CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 928 enrolled
Drug / intervention
Insulin Efsitora Alfa +1 moredrug
Likely dose
Insulin Efsitora Alfa administered subcutaneously weekly; Insulin Degludec administered subcutaneously (frequency not specified in criteria)AI-extracted
Key inclusion· 5
  • ✓Diagnosis of Type 2 diabetes per WHO criteria
  • ✓HbA1c 7.0–10.5% at screening
  • ✓On stable treatment with 1 to 3 oral antihyperglycemic medications for ≥3 months prior to screening
  • ✓Insulin naïve (short-term insulin ≤14 days or prior gestational diabetes treatment allowed)
Key exclusion· 8
  • ✕Type 1 diabetes or other specific diabetes types (latent autoimmune, monogenic, exocrine pancreas disease, drug/chemical-induced)
  • ✕>1 episode of ketoacidosis, hyperosmolar state, or coma requiring hospitalization within 6 months prior to screening
  • ✕Severe hypoglycemia episodes within 6 months prior to screening
  • ✕History of renal transplantation, currently receiving renal dialysis, or eGFR below threshold (specific value not stated)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05362058
NCT05362058Phase 3Completed
CompareCT.gov

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes

Eli Lilly and Company·interventional·Posted May 5, 2022·Updated May 16, 2025

In Brief

A Phase 3 clinical trial evaluating Insulin Efsitora Alfa and Insulin Degludec for Diabetes and Type 2 Diabetes. Completed, enrolled 928 participants across 113 sites in 11 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Type 2 Diabetes
CountriesBrazil, Canada, China, Czechia, Germany, Greece, Japan, Mexico, Puerto Rico, South Korea, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 5, 2022
Enrollment StartJun 3, 2022
Primary CompletionApr 10, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.2 years ago

Interventions

Insulin Efsitora Alfadrug

Administered SC

Insulin Degludecdrug

Administered SC