demonstrate noninferiority of insulin efsitora alfa compared to insulin glargine | Baseline, Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in HbA1c | Demonstrate superiority of insulin efsitora alfa compared to insulin glargine | Baseline, Week 52 | 
| Change from Baseline in Fasting Glucose | Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG) | Baseline, Week 52 | 
| Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence | Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period. | Week 52 | 
| Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence | Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period. | Week 52 | 
| Change from Baseline in Body Weight |  | Baseline, Week 52 | 
| Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction | DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia. | Baseline, Week 52 | 
| Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) | TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. | Baseline, Week 52 | 
| Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity | SIM-Q assess the simplicity and complexity of treatment for type 2 diabetes (single medication). | Baseline, Week 52 | 
| Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics | DID-EQ assesses participants' perceptions of non-insulin diabetes injection delivery systems for type 2 diabetes. | Baseline, Week 52 |