> 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-to-b615a998-60f5-4fab-bb54-857439f03fd4 > Record changed: 2026-11-04 # 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 NCT05362058 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) Participants 928 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) Start date 2022-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) Number of sites 113 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Acronym** QWINT-2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Short title** 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](https://clinicaltrials.gov/study/NCT05362058) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Dates **Completion date** 2024-04-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **First posted** 2022-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Registry last updated** 2025-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Primary completion date** 2024-04-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Start date** 2022-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Size and sites **Actual participants** 928 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Participants** 928 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Number of sites** 113 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Identifiers **Registry ID** NCT05362058 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **ClinicalTrials.gov ID** NCT05362058 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Outcomes ### Primary outcomes 1. Change From Baseline in HbA1c at Week 52 \[Noninferiority Analysis\] Timeframe: Baseline, Week 52 \* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. \* Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach. ### Secondary outcomes 1. Change From Baseline in HbA1c at Week 52 in Participants Using GLP-1 Receptor Agonists \[Noninferiority Analysis\] Timeframe: Baseline, Week 52 \* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. \* LS mean was determined using ANCOVA model with Baseline + Country + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach. 2. Change From Baseline in HbA1c at Week 52 in Participants Not Using GLP-1 Receptor Agonists \[Noninferiority Analysis\] Timeframe: Baseline, Week 52 \* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. \* LS mean was determined using ANCOVA model with Baseline + Country + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach. 3. Change From Baseline in HbA1c at Week 52 \[Superiority Analysis\] Timeframe: Baseline, Week 52 \* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. \* LS mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach. 4. 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 Timeframe: Week 48 to Week 52 \* Percentage of time spent within the blood glucose range of 70 to 180 milligrams per deciliter (mg/dL) \\\[3.9 to 10.0 millimoles per liter (mmol/L)\\\], as measured during the continuous glucose monitoring (CGM) session over a 24-hour period, from Week 48 to Week 52\. \* LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed using multiple imputation under the assumption of missing at random, while missing data at Week 48-52 were imputed using a return-to-baseline multiple imputation approach. 5. Change From Baseline in HbA1c at Week 26 \[Superiority Analysis\] Timeframe: Baseline, Week 26 \* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. \* LS mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. 6. 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 Timeframe: Week 22 to Week 26 \* Percentage of time spent within the blood glucose range of 70 to 180 mg/dL (3.9 to 10.0 mmol/L), as measured during the CGM session over a 24-hour period, from Week 22 to Week 26\. \* LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed using multiple imputation under the assumption of missing at random, while missing data at Week 22-26 were imputed using a return-to-baseline multiple imputation approach. 7. Change From Baseline in Fasting Blood Glucose (FBG) Timeframe: Baseline, Week 26, Week 52 Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). 8. Glucose Variability Timeframe: Week 22 to Week 26 and Week 48 to Week 52 \* Glucose variability measured as coefficient of variation (CV) for blood glucose during the CGM session over a 24-hour period, between Week 22 to Week 26 and Week 48 to Week 52 was reported. \* LS mean was determined using Mixed Model Repeated Measures (MMRM) model with Baseline + Country +HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. 9. Basal Insulin Dose Timeframe: Week 26 and Week 52 \* The insulin dose was calculated based on the participant's entry of daily or weekly insulin doses in an electronic diary. The average weekly basal insulin dose at Week 26 and Week 52 was reported. \* LS mean was determined using MMRM model with Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. 10. Hypoglycemia Event Rate Timeframe: Baseline up to Week 52 \* A hypoglycemic event with blood glucose (BG) levels of less than (\\<) 54 mg/dL (3.0 mmol/L) \\\[Level 2\\\] or Severe Hypoglycemia \\\[Level 3\\\] was reported. A severe hypoglycemic event was characterized by altered mental or physical status, requiring the 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 model using Number of episodes = HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. 11. Nocturnal Hypoglycemia Event Rate Timeframe: Baseline up to Week 52 \* The event rate of participant-reported clinically significant nocturnal hypoglycemia (defined as blood glucose level \\<54 mg/dL (3.0 mmol/L) or severe hypoglycemia and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 52\. \* Group mean was reported and determined by Negative binomial model using Number of episodes = HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. 12. Change From Baseline in Body Weight Timeframe: Baseline, Week 26, Week 52 Change from baseline in body weight was reported. LS mean was determined by MMRM model with Baseline + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. 13. Percentage of Time in Hypoglycemia Range With Blood Glucose <70 mg/dL (3.9 mmol/L) Timeframe: Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52 \* Percentage of time spent in the hypoglycemia range with blood glucose \\<70 mg/dL (3.9 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52 was reported. \* LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. 14. Percentage of Time in Hypoglycemia Range With Blood Glucose <54 mg/dL (3.0 mmol/L) Timeframe: Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52 \* Percentage of time spent in the hypoglycemia range with blood glucose \\< 54 mg/dL (3.0 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52, was reported. \* LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. 15. Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L) Timeframe: Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52 \* Percentage of time spent in the hyperglycemia range with blood glucose greater than (\\>) 180 mg/dL (10.0 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52 was reported. \* LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. 16. Change From Baseline in Treatment-Related Impact Measures for Diabetes (TRIM-D) -Total Score at Week 26 and Week 52 Timeframe: Baseline, Week 26, Week 52 \* The TRIM-D is a participant-reported measure designed to assess the impact of diabetes treatment on individuals' functioning and well-being across different diabetes treatments. The questionnaire includes 28 items grouped into 5 sub-domains: treatment burden, daily life, diabetes management, compliance, and psychological health. Each item is assessed on a 5-point scale, with higher scores indicating better health status. All items were summed to obtain a total raw score, which was transformed to a scale of 0 to 100 to obtain a total score. The total score range is 0-100, with a higher total score indicating better overall health and well-being, while a lower total score indicates worse health or well-being. \* LS mean was determined using MMRM model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as variables. 17. 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 Timeframe: Baseline, Week 26, Week 52 The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Each domain is scored individually, and information from these 8 domains is further aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10\. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. 18. 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 Timeframe: Baseline, Week 26, Week 52 The EQ-5D-5L is a multidimensional, health-related, quality-of-life instrument. It includes 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are assessed at 5 levels of response (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The scores in the 5 dimensions were summarized into a health state index score. A single health-state index value was derived, which ranges from less than 0 (health state equivalent to death, negative values are valued as worse than death) to 1 (perfect health). The EQ VAS rates the participants' perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). This score provides a composite picture of the respondent's health status. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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%. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## Sites - Neighborhood Healthcare Institute of HealthEscondido, United States - Valley ResearchFresno, United States - NorCal Medical Research, IncGreenbrae, United States - Catalina Research Institute, LLCMontclair, United States - Southern California Dermatology, Inc.Santa Ana, United States - New West Physicians Clinical ResearchGolden, United States - New England Research Associates, LLCBridgeport, United States - East Coast Institute for Research, LLCJacksonville, United States - East Coast Institute for Research - CantonCanton, United States - Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United States - Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research CooperativeSpringfield, United States - Qualmedica Research, LLCEvansville, United States - Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United States - Qualmedica ResearchBowling Green, United States - MedStar Health Research Institute (MedStar Physician Based Research Network)Hyattsville, United States - Endocrine and Metabolic ConsultantsRockville, United States - SKY Clinical Research Network Group-QuinnRidgeland, United States - Clinvest Research LLCSpringfield, United States - Clarity Clinical ResearchEast Syracuse, United States - Great Lakes Medical Research, LLCWestfield, United States - Monroe Biomedical ResearchMonroe, United States - Lucas Research, IncMorehead City, United States - Intend Research, LLCNorman, United States - Jefferson Clinical Research Institute (JCRI)Philadelphia, United States - Tribe Clinical Research, LLCGreenville, United States And 88 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## References - PubMed 42177728 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42177728/) Related publication - PubMed 41591636 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41591636/) Related publication - PubMed 39254740 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39254740/) Related publication - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/find/completed?trialname=%20I8H-MC-BDCX&externalRequestID=68cbce79-fbf1-46c5-852a-338ca6e2be85) ### Other registry identifiers (2) - 2021-005891-21 - I8H-MC-BDCX Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05362058) ## 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 (2) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) Primary condition - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### 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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