Phase 3
N=928
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
Diabetes · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05362058 ↗Enrolled (actual)
928
Serious AEs
8.5%
Results posted
May 2025
Primary outcome: Primary: Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] — -1.26; -1.17 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
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] |
-1.26; -1.17 | — |
| SECONDARY Change From Baseline in HbA1c at Week 52 in Participants Using GLP-1 Receptor Agonists [Noninferiority Analysis] |
-1.26; -1.19 | — |
| SECONDARY Change From Baseline in HbA1c at Week 52 in Participants Not Using GLP-1 Receptor Agonists [Noninferiority Analysis] |
-1.26; -1.15 | — |
| SECONDARY Change From Baseline in HbA1c at Week 52 [Superiority Analysis] |
-1.26; -1.17 | 0.188 |
| SECONDARY Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 48 to Week 52 |
64.27; 61.18 | 0.043 sig |
| SECONDARY Change From Baseline in HbA1c at Week 26 [Superiority Analysis] |
-1.37; -1.30 | 0.260 |
| SECONDARY Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 22 to Week 26 |
66.12; 65.85 | 0.848 |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) |
-57.86; -63.04; -59.77; -59.97 | 0.014 sig |
| SECONDARY Glucose Variability |
26.31; 26.67; 26.29; 26.81 | 0.310 |
| SECONDARY Basal Insulin Dose |
292.8; 305.9; 314.7; 334.4 | 0.136 |
| SECONDARY Hypoglycemia Event Rate |
0.58; 0.45 | 0.111 |
| SECONDARY Nocturnal Hypoglycemia Event Rate |
0.08; 0.08 | 0.983 |
| SECONDARY Change From Baseline in Body Weight |
3.16; 2.66; 3.60; 3.54 | 0.025 sig |
| SECONDARY Percentage of Time in Hypoglycemia Range With Blood Glucose <70 mg/dL (3.9 mmol/L) |
1.06; 0.93; 1.55; 1.25; 1.49; 1.19 | 0.374 |
| SECONDARY Percentage of Time in Hypoglycemia Range With Blood Glucose <54 mg/dL (3.0 mmol/L) |
0.24; 0.27; 0.33; 0.28; 0.32; 0.30 | 0.594 |
| SECONDARY Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L) |
31.99; 32.40; 28.93; 29.87; 29.66; 33.05 | 0.757 |
| SECONDARY Change From Baseline in Treatment-Related Impact Measures for Diabetes (TRIM-D) -Total Score at Week 26 and Week 52 |
8.84; 7.18; 8.82; 6.81 | 0.021 sig |
| SECONDARY Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores at Week 26 and Week 52 |
0.29; 0.49; 0.018; 0.34; 0.027; -0.14 | 0.638 |
| SECONDARY Change From Baseline in EuroQuality of Life (EuroQol) - 5 Dimensions-5 Levels (EQ-5D-5L) Health State Index and EQ Visual Analog Scale (VAS) Scores at Week 26 and Week 52 |
-0.018; -0.004; 1.07; 2.18; -0.018; -0.008 | 0.128 |
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.
Eligibility Criteria
Inclusion Criteria
- Have diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria
- Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
- Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study
- These antihyperglycemic medications are accepted in the study
- dipeptidyl peptidase-4 (DPP-4) inhibitors
- sodium-glucose cotransporter 2 (SGLT2) inhibitors
- biguanides, such as metformin
- alpha-glucosidase inhibitors
- glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
- Sulfonylureas, or
- Thiazolidinediones.
- Are insulin naïve.
Exceptions:
- short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes
- Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).
Exclusion Criteria
- Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes.
- Have a history of greater than (>) 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. Have had severe hypoglycemia episodes within 6 months prior to screening. Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
- Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
- Acute myocardial infarction
- Cerebrovascular accident (stroke), or
- Coronary bypass surgery.
- Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
- Have had significant weight gain or loss within 3 months prior to screening, for example, greater than or equal to (≥) 5%.
Data sourced from ClinicalTrials.gov (NCT05362058). 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.