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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

Conditions
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Type 1 Diabetes, Diabetes

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


Participation Criteria
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Eligibility Criteria
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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.

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 by subcutaneously (SC) | Drug: Insulin Efsitora Alfa<br>* Administered SC<br>* Other names: LY3209590 and Basal Insulin-FC;|
| Active Comparator: Insulin Degludec<br>Participants will receive insulin degludec SC | Drug: Insulin Degludec<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) |  | Baseline, Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Glucose Range | Time in glucose range between 70 and 180 milligram/deciliter (mg/dL) [3.9 and 10.0 millimole/liter (mmol/L)] inclusive, measured by continued glucose monitoring (CGM) 4 weeks prior to week 26 | Week 22 to Week 26 | 
| Nocturnal Hypoglycemia Event Rate | The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL or severe) measured during treatment phase up to week 52. | Baseline to Week 52 | 
| Change from Baseline in Fasting Glucose | Change from baseline in fasting glucose measured by self-monitoring of blood glucose (SMBG). | Baseline, Week 26 | 
| Glucose Variability | Glucose variability measured by CGM 4 weeks prior to week 26 | Week 22 to Week 26 | 
| Basal Insulin Dose |  | Week 26 | 
| Bolus Insulin Dose |  | Week 26 | 
| Total Insulin Dose |  | Week 26 | 
| Rate of Composite Level 2 and 3 Hypoglycemia Events |  | Baseline to Week 52 | 
| Change from Baseline in Body Weight |  | Baseline, Week 26 | 
| Time in Hypoglycemia Range | Time in hypoglycemia range defined as time in hypoglycemia with glucose <54 mg/dL, measured by CGM 4 weeks prior to week 26. | Week 22 to Week 26 | 
| Time in Hyperglycemia Range | Time in hyperglycemia range defined as glucose >180 mg/dL, measured by CGM 4 weeks prior to week 26. | Week 22 to Week 26 | 
| Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) | DTSQ consists of 8 items and assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia. | Baseline, Week 26 | 
| Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form Domain Scores | SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. | Baseline, Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes (T1D)