Trial · NCT05463744
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
NCT05463744, Phase 3, Completed, Eli Lilly and Company; results first posted 2025-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy. Trials, record NCT05463744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05463744
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
- NCT number
- NCT05463744
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 692 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Type 1 Diabetes, Diabetes
- Interventions
- Insulin Efsitora Alfa, Insulin Degludec
- First posted
- 2022-07-19
- Last updated
- 2025-06-24
- Other registries' IDs
- eudract:2021-005892-38
- Results first posted
- 2025-06-24
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis] | Baseline, Week 26 | HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with treatment + country + CGM use prior to study entry \[yes/no\]+ carbohydrate counting for prandial insulin\[yes/no\] + baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. |
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Superiority Analysis] | Baseline, Week 26 | HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was determined using ANCOVA model with treatment + country + CGM use prior to study entry \[yes/no\] + carbohydrate counting for prandial insulin\[yes/no\] + baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. |
| Secondary | Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 23 to Week 26 | Week 23 to Week 26 | Percentage of time in glucose range between 70 and 180 milligram per deciliter (mg/dL) \[3.9 and 10.0 millimole per liter (mmol/L)\], measured by continued glucose monitoring (CGM) from week 23 to week 26 inclusive over a 24-Hour Period. The time component of the time-in-range statistic was calculated using the display time recorded by the CGM device. LS mean was determined using ANCOVA model with treatment + country + CGM use prior to study entry \[yes/no\] + carbohydrate counting for prandial insulin dosing \[yes/no\] + Hemoglobin A1c Stratum at Baseline and baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 23-26 were imputed by return-to-baseline multiple imputations approach |
| Secondary | Nocturnal Hypoglycemia Event Rate | 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 = Baseline hypoglycemia rate + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. |
| Secondary | Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] | Baseline, Week 52 | HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was determined using ANCOVA model with treatment + country + CGM use prior to study entry \[yes/no\]+ carbohydrate counting for prandial insulin\[yes/no\] + baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach |
| Secondary | Change From Baseline in Fasting Blood Glucose | Baseline, Week 26, and Week 52 | Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). LS mean was determined using ANCOVA model with treatment, country, CGM use prior to study entry \[yes/no\], carbohydrate counting for prandial insulin dosing \[yes/no\]) and baseline value of the dependent variable as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data were imputed by return-to-baseline multiple imputations approach. |
| Secondary | Glucose Variability | Week 23 to Week 26 and Week 49 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 23 to Week 26 and Week 49 to Week 52 was reported. LS mean was determined using mixed model repeated measures (MMRM) model with BASELINE + Country + Prior CGM use + Carbohydrate counting for Prandial Dose + Hemoglobin A1c Stratum at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Unstructured variance-covariance structure was used. |
| Secondary | Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 49 to Week 52 | Week 49 to Week 52 | 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 49 to Week 52. LS mean was determined using ANCOVA model with treatment, country, CGM use prior to study entry \[yes/no\], carbohydrate counting for prandial insulin dosing \[yes/no\]) and Hemoglobin A1c Stratum at baseline and baseline value of the dependent variable as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data were imputed by return-to-baseline multiple imputations approach. |
| Secondary | Basal Insulin Dose | Week 26 and Week 52 | The insulin dose was recorded daily or weekly 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 BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Prior CGM use + Carbohydrate counting for Prandial Dose + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry. |
| Secondary | Bolus Insulin Dose | Week 26 and Week 52 | The insulin dose was recorded daily or weekly in an electronic diary. The average daily bolus insulin dose at Week 26 and Week 52 was reported. LS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Prior CGM use + Carbohydrate counting for Prandial Dose + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis] | Baseline, Week 26 | All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 26. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Superiority Analysis] | Baseline, Week 26 | All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 26. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 23 to Week 26 | Week 23 to Week 26 | All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 23-26 were included. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Percentage of time | LEAST_SQUARES_MEAN |
| SECONDARY | Nocturnal Hypoglycemia Event Rate | Baseline up to Week 52 | All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome. | events per year | MEAN |
| SECONDARY | Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] | Baseline, Week 52 | All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 52. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Blood Glucose | Baseline, Week 26, and Week 52 | All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome at Baseline, Week 26, or Week 52 were included in the analysis. For the Week 26 analysis, data from Baseline or Week 26 were considered, while for the Week 52 analysis, data from Baseline or Week 52 were included. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | milligram per deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Glucose Variability | Week 23 to Week 26 and Week 49 to Week 52 | All randomized participants who took at least one dose of the study drug and had a baseline and at least one post- baseline value for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded | percentage of CV | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 49 to Week 52 | Week 49 to Week 52 | All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 49-52 were included in the analysis. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | percentage of time | LEAST_SQUARES_MEAN |
| SECONDARY | Basal Insulin Dose | Week 26 and Week 52 | All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline value for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Units per week (U/week) | LEAST_SQUARES_MEAN |
| SECONDARY | Bolus Insulin Dose | Week 26 and Week 52 | All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline value for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded. | Units per day (U/day) | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis] | 500 U/mL Insulin Efsitora Alfa | -0.51 | Standard Error 0.0469 | Percentage of HbA1c | |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Noninferiority Analysis] | 100 U/mL Insulin Degludec | -0.56 | Standard Error 0.0463 | Percentage of HbA1c | |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Superiority Analysis] | 500 U/mL Insulin Efsitora Alfa | -0.51 | Standard Error 0.0469 | Percentage of HbA1c | |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [Superiority Analysis] | 100 U/mL Insulin Degludec | -0.56 | Standard Error 0.0463 | Percentage of HbA1c | |
| Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 23 to Week 26 | 500 U/mL Insulin Efsitora Alfa | 52.54 | Standard Error 0.691 | Percentage of time | |
| Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] From Week 23 to Week 26 | 100 U/mL Insulin Degludec | 52.85 | Standard Error 0.684 | Percentage of time | |
| Nocturnal Hypoglycemia Event Rate | 500 U/mL Insulin Efsitora Alfa | 1.99 | Standard Error 0.180 | events per year | |
| Nocturnal Hypoglycemia Event Rate | 100 U/mL Insulin Degludec | 1.96 | Standard Error 0.177 | events per year | |
| Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] | 500 U/mL Insulin Efsitora Alfa | -0.38 | Standard Error 0.0484 | percentage of HbA1c | |
| Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis] | 100 U/mL Insulin Degludec | -0.40 | Standard Error 0.0479 | percentage of HbA1c |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | 500 U/mL Insulin Efsitora Alfa | 343 | |
| Treatment Period | STARTED | 100 U/mL Insulin Degludec | 349 | |
| Treatment Period | Received at Least One Dose of Study Drug | 500 U/mL Insulin Efsitora Alfa | 343 | |
| Treatment Period | Received at Least One Dose of Study Drug | 100 U/mL Insulin Degludec | 349 | |
| Treatment Period | COMPLETED | 500 U/mL Insulin Efsitora Alfa | 316 | |
| Treatment Period | COMPLETED | 100 U/mL Insulin Degludec | 319 | |
| Treatment Period | NOT COMPLETED | 500 U/mL Insulin Efsitora Alfa | 27 | |
| Treatment Period | NOT COMPLETED | 100 U/mL Insulin Degludec | 30 | |
| Follow-Up Period | STARTED | 500 U/mL Insulin Efsitora Alfa | 332 | |
| Follow-Up Period | STARTED | 100 U/mL Insulin Degludec | 326 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Covid-19 | Infections and infestations | 500 U/mL Insulin Efsitora Alfa | 16 | 343 | 16 |
| other | Covid-19 | Infections and infestations | 100 U/mL Insulin Degludec | 23 | 349 | 24 |
| other | Influenza | Infections and infestations | 500 U/mL Insulin Efsitora Alfa | 27 | 343 | 30 |
| other | Influenza | Infections and infestations | 100 U/mL Insulin Degludec | 18 | 349 | 22 |
| other | Nasopharyngitis | Infections and infestations | 500 U/mL Insulin Efsitora Alfa | 40 | 343 | 45 |
| other | Nasopharyngitis | Infections and infestations | 100 U/mL Insulin Degludec | 42 | 349 | 54 |
| other | Upper respiratory tract infection | Infections and infestations | 500 U/mL Insulin Efsitora Alfa | 24 | 343 | 29 |
| other | Upper respiratory tract infection | Infections and infestations | 100 U/mL Insulin Degludec | 30 | 349 | 35 |
| other | Urinary tract infection | Infections and infestations | 500 U/mL Insulin Efsitora Alfa | 21 | 343 | 24 |
| other | Urinary tract infection | Infections and infestations | 100 U/mL Insulin Degludec | 11 | 349 | 16 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 500 U/mL Insulin Efsitora Alfa | 0 | 343 |
| Total, all-cause mortality | 100 U/mL Insulin Degludec | 1 | 349 |
| Total, other adverse events | 500 U/mL Insulin Efsitora Alfa | 117 | 343 |
| Total, other adverse events | 100 U/mL Insulin Degludec | 119 | 349 |
| Total, serious adverse events | 500 U/mL Insulin Efsitora Alfa | 45 | 343 |
| Total, serious adverse events | 100 U/mL Insulin Degludec | 24 | 349 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39270686 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 500 U/mL Insulin Efsitora Alfa vs 100 U/mL Insulin Degludec: deaths from any cause | Trial comparisons |
| 500 U/mL Insulin Efsitora Alfa vs 100 U/mL Insulin Degludec: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT05463744/results?page=2