A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

Conditions

• Diabetes
• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Insulin Efsitora Alfa — DRUG
  Administered SC
• Insulin Degludec — DRUG
  Administered SC

Study Details

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.

Key Dates

Start date

Jun 3, 2022

Status verified

May 2025

Primary completion

Apr 10, 2024

Completion

Apr 10, 2024

Study Design

Enrollment

928 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 500 U/mL - Insulin Efsitora Alfa
  * Participants received 500 units per milliliter (U/mL) of insulin efsitora alfa administered subcutaneously (SC) once weekly (QW) over a 52-week treatment period, followed by a 5-week safety follow-up period. * Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.
• Active Comparator: 100 U/mL - Insulin Degludec
  * Participants received 100 U/mL insulin degludec administered SC once daily (QD) over a 52-week treatment period, followed by a 5-week safety follow-up period. * Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.

Primary Outcome Measure

Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] [ Time Frame: Baseline, Week 52 ]

Locations (30)

Related coverage on Hipa.ai

• Insulin Efsitora Alfa Improves Time in Range for Type 2 Diabetes vs. Degludec
  Liraglutide · May 16, 2025 · ClinicalTrials.gov

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