Phase 3
Completed 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
Source: ClinicalTrials.gov NCT05362058 ↗Enrolled (actual)
928
Serious AEs
8.5%
Results posted
May 2025
Primary outcomePrimary: Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] — -1.26; -1.17 Percentage of HbA1c
◆ Published Evidence
Established
51citations · ~26 / year
Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment.
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.
Linked Publications (3)
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Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment.
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Evaluation of Overall Health State, Treatment Burden, and Satisfaction with Insulin Efsitora Alfa (Efsitora) vs. Daily Comparator in Adults with Type 2 Diabetes in the QWINT Clinical Trial Program.
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Efficacy and Safety of Insulin Efsitora Versus Degludec in Adults with Type 2 Diabetes Who Are Insulin-Naïve: Japan Subgroup Analysis of QWINT-2.
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 |
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) and the linked publication. 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. Informational only — not medical advice.