Trial Outcomes & Findings for A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (NCT NCT05462756)
NCT ID: NCT05462756
Last Updated: 2025-04-27
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
730 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2025-04-27
Participant Flow
Participants underwent a 26-week treatment period, followed by a 5-week safety follow-up period.
Participant milestones
| Measure |
500 U/mL - Insulin Efsitora
Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
Participants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Treatment Period
STARTED
|
365
|
365
|
|
Treatment Period
Received At Least 1 Dose of Study Drug
|
365
|
365
|
|
Treatment Period
COMPLETED
|
348
|
344
|
|
Treatment Period
NOT COMPLETED
|
17
|
21
|
|
Follow-Up Period
STARTED
|
357
|
354
|
|
Follow-Up Period
COMPLETED
|
352
|
349
|
|
Follow-Up Period
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
500 U/mL - Insulin Efsitora
Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
Participants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Treatment Period
Adverse Event
|
3
|
0
|
|
Treatment Period
Assigned Treatment by Mistake
|
4
|
3
|
|
Treatment Period
Death
|
0
|
1
|
|
Treatment Period
Lost to Follow-up
|
2
|
1
|
|
Treatment Period
Non-Compliance with Study Drug
|
1
|
3
|
|
Treatment Period
Physician Decision
|
2
|
0
|
|
Treatment Period
Protocol Violation
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
5
|
12
|
|
Follow-Up Period
Adverse Event
|
1
|
0
|
|
Follow-Up Period
Death
|
1
|
0
|
|
Follow-Up Period
Lost to Follow-up
|
3
|
1
|
|
Follow-Up Period
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
All participants who received at least one dose of study drug and had baseline HbA1c value.
Baseline characteristics by cohort
| Measure |
500 U/mL - Insulin Efsitora
n=365 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=365 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
Total
n=730 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 10.5 • n=365 Participants
|
59.4 years
STANDARD_DEVIATION 10.5 • n=365 Participants
|
58.9 years
STANDARD_DEVIATION 10.5 • n=730 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=365 Participants
|
176 Participants
n=365 Participants
|
369 Participants
n=730 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=365 Participants
|
189 Participants
n=365 Participants
|
361 Participants
n=730 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
201 Participants
n=365 Participants
|
203 Participants
n=365 Participants
|
404 Participants
n=730 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
163 Participants
n=365 Participants
|
161 Participants
n=365 Participants
|
324 Participants
n=730 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=365 Participants
|
1 Participants
n=365 Participants
|
2 Participants
n=730 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
46 Participants
n=365 Participants
|
45 Participants
n=365 Participants
|
91 Participants
n=730 Participants
|
|
Race (NIH/OMB)
Asian
|
54 Participants
n=365 Participants
|
51 Participants
n=365 Participants
|
105 Participants
n=730 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=365 Participants
|
0 Participants
n=365 Participants
|
0 Participants
n=730 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=365 Participants
|
11 Participants
n=365 Participants
|
31 Participants
n=730 Participants
|
|
Race (NIH/OMB)
White
|
245 Participants
n=365 Participants
|
258 Participants
n=365 Participants
|
503 Participants
n=730 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=365 Participants
|
0 Participants
n=365 Participants
|
0 Participants
n=730 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=365 Participants
|
0 Participants
n=365 Participants
|
0 Participants
n=730 Participants
|
|
Region of Enrollment
Argentina
|
83 Participants
n=365 Participants
|
83 Participants
n=365 Participants
|
166 Participants
n=730 Participants
|
|
Region of Enrollment
Germany
|
27 Participants
n=365 Participants
|
24 Participants
n=365 Participants
|
51 Participants
n=730 Participants
|
|
Region of Enrollment
India
|
50 Participants
n=365 Participants
|
50 Participants
n=365 Participants
|
100 Participants
n=730 Participants
|
|
Region of Enrollment
Italy
|
11 Participants
n=365 Participants
|
15 Participants
n=365 Participants
|
26 Participants
n=730 Participants
|
|
Region of Enrollment
Mexico
|
85 Participants
n=365 Participants
|
84 Participants
n=365 Participants
|
169 Participants
n=730 Participants
|
|
Region of Enrollment
Spain
|
35 Participants
n=365 Participants
|
35 Participants
n=365 Participants
|
70 Participants
n=730 Participants
|
|
Region of Enrollment
United States
|
74 Participants
n=365 Participants
|
74 Participants
n=365 Participants
|
148 Participants
n=730 Participants
|
|
HemoglobinA1c (HbA1c)
|
8.17 Percentage of HbA1c
STANDARD_DEVIATION 0.83 • n=361 Participants • All participants who received at least one dose of study drug and had baseline HbA1c value.
|
8.18 Percentage of HbA1c
STANDARD_DEVIATION 0.79 • n=362 Participants • All participants who received at least one dose of study drug and had baseline HbA1c value.
|
8.18 Percentage of HbA1c
STANDARD_DEVIATION 0.81 • n=723 Participants • All participants who received at least one dose of study drug and had baseline HbA1c value.
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of study drug and had at least one post-baseline HbA1c data.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=361 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=362 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]
|
-1.01 Percentage of HbA1c
Standard Error 0.0463
|
-1.00 Percentage of HbA1c
Standard Error 0.0463
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of study drug and had at least one post-baseline HbA1c data.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=361 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=362 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Change From Baseline in HbA1c [Superiority]
|
-1.01 Percentage of HbA1c
Standard Error 0.0463
|
-1.00 Percentage of HbA1c
Standard Error 0.0463
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of participants achieving HbA1c \<7% without nocturnal hypoglycemia \[\<54 milligram/deciliter (mg/dL) 3.0 millimole/Liter (mmol/L)\] or severe during treatment phase up to week 26. Nocturnal hypoglycemia is a hypoglycemia event, including severe hypoglycemia, that occurs at night and presumably during sleep between midnight and 6:00 am.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=361 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=362 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Percentage of Participants Achieving HbA1c <7% Without Nocturnal Hypoglycemia
|
38.6 Percentage of participants
|
35.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline Up To Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
The event rate of participant-reported clinically significant nocturnal hypoglycemia, (where glucose \<54 mg/dL (3.0 mmol/L) or severe and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 26. Group mean is reported here.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=365 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=365 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Nocturnal Hypoglycemia Event Rate
|
0.67 Events per year
Standard Error 0.112
|
1.00 Events per year
Standard Error 0.151
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG).
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=361 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=361 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Change From Baseline in Fasting Glucose
|
-30.87 milligrams per deciliter (mg/dL)
Standard Error 1.876
|
-26.58 milligrams per deciliter (mg/dL)
Standard Error 1.871
|
SECONDARY outcome
Timeframe: Week 22 to Week 26Population: All participants who received at least one dose of the study drug and had evaluable data for this outcome.
Percentage of Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=359 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=360 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Percentage of Time in Glucose Range
|
58.39 Percentage of time
Standard Error 0.993
|
57.05 Percentage of time
Standard Error 0.990
|
SECONDARY outcome
Timeframe: Week 22 to Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of Time in hypoglycemia range with glucose \<54 mg/dL (3.0 mmol/L), measured by CGM.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=359 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=360 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Percentage of Time in Hypoglycemia Range
|
6.84 Percentage of time
Standard Error 0.700
|
5.25 Percentage of time
Standard Error 0.680
|
SECONDARY outcome
Timeframe: Week 22 to Week 26Population: All participants who received at least one dose of the study drug and had evaluable data for this outcome.
Percentage of Time in hyperglycemia range with glucose \>180 mg/dL (10.0 mmol/L), measured by CGM.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=359 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=360 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Percentage of Time in Hyperglycemia Range
|
40.10 Percentage of time
Standard Error 1.024
|
41.60 Percentage of time
Standard Error 1.024
|
SECONDARY outcome
Timeframe: Week 22 to Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Glucose variability measured as coefficient of variation for glucose within day for 24-hour period between Week 22 and 26 was reported.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=334 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=341 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Glucose Variability Between Weeks 22 to 26
|
28.51 Coefficient of Variation
Standard Error 0.259
|
28.28 Coefficient of Variation
Standard Error 0.254
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Average weekly basal Insulin Dose at Week 26 was reported.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=360 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=362 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Basal Insulin Dose at Week 26
|
391.59 Units per week of basal insulin
Standard Error 7.482
|
426.62 Units per week of basal insulin
Standard Error 7.323
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of the study drug and had evaluable data for this outcome.
Average daily bolus Insulin Dose at Week 26 was reported.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=275 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=285 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Bolus Insulin Dose at Week 26
|
27.01 Units per day of bolus insulin
Standard Error 1.182
|
34.56 Units per day of bolus insulin
Standard Error 1.156
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Average total weekly insulin dose at Week 26 was reported.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=274 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=285 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Total Insulin Dose at Week 26
|
592.92 Units per week of insulin
Standard Error 12.560
|
666.43 Units per week of insulin
Standard Error 12.144
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of the study drug and had evaluable data for this outcome.
Basal insulin dose to total insulin dose ratio at Week 26 was reported.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=274 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=285 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Basal Insulin Dose to Total Insulin Dose Ratio at Week 26
|
70.09 Ratio
Standard Error 0.749
|
66.55 Ratio
Standard Error 0.722
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Hypoglycemia event rate was reported. Hypoglycemia with glucose \<54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported here.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=365 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=365 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Hypoglycemia Event Rate
|
6.58 Events per year
Standard Error 0.709
|
5.94 Events per year
Standard Error 0.618
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Change from baseline in body weight was reported.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=365 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=363 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Change From Baseline in Body Weight
|
2.67 kilograms (kg)
Standard Error 0.165
|
2.53 kilograms (kg)
Standard Error 0.165
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
The DID-EQ is a self-administered, 10-item questionnaire designed to assess participants' perceptions of diabetes injection delivery systems for diabetes. The Device Characteristic Subscale is comprised of items 1 to 7 which focus on specific characteristics of injection devices. Each item is rated on a four-point Likert scale. Scores are transformed and range from 0 to 100. Higher scores indicate more positive perceptions of injection device characteristics
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=274 Participants
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=286 Participants
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ)
|
88.1 Score on a scale
Standard Error 0.77
|
86.3 Score on a scale
Standard Error 0.75
|
Adverse Events
500 U/mL - Insulin Efsitora
Serious events: 25 serious events
Other events: 35 other events
Deaths: 1 deaths
100 U/mL - Insulin Glargine
Serious events: 24 serious events
Other events: 40 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
500 U/mL - Insulin Efsitora
n=365 participants at risk
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=365 participants at risk
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Cardiac disorders
Angina pectoris
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Cardiac disorders
Atrioventricular block
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Cardiac disorders
Cardiac arrest
|
0.55%
2/365 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Gastrointestinal disorders
Ascites
|
0.27%
1/365 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
General disorders
Chest pain
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
General disorders
Pyrexia
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Diabetic foot infection
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Osteomyelitis
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Pneumonia
|
0.82%
3/365 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Soft tissue infection
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
5/365 • Number of events 5 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
1.4%
5/365 • Number of events 5 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Musculoskeletal and connective tissue disorders
Spinal instability
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.52%
1/193 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/176 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Nervous system disorders
Migraine
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Psychiatric disorders
Acute psychosis
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Psychiatric disorders
Bipolar disorder
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Renal and urinary disorders
Postrenal failure
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Vascular disorders
Hypertensive emergency
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Vascular disorders
Hypotension
|
0.27%
1/365 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
0.00%
0/365 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
Other adverse events
| Measure |
500 U/mL - Insulin Efsitora
n=365 participants at risk
Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
|
100 U/mL - Insulin Glargine
n=365 participants at risk
Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
|
|---|---|---|
|
Infections and infestations
Influenza
|
3.8%
14/365 • Number of events 17 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
5.2%
19/365 • Number of events 20 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
23/365 • Number of events 25 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
5.8%
21/365 • Number of events 23 • Baseline Through Safety Follow-Up (Up To 31 Weeks)
All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60