Trial Outcomes & Findings for A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before (NCT NCT04460885)
NCT ID: NCT04460885
Last Updated: 2025-12-04
Results Overview
Change in HbA1c from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
984 participants
Primary outcome timeframe
Baseline (week 0), Week 52
Results posted on
2025-12-04
Participant Flow
The trial was conducted at 137 sites in 12 countries while 141 sites screened participants. The total number of sites per country that screened and randomised participants are as follows (number of sites that screened participants/number of sites that randomised participants): Croatia (4/4), India (9/9), Israel (5/5), Italy (5/5), Japan (14/14), Mexico (3/3), Poland (8/8), Russia (14/14), Slovakia (7/7), Spain (5/5), United Kingdom (11/11), United States (56/52)
Participant milestones
| Measure |
Insulin Icodec
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Overall Study
STARTED
|
492
|
492
|
|
Overall Study
Full Analysis Set
|
492
|
492
|
|
Overall Study
Safety Analysis Set
|
492
|
492
|
|
Overall Study
COMPLETED
|
474
|
475
|
|
Overall Study
NOT COMPLETED
|
18
|
17
|
Reasons for withdrawal
| Measure |
Insulin Icodec
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
|
Overall Study
Site closure
|
1
|
0
|
|
Overall Study
Death
|
5
|
4
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before
Baseline characteristics by cohort
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
Total
n=984 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.06 Years
STANDARD_DEVIATION 10.05 • n=3 Participants
|
58.85 Years
STANDARD_DEVIATION 9.85 • n=3 Participants
|
58.96 Years
STANDARD_DEVIATION 9.95 • n=6 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=3 Participants
|
229 Participants
n=3 Participants
|
426 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
295 Participants
n=3 Participants
|
263 Participants
n=3 Participants
|
558 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
53 Participants
n=3 Participants
|
53 Participants
n=3 Participants
|
106 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
439 Participants
n=3 Participants
|
439 Participants
n=3 Participants
|
878 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
129 Participants
n=3 Participants
|
145 Participants
n=3 Participants
|
274 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=3 Participants
|
17 Participants
n=3 Participants
|
27 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
333 Participants
n=3 Participants
|
317 Participants
n=3 Participants
|
650 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 Participants
n=3 Participants
|
13 Participants
n=3 Participants
|
29 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), Week 52Population: Full analysis set included all randomized participants.
Change in HbA1c from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above.
Outcome measures
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Change in Glycated Haemoglobin (HbA1c)
|
-1.55 Percentage of HbA1c
Standard Error 0.06
|
-1.35 Percentage of HbA1c
Standard Error 0.05
|
SECONDARY outcome
Timeframe: From week 48 to week 52Population: Full analysis set included all randomized participants. Overall number of participants analysed = Participants with available data for the outcome measure.
Percentage of time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using CGM system from week 48 to week 52 is presented. Time in target range is defined as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above.
Outcome measures
| Measure |
Insulin Icodec
n=439 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=440 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System
|
71.94 Percentage of time
Standard Deviation 18.23
|
66.90 Percentage of time
Standard Deviation 18.19
|
SECONDARY outcome
Timeframe: Baseline (week 0), Week 52Population: Full analysis set included all randomized participants. Overall number of participants analysed = Participants with available data for the outcome measure.
Change in FPG from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above.
Outcome measures
| Measure |
Insulin Icodec
n=480 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=474 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-3.35 millimoles per liter (mmol/L)
Standard Error 0.09
|
-3.33 millimoles per liter (mmol/L)
Standard Error 0.09
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 52Population: Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.
Outcome measures
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 52
|
1 Episodes
|
3 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 52Population: Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.
Outcome measures
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 mg/dL] Confirmed by Blood Glucose [BG] Meter) Until Week 52
|
143 Episodes
|
75 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 52Population: Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.
Outcome measures
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) Until Week 52
|
144 Episodes
|
78 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 83Population: Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a subject was considered exposed to trial product.
Outcome measures
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 83
|
1 Episodes
|
7 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 83Population: Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a subject was considered exposed to trial product.
Outcome measures
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL) Confirmed by BG Meter) Until Week 83
|
226 Episodes
|
114 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 83Population: Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. On-treatment period started at the date of first dose of trial product as recorded on the eCRF and ended at the first date of any of the following: The end of trial visit (V63), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. On-treatment period was the period in which a participant was exposed to trial product.
Outcome measures
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) Until Week 83
|
227 Episodes
|
121 Episodes
|
SECONDARY outcome
Timeframe: From week 50 to week 52Population: Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
Mean weekly insulin dose from week 50 to week 52 is presented. The outcome data was evaluated based on main on treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit, the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.
Outcome measures
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Mean Weekly Insulin Dose
|
214.23 Units of insulin
Interval 202.18 to 227.0
|
222.39 Units of insulin
Interval 209.93 to 235.59
|
SECONDARY outcome
Timeframe: Baseline (week 0), Week 52Population: Full analysis set included all randomized participants.
Change in body weight from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above.
Outcome measures
| Measure |
Insulin Icodec
n=492 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Change in Body Weight
|
2.29 kilograms (kg)
Standard Error 0.21
|
1.83 kilograms (kg)
Standard Error 0.21
|
SECONDARY outcome
Timeframe: From week 48 to week 52Population: Full analysis set included all randomized participants. Overall number of participants analyzed=Participants with available data for the outcome measure.
Percentage of time spent \< 3.0 mmol/L (54 mg/dL) from week 48 to week 52 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above.
Outcome measures
| Measure |
Insulin Icodec
n=439 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=440 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System
|
0.27 Percentage of time
Standard Deviation 0.57
|
0.21 Percentage of time
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: From week 48 to week 52Population: Full analysis set included all randomized participants. Overall number of participants analyzed=Participants with available data for the outcome measure.
Percentage of time spent \> 10 mmol/L (180 mg/dL) is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above.
Outcome measures
| Measure |
Insulin Icodec
n=439 Participants
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=440 Participants
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System
|
26.86 Percentage of time
Standard Deviation 18.74
|
32.27 Percentage of time
Standard Deviation 18.66
|
Adverse Events
Insulin Icodec
Serious events: 64 serious events
Other events: 221 other events
Deaths: 5 deaths
Insulin Glargine
Serious events: 71 serious events
Other events: 216 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Insulin Icodec
n=492 participants at risk
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 participants at risk
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.81%
4/492 • Number of events 4 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
1.0%
5/492 • Number of events 5 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Angina pectoris
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Angina unstable
|
0.81%
4/492 • Number of events 4 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
5/492 • Number of events 5 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Atrial flutter
|
0.20%
1/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Atrial thrombosis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Vascular disorders
Brachiocephalic arteriosclerosis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
COVID-19
|
0.81%
4/492 • Number of events 4 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.61%
3/492 • Number of events 3 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.81%
4/492 • Number of events 4 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Cardiac failure
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Eye disorders
Cataract
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Cellulitis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Chronic coronary syndrome
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Chronic hepatitis C
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Coronary artery disease
|
0.81%
4/492 • Number of events 4 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Deafness traumatic
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
General disorders
Death
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Metabolism and nutrition disorders
Electrolyte depletion
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Empyema
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Erysipelas
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Vascular disorders
Haematoma
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Investigations
Hepatic enzyme increased
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Vascular disorders
Hypertensive urgency
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Intestinal sepsis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Nervous system disorders
Ischaemic stroke
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Renal and urinary disorders
Ketonuria
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Myocardial infarction
|
0.61%
3/492 • Number of events 3 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.61%
3/492 • Number of events 3 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Myxoid cyst
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
General disorders
Oedema peripheral
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Eye disorders
Open angle glaucoma
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.61%
3/492 • Number of events 3 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Osteomyelitis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.20%
1/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Pneumonia
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.61%
3/492 • Number of events 3 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Post procedural stroke
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Ear and labyrinth disorders
Presbyacusis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Psychiatric disorders
Psychotic disorder
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Surgical and medical procedures
Removal of foreign body
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Sepsis
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Sinus tachycardia
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Investigations
Troponin increased
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.41%
2/492 • Number of events 3 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/492 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
Other adverse events
| Measure |
Insulin Icodec
n=492 participants at risk
Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 units.
|
Insulin Glargine
n=492 participants at risk
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: \< 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and \>7.2 mmol/L: dose was increased by 3 U.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
30/492 • Number of events 36 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
4.5%
22/492 • Number of events 28 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
40/492 • Number of events 42 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
6.5%
32/492 • Number of events 34 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
COVID-19
|
17.7%
87/492 • Number of events 91 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
20.5%
101/492 • Number of events 108 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Eye disorders
Diabetic retinopathy
|
7.3%
36/492 • Number of events 41 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
6.5%
32/492 • Number of events 38 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.9%
39/492 • Number of events 54 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
5.3%
26/492 • Number of events 29 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
38/492 • Number of events 50 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
9.6%
47/492 • Number of events 56 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
General disorders
Pyrexia
|
5.5%
27/492 • Number of events 30 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
4.7%
23/492 • Number of events 27 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
28/492 • Number of events 40 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
4.5%
22/492 • Number of events 24 • From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER