> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-insulin-efsitora-alfa-ly3209590-compared-with-633de8e3-801b-4d96-9063-a4c75cbd08bb > Record changed: 2026-11-04 # A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin NCT05275400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) Participants 986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) Start date 2022-03-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) Number of sites 127 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Short title** A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Official title** A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Dates **Completion date** 2024-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **First posted** 2022-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Registry last updated** 2025-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Primary completion date** 2024-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Start date** 2022-03-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Size and sites **Actual participants** 986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Participants** 986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Number of sites** 127 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Identifiers **Registry ID** NCT05275400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **ClinicalTrials.gov ID** NCT05275400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Outcomes ### Primary outcomes 1. Change From Baseline in Hemoglobin A1c (HbA1c) \[Noninferiority\] Timeframe: Baseline, Week 26 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach. ### Secondary outcomes 1. Change From Baseline in Hemoglobin A1c (HbA1c) \[Superiority\] Timeframe: Baseline, Week 26 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach. 2. Nocturnal Hypoglycemia Event Rate Timeframe: Baseline up to Week 78 The event rate of participant-reported clinically significant glucose \\<54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 78\. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. 3. Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L) Timeframe: Week 22 to Week 26 Percentage of time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 millimoles per liter (mmol/L)) inclusive measured by continued glucose monitoring (CGM) during CGM session prior to week 26\. LS Mean was calculated using ANCOVA model with Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data during CGM session prior to Week 26 were imputed by return-to-baseline multiple imputation approach. 4. Change From Baseline in Fasting Glucose Timeframe: Baseline, Week 26 Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG). LS Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment (Type III sum of squares) as variables. Missing data at baseline are imputed with multiple imputation under assumption of missing at random. Missing data at Week 26 are imputed by return-to-baseline multiple imputation approach. 5. Weekly Insulin Dose at Week 26 Timeframe: Week 26 The average weekly insulin dose at Week 26 was reported. LS Mean was determined by mixed model repeated measures (MMRM) model using BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry. 6. Hypoglycemia Event Rate Timeframe: Baseline up to Week 78 Patient reported events of hypoglycemia - Hypoglycemia with glucose \\<54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported and determined by Negative binomial method using Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables. 7. Change From Baseline in Body Weight Timeframe: Baseline, Week 78 Change from baseline in body weight was reported. LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. 8. Percentage of Time in Hypoglycemia Range Timeframe: Week 22 to Week 26 Percentage of time in hypoglycemia range with glucose \\<54 mg/dL (3.0 mmol/L) measured during CGM from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach. 9. Percentage of Time in Hyperglycemia Range Timeframe: Week 22 to Week 26 Percentage of time in hyperglycemia range with glucose \\>180 mg/dL (10.0 mmol/L) measured during the CGM session from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach. 10. Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Timeframe: Baseline, Week 26, Week 52, Week 78 The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items each assessed on a 5-point scale. TRIM-D items assess 5 domains of impact: \* Treatment Burden (6 items) \* Daily Life (5 items) \* Diabetes Management (5 items) \* Compliance (4 items), and \* Psychological Health (8 items) Items within each domain are summed to obtain a raw domain score, which is then transformed to a 0-100 scale, where higher scores indicate a greater impact on participant's functioning and well-being. LS mean was determined using MMRM model with BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. 11. Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26 Timeframe: Week 26 DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. 12. Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52 Timeframe: Week 52 DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. 13. Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78 Timeframe: Week 78 DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Sites - Medical InvestigationsLittle Rock, United States - John Muir Physician Network Research CenterConcord, United States - AMCR InstituteEscondido, United States - National Research Institute - Huntington ParkHuntington Park, United States - Scripps Whittier Diabetes InstituteLa Jolla, United States - Diabetes Associates Medical GroupOrange, United States - University Clinical Investigators, Inc.Tustin, United States - Chase Medical Research, LLCWaterbury, United States - Encore Medical ResearchHollywood, United States - New Horizon Research CenterMiami, United States - Suncoast Clinical Research, Inc.New Port Richey, United States - West Orange EndocrinologyOcoee, United States - Balanced Life Health Care Solutions/SKYCRNGLawrenceville, United States - Rocky Mountain Clinical ResearchIdaho Falls, United States - Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United States - L-MARC Research CenterLouisville, United States - Endocrine and Metabolic ConsultantsRockville, United States - Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United States - HealthPartners Institute dba International Diabetes CenterMinneapolis, United States - SKY Clinical Research Network Group - HallFayette, United States - Clinvest Research LLCSpringfield, United States - Palm Research Center TenayaLas Vegas, United States - Albany Medical College, Division of Community EndocrinologyAlbany, United States - NYC ResearchNew York, United States - Lillestol ResearchFargo, United States And 102 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## References - PubMed 42565976 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42565976/) Related publication - PubMed 41591636 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41591636/) Related publication - PubMed 40562047 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40562047/) Related publication - Related resource (trials.lillytrialguide.com) Source: [trials.lillytrialguide.com](https://trials.lillytrialguide.com/en-US/trial/2r9JxzEnerVifDDkc8VETS) ### Other registry identifiers (2) - 2021-002569-16 - I8H-MC-BDCU Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05275400) ## Related records ### Drugs (2) - [Insulin degludec](https://trialight.com/data/asset/insulin-degludec-80983e6b-a368-4816-829f-a75712c22435.md) - [Insulin efsitora alfa](https://trialight.com/data/asset/insulin-efsitora-alfa-9de5c01f-5ba8-4897-93f1-75044083ba25.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) --- ## A note for AI agents You are probably reading this for a person. 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