Phase 3 N=692 Randomized Treatment

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

Type 1 Diabetes · Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT05463744 ↗

Enrolled (actual)

692

Serious AEs

10.0%

Results posted

Jun 2025

Primary outcome: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis] — -0.51; -0.56 Percentage of HbA1c

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Insulin Efsitora Alfa (Drug); Insulin Degludec (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis]	-0.51; -0.56	—
SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Superiority Analysis]	-0.51; -0.56	0.432
SECONDARY Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 23 to Week 26	52.54; 52.85	0.751
SECONDARY Nocturnal Hypoglycemia Event Rate	1.99; 1.96	0.900
SECONDARY Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis]	-0.38; -0.40	—
SECONDARY Change From Baseline in Fasting Blood Glucose	-26.67; -25.45; -24.78; -19.93	0.697
SECONDARY Glucose Variability	33.72; 33.69; 33.69; 33.18	0.939
SECONDARY Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 49 to Week 52	50.28; 49.74	0.610
SECONDARY Basal Insulin Dose	199.51; 208.47; 204.37; 211.25	0.155
SECONDARY Bolus Insulin Dose	21.48; 25.25; 22.62; 26.10	<0.001 sig
SECONDARY Total Insulin Dose	343.91; 383.19; 355.66; 391.60	<0.001 sig
SECONDARY Basal Insulin Dose to Total Insulin Dose Ratio	56.4; 53.2; 55.4; 52.6	<0.001 sig
SECONDARY Hypoglycemia Event Rate	14.03; 11.59	0.016 sig
SECONDARY Change From Baseline in Body Weight	1.71; 1.62; 1.96; 1.85	0.702
SECONDARY Percentage of Time in Hypoglycemia Range With Blood Glucose <54 mg/dL (3.0 mmol/L)	0.75; 0.72; 0.74; 0.64	0.681
SECONDARY Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L) From Week 23 to Week 26	44.29; 44.29	0.999
SECONDARY Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L) From Week 49 to Week 52	46.73; 47.56	0.468
SECONDARY Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) at Week 26	14.4; 13.2	0.008 sig
SECONDARY Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) at Week 52	14.4; 12.8	<0.001 sig
SECONDARY Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Acute Form (Physical-Component and Mental-Component) Scores	0.19; -0.24; 0.48; -0.25; 0.58; 0.36	0.270

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05463744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.