Phase 3
N=986
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05275400 ↗Enrolled (actual)
986
Serious AEs
14.2%
Results posted
Jun 2025
Primary outcome: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority] — -0.81; -0.72 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) [Noninferiority] |
-0.81; -0.72 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority] |
-0.81; -0.72 | 0.088 |
| SECONDARY Nocturnal Hypoglycemia Event Rate |
0.11; 0.10 | 0.897 |
| SECONDARY Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L) |
61.37; 60.95 | 0.722 |
| SECONDARY Change From Baseline in Fasting Glucose |
-30.97; -30.13 | 0.605 |
| SECONDARY Weekly Insulin Dose at Week 26 |
333.20; 363.20 | 0.003 sig |
| SECONDARY Hypoglycemia Event Rate |
0.84; 0.74 | 0.430 |
| SECONDARY Change From Baseline in Body Weight |
2.27; 2.20 | 0.756 |
| SECONDARY Percentage of Time in Hypoglycemia Range |
0.36; 0.22 | 0.021 sig |
| SECONDARY Percentage of Time in Hyperglycemia Range |
37.25; 38.24 | 0.417 |
| SECONDARY Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) |
10.03; 6.88; 10.09; 6.53; 10.33; 6.98 | <0.001 sig |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26 |
14.9; 12.3 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52 |
15.1; 12.3 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78 |
15.4; 11.7 | — |
Summary
The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.
Eligibility Criteria
Inclusion Criteria
- Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
- Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
- Have HbA1c value of 6.5% - 10% inclusive, at screening
- Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
- Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
- once daily U100 or U200 of insulin degludec
- once daily U100 or U300 of insulin glargine
- once or twice daily U100 of insulin detemir, or
- once or twice daily human insulin NPH
- acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
- dipeptidyl peptidase (DPP-4) IV inhibitors
- SGLT2 inhibitors
- metformin
- alphaglucosidase inhibitors or,
- Glucagon-Like Peptide-1 (GLP-1) receptor agonists
- Participants must be willing to stay on stable dose throughout the study
Exclusion Criteria
- Have Type 1 diabetes mellitus
- Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
- Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m²)
- Have active or untreated malignancy
- Are pregnant
- Have a significant weight gain or loss the past 3 months
- Have received anytime in the past 6 months, any of the following insulin therapies:
- prandial insulin
- insulin mixtures
- inhaled insulin
- U-500 insulin, or
- continuous subcutaneous insulin infusion therapy
- Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
- acute myocardial infarctions
- cerebrovascular accident (stroke), or
- coronary bypass surgery
- Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening
Data sourced from ClinicalTrials.gov (NCT05275400). 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.