Trial Outcomes & Findings for A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1) (NCT NCT05662332)
NCT ID: NCT05662332
Last Updated: 2025-08-06
Results Overview
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
795 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2025-08-06
Participant Flow
Participant milestones
| Measure |
Insulin Efsitora Alfa
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Insulin Glargine
Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Overall Study
STARTED
|
397
|
398
|
|
Overall Study
Received at Least One Dose of the Study Drug
|
397
|
398
|
|
Overall Study
COMPLETED
|
362
|
361
|
|
Overall Study
NOT COMPLETED
|
35
|
37
|
Reasons for withdrawal
| Measure |
Insulin Efsitora Alfa
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Insulin Glargine
Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
8
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Protocol Deviation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
14
|
|
Overall Study
Assigned Treatment by Mistake
|
5
|
7
|
|
Overall Study
Non-compliance with study drug
|
4
|
1
|
|
Overall Study
Due to Bariatric surgery
|
1
|
0
|
|
Overall Study
Subject Moving out of State
|
0
|
1
|
|
Overall Study
Subject Missed the Schedule
|
1
|
0
|
|
Overall Study
The Patient Moved to Another City
|
1
|
0
|
Baseline Characteristics
All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline.
Baseline characteristics by cohort
| Measure |
Efsitora
n=397 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=398 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
Total
n=795 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.40 years
STANDARD_DEVIATION 10.02 • n=397 Participants
|
56.20 years
STANDARD_DEVIATION 9.67 • n=398 Participants
|
56.30 years
STANDARD_DEVIATION 9.84 • n=795 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=397 Participants
|
203 Participants
n=398 Participants
|
397 Participants
n=795 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=397 Participants
|
195 Participants
n=398 Participants
|
398 Participants
n=795 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
338 Participants
n=397 Participants
|
336 Participants
n=398 Participants
|
674 Participants
n=795 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=397 Participants
|
61 Participants
n=398 Participants
|
120 Participants
n=795 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=397 Participants
|
1 Participants
n=398 Participants
|
1 Participants
n=795 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
106 Participants
n=397 Participants
|
107 Participants
n=398 Participants
|
213 Participants
n=795 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=397 Participants
|
6 Participants
n=398 Participants
|
9 Participants
n=795 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=397 Participants
|
1 Participants
n=398 Participants
|
2 Participants
n=795 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=397 Participants
|
10 Participants
n=398 Participants
|
23 Participants
n=795 Participants
|
|
Race (NIH/OMB)
White
|
270 Participants
n=397 Participants
|
272 Participants
n=398 Participants
|
542 Participants
n=795 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=397 Participants
|
1 Participants
n=398 Participants
|
4 Participants
n=795 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=397 Participants
|
1 Participants
n=398 Participants
|
2 Participants
n=795 Participants
|
|
Region of Enrollment
Argentina
|
170 participants
n=397 Participants
|
171 participants
n=398 Participants
|
341 participants
n=795 Participants
|
|
Region of Enrollment
Mexico
|
129 participants
n=397 Participants
|
129 participants
n=398 Participants
|
258 participants
n=795 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=397 Participants
|
98 participants
n=398 Participants
|
196 participants
n=795 Participants
|
|
HemoglobinA1c (HbA1c)
|
8.20 Percentage of HbA1c
STANDARD_DEVIATION 0.91 • n=392 Participants • All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline.
|
8.28 Percentage of HbA1c
STANDARD_DEVIATION 1.06 • n=391 Participants • All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline.
|
8.24 Percentage of HbA1c
STANDARD_DEVIATION 0.99 • n=783 Participants • All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline.
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 52, excluding participants discontinuing the study treatment due to inadvertent enrollment. All measurements were included regardless of the use of study treatment or rescue medication.
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.
Outcome measures
| Measure |
Efsitora
n=355 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=360 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis]
|
-1.19 Percentage of HbA1c
Standard Error 0.0546
|
-1.16 Percentage of HbA1c
Standard Error 0.0545
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 52, excluding participants discontinuing the study treatment due to inadvertent enrollment. All measurements were included regardless of the use of study treatment or rescue medication.
HbA1c is the glycated 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 + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.
Outcome measures
| Measure |
Efsitora
n=355 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=360 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Change From Baseline in HbA1c [Superiority]
|
-1.19 Percentage of HbA1c
Standard Error 0.0546
|
-1.16 Percentage of HbA1c
Standard Error 0.0545
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: 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.
Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Efsitora
n=341 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=359 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Change From Baseline in Fasting Glucose
|
-46.76 milligrams per deciliter (mg/dL)
Standard Error 2.0797
|
-50.92 milligrams per deciliter (mg/dL)
Standard Error 2.0595
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
The insulin dose was recorded daily or weekly in an electronic diary. The average weekly basal insulin dose at Week 52 was reported. LS mean was determined using MMRM model with Baseline + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA use at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
Efsitora
n=300 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=336 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Basal Insulin Dose at Week 52
|
289.1 Units per week (U/week)
Standard Error 6.81
|
332.8 Units per week (U/week)
Standard Error 6.68
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: All randomized participants who received at least one dose of the study drug.
Rate of Composite Level 2 and 3 Hypoglycemia Events were reported. Hypoglycemia with glucose \<54 mg/dL (Level 2) or Severe Hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (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 model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Outcome measures
| Measure |
Efsitora
n=397 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=398 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Rate Per Year of Hypoglycemia Events
|
0.50 Events per year
Standard Deviation 0.062
|
0.88 Events per year
Standard Deviation 0.152
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of the study drug.
Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Incidence of Composite Level 2 and 3 Hypoglycemia Events was reported. Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia with glucose \<54 mg/dL (Level 2) or severe hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (Level 3). 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.
Outcome measures
| Measure |
Efsitora
n=397 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=398 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Percentage of Participants With Hypoglycemia Events (Incidence)
|
25.94 percentage of participants
|
29.90 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: All randomized participants who received at least one dose of the study drug.
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 52. 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.
Outcome measures
| Measure |
Efsitora
n=397 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=398 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Rate Per Year of Nocturnal Hypoglycemia Events
|
0.05 Events per year
Standard Error 0.013
|
0.08 Events per year
Standard Error 0.021
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of the study drug.
Incidence of nocturnal hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. 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 52..
Outcome measures
| Measure |
Efsitora
n=397 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=398 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Percentage of Participants With Nocturnal Hypoglycemia Events (Incidence)
|
3.53 percentage of participants
|
5.03 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: 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.
Change from baseline in body weight was reported. LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Efsitora
n=357 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=361 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Change From Baseline in Body Weight
|
3.86 Kilogram (kg)
Standard Error 0.190
|
3.29 Kilogram (kg)
Standard Error 0.189
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: 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.
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. The TRIM-D questionnaire consists of 5 sub-domains. Treatment Burden (6 items) Daily Life (5 items) Diabetes Management (5 items), Compliance (4 items), and Psychological Health (8 items), where each question is scored on a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total scores are later transformed to a 0-100 scale for analysis. LS mean change in scores from baseline to 52 weeks for total score are presented here. LS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA. Use at Randomization + Treatment + Time + Treatment\*Time(Type III sum of squares) as variables.
Outcome measures
| Measure |
Efsitora
n=341 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=342 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Total Score
|
15.4 Score on a scale
Standard Error 0.608
|
13.87 Score on a scale
Standard Error 0.607
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: 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.
The DTSQ-c is a validated, patient-reported questionnaire designed to assess perceived changes in satisfaction with diabetes treatment over time. It is especially useful in clinical trials comparing a new treatment to a previous one. The DTSQ-c includes 8 items, each scored on a 7-point Likert scale ranging from -3 (Much less satisfied) to +3 (Much more satisfied). A score of 0 indicates no change in perception. This outcome reports three domains: (1) Perceived frequency of hypoglycaemia - lower scores reflect fewer perceived episodes; (2) Perceived frequency of hyperglycaemia - lower scores reflect fewer perceived episodes; (3) Treatment satisfaction -Aggregated score from the remaining 6 items assessing satisfaction with treatment, convenience, flexibility, understanding, and willingness to continue. A higher scores indicating greater improvement in satisfaction. Total score range: -18 to +18.
Outcome measures
| Measure |
Efsitora
n=324 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=342 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c)
Perceived frequency of hypoglycemia score
|
-1.2 Score on a scale
Standard Error 1.95
|
-1.3 Score on a scale
Standard Error 1.89
|
|
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c)
Perceived frequency of hyperglycemia score
|
-1.0 Score on a scale
Standard Error 1.84
|
-0.9 Score on a scale
Standard Error 1.80
|
|
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c)
Treatment satisfaction score
|
15.1 Score on a scale
Standard Error 4.57
|
14.5 Score on a scale
Standard Error 4.73
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded.
The SIM-Q is a brief 10-item measure developed to assess the simplicity and complexity of treatment for T2D. This version of the instrument assesses the simplicity and complexity of a single medication. Only the last 2 questions/items of the SIM-Q were completed by the study participants: 1. "How simple or complex is your medication treatment for diabetes?" 2. "Overall, how simple or complex is it to manage your diabetes, including medication, checking your blood glucose levels, diet, and any other aspects of diabetes treatment?" Participants were asked to provide responses to the study intervention at Week 52. Each item is scored on a 5-point scale ranging from "Very complex" to "Very simple." Higher scores indicate a more favorable (simpler) treatment experience.
Outcome measures
| Measure |
Efsitora
n=317 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=335 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - How Simple or Complex Medication: Very Complex
|
2.5 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - How Simple or Complex Medication: Complex
|
0.3 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - How Simple or Complex Medication: A Little Complex
|
6.0 Percentage of participants
|
6.6 Percentage of participants
|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - How Simple or Complex Medication: Simple
|
37.2 Percentage of participants
|
41.2 Percentage of participants
|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - How Simple or Complex Medication: Very Simple
|
53.9 Percentage of participants
|
48.7 Percentage of participants
|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - Overall How to Manage Diabetes: Very Complex
|
1.6 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - Overall How to Manage Diabetes: Complex
|
4.7 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - Overall How to Manage Diabetes : A Little Complex
|
16.4 Percentage of participants
|
15.5 Percentage of participants
|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - Overall How to Manage Diabetes: Simple
|
41.0 Percentage of participants
|
40.3 Percentage of participants
|
|
Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version
SIMQF - Overall How to Manage Diabetes: Very Simple
|
36.3 Percentage of participants
|
36.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: 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.
DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems.This outcome measure reports only the Device Characteristics Subscale, which includes Items 1 through 7. These items evaluate specific features of injection devices such as: * Ease of preparation * Comfort during injection * Portability * Discreetness * Confidence in dose delivery * Ease of learning to use * Satisfaction with device features Each item is rated on a 4-point Likert scale: Strongly Disagree, Disagree, Agree, Strongly Agree. Responses are transformed to a 0-100 scale, where 0 represents most negative perception and 100 represents the most positive perception.Higher scores indicate more favorable perceptions of the injection device. LS Mean determined using ANCOVA model with Country + GLP-1 RA Use at Randomization + HbA1c Stratum at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
Efsitora
n=344 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=345 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Change From Baseline in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics
|
91.4 score on a scale
Standard Error 0.71
|
89.6 score on a scale
Standard Error 0.71
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded.
The DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems. This outcome measure specifically reports the summary of DID-EQ scores for the 3 global items: * Item 8: Overall satisfaction with the injection device * Item 9: Ease of use of the injection device * Item 10: Convenience of the injection device Each item is rated on a 4-point Likert scale: * Strongly Disagree * Disagree * Agree * Strongly Agree Responses are transformed to a 0-100 scale, where: * 0 = Most negative perception * 100 = Most positive perception Higher scores indicate more favorable perceptions of the injection device's global characteristics.
Outcome measures
| Measure |
Efsitora
n=344 Participants
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=345 Participants
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Satisfied with the Injection Device (Strongly disagree)
|
0.3 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Satisfied with the Injection Device (Disagree)
|
0 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Satisfied with the Injection Device (Agree)
|
15.4 percentage of participants
|
19.1 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Satisfied with the Injection Device (Strongly Agree)
|
84.3 percentage of participants
|
79.4 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Easy to Use the Injection Device (Strongly disagree)
|
0.3 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Easy to Use the Injection Device (Disagree)
|
0 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Easy to Use the Injection Device (Agree)
|
14.0 percentage of participants
|
17.1 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Easy to Use the Injection Device (Strongly Agree)
|
85.8 percentage of participants
|
81.7 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Convenient to Use the Injection Device (Strongly disagree)
|
0.3 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Convenient to Use the Injection Device (Disagree)
|
0 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Convenient to Use the Injection Device (Agree)
|
17.4 percentage of participants
|
20.3 percentage of participants
|
|
Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)
Convenient to Use the Injection Device (Strongly agree)
|
82.3 percentage of participants
|
78.3 percentage of participants
|
Adverse Events
Efsitora
Serious events: 26 serious events
Other events: 104 other events
Deaths: 3 deaths
Glargine
Serious events: 21 serious events
Other events: 121 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Efsitora
n=397 participants at risk
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=398 participants at risk
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
2/397 • Number of events 2 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/398 • Number of events 2 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.50%
2/397 • Number of events 2 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.50%
2/397 • Number of events 2 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/398 • Number of events 2 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacteraemia
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 2 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.50%
2/397 • Number of events 2 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 2 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dermatofibrosarcoma protuberans
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.50%
2/397 • Number of events 2 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.52%
1/194 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/203 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.52%
1/194 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/203 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.25%
1/397 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/398 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/203 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
1/195 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/397 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/398 • Number of events 1 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Efsitora
n=397 participants at risk
Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.
|
Glargine
n=398 participants at risk
Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.
|
|---|---|---|
|
Infections and infestations
Covid-19
|
5.3%
21/397 • Number of events 21 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
9/398 • Number of events 9 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
7.3%
29/397 • Number of events 30 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.8%
23/398 • Number of events 26 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
18/397 • Number of events 20 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.3%
25/398 • Number of events 27 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Drug titration error
|
3.3%
13/397 • Number of events 14 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.8%
39/398 • Number of events 53 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
5.0%
20/397 • Number of events 24 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
20/398 • Number of events 24 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
5.3%
21/397 • Number of events 24 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
16/398 • Number of events 19 • Baseline up to Week 57
All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60