Trial Outcomes & Findings for A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6) (NCT NCT04848480)

NCT ID: NCT04848480

Last Updated: 2025-12-04

Results Overview

Change in HbA1c from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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: 582 participants
• Primary outcome timeframe: Baseline (week 0), week 26
• Results posted on: 2025-12-04

Participant Flow

The trial was conducted at 97 sites in 12 countries as follows (number of sites that screened subjects/ number of sites that randomized subject): Austria-(6/6), Canada-(5/5), Germany-(8/8), India-(6/6), Italy-(5/5), Japan-(7/7), Netherlands-(3/3), Russia-(10/10), Spain-(4/4), Turkey-(7/7), United Kingdom-(8/8), United States-(29/28).

This was a 52-week trial. The first 26 weeks of the trial constituted the main phase which was followed by a 26-week extension phase with focus on evaluating long term safety and provide long-term exposure data.

Participant milestones

Measure	Insulin Icodec + Insulin Aspart Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Main Phase (26 Weeks) STARTED	290	292
Main Phase (26 Weeks) COMPLETED	279	284
Main Phase (26 Weeks) NOT COMPLETED	11	8
Extension Phase (26 Weeks) STARTED	279	284
Extension Phase (26 Weeks) COMPLETED	274	281
Extension Phase (26 Weeks) NOT COMPLETED	5	3

Reasons for withdrawal

Measure	Insulin Icodec + Insulin Aspart Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Main Phase (26 Weeks) Death	1	0
Main Phase (26 Weeks) Lost to Follow-up	1	1
Main Phase (26 Weeks) Withdrawal by Subject	9	7
Extension Phase (26 Weeks) Physician Decision	1	0
Extension Phase (26 Weeks) Lost to Follow-up	0	1
Extension Phase (26 Weeks) Withdrawal by Subject	4	2

Baseline Characteristics

A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)

Baseline characteristics by cohort

Measure	Insulin Icodec + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.	Total n=582 Participants Total of all reporting groups
Age, Continuous	44.08 years STANDARD_DEVIATION 14.07 • n=3 Participants	44.28 years STANDARD_DEVIATION 14.07 • n=3 Participants	44.18 years STANDARD_DEVIATION 14.06 • n=6 Participants
Sex: Female, Male Female	125 Participants n=3 Participants	120 Participants n=3 Participants	245 Participants n=6 Participants
Sex: Female, Male Male	165 Participants n=3 Participants	172 Participants n=3 Participants	337 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=3 Participants	10 Participants n=3 Participants	20 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	280 Participants n=3 Participants	282 Participants n=3 Participants	562 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 Race · Asian	51 Participants n=3 Participants	72 Participants n=3 Participants	123 Participants n=6 Participants
Race/Ethnicity, Customized Race · Black Or African American	9 Participants n=3 Participants	2 Participants n=3 Participants	11 Participants n=6 Participants
Race/Ethnicity, Customized Race · White	230 Participants n=3 Participants	218 Participants n=3 Participants	448 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), week 26

Population: Full analysis set included all randomised participants.

Change in HbA1c from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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 + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Change in Glycosylated Haemoglobin (HbA1c) at Week 26	-0.47 Percentage of HbA1c Standard Error 0.07	-0.51 Percentage of HbA1c Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: Full analysis set included all randomised participants.

Change in HbA1c from baseline to week 52 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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 + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Change in Glycosylated Haemoglobin (HbA1c) at Week 52	-0.37 Percentage of HbA1c Standard Error 0.05	-0.54 Percentage of HbA1c Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline (week 0), week 26

Population: Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data.

Change in FPG from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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 + Insulin Aspart n=276 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=287 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Change in Fasting Plasma Glucose (FPG)	-0.84 millimoles per liter (mmol/l) Standard Error 0.20	-1.87 millimoles per liter (mmol/l) Standard Error 0.20

SECONDARY outcome

Timeframe: From week 22 to week 26

Population: Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data.

Percentage of time in range 3.9-10.0 mmol/L (70-180 mg/dL) using CGM system from week 22 to week 26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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 + Insulin Aspart n=261 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=272 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System	59.10 Percentage of time Standard Deviation 15.66	60.85 Percentage of time Standard Deviation 15.03

SECONDARY outcome

Timeframe: Baseline (week 0), week 26

Population: Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data.

Change in DTSQs in total treatment satisfaction from baseline to week 26 is presented. The sum score for DTSQ in total treatment satisfaction was calculated by adding the six item scores of items 1, 4, 5, 6, 7 and 8. The sum score for DTSQ can range from 0 to 36, with 0 being the lowest and 36 being the highest score in total treatment satisfaction. Higher scores on the DTSQ total score indicate higher treatment satisfaction. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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 + Insulin Aspart n=288 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=291 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction	1.97 Score on a scale Standard Error 0.27	3.06 Score on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: From baseline (week 0) to week 26

Population: Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product.

Number of severe hypoglycaemic episodes (level 3) from baseline to week 26 are presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: the end date of the on-treatment period; week 26. On-treatment: 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. Data reflects total number of episodes across all participants within the arm.

Outcome measures

Measure	Insulin Icodec + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26	47 Episodes	17 Episodes

SECONDARY outcome

Timeframe: From baseline (week 0) to week 57

Population: Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product.

Number of severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.

Outcome measures

Measure	Insulin Icodec + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57	56 Episodes	25 Episodes

SECONDARY outcome

Timeframe: From baseline (week 0) to week 26

Population: Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product.

Number of clinically significant hypoglycaemic episodes (level 2) from baseline to week 26 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Data is reported for 'main-on-treatment' period. The main-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 date of the on-treatment period; week 26. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.

Outcome measures

Measure	Insulin Icodec + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by Blood Glucose [BG] Meter): From Baseline (Week 0) to Week 26	2789 Episodes	1478 Episodes

SECONDARY outcome

Timeframe: From baseline (week 0) to week 57

Population: Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product.

Number of clinically significant hypoglycaemic episodes (level 2) from baseline to week 57 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Data is reported for 'on-treatment' period. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.

Outcome measures

Measure	Insulin Icodec + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by BG Meter): From Baseline (Week 0) to Week 57	5047 Episodes	2811 Episodes

SECONDARY outcome

Timeframe: From baseline (week 0) to week 26

Population: Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product.

Number of clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 26 presented. Clinically significant hypoglycaemia (level 2) is de-fined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypo-glycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring ex-ternal assistance for recovery. Data is reported for 'main-on-treatment' period, started at date of first dose of trial product as recorded on eCRF, and ended at first date of any of following: end date of on-treatment period; week 26. On-treatment period: Onset date on or after the first dose of trial product and no later than 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. Data reflects total number of episodes across all participants within the arm.

Outcome measures

Measure	Insulin Icodec + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26	2836 Episodes	1495 Episodes

SECONDARY outcome

Timeframe: From baseline (week 0) to week 57

Population: Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product.

Number of clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.

Outcome measures

Measure	Insulin Icodec + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57	5103 Episodes	2836 Episodes

SECONDARY outcome

Timeframe: From baseline (week 0) to week 26

Population: Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product.

Number of nocturnal clinically significant hypoglycaemic episodes (level 2) or severe hypogly-caemic episodes (level 3) from baseline to week 26 presented. Nocturnal: Period between 00:01 and 05:59 (both included). Clinically significant hypoglycaemia (level 2): Plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3): Hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period, started at date of first dose of trial product as recorded on eCRF, and ended at first date of any of following: end date of on-treatment period; week 26. On-treatment period: Onset date on or after first dose of trial product and no later than first date of either fol-low-up visit, last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or end-date for in-trial period. Data reflects total number of episodes across all participants within the arm.

Outcome measures

Measure	Insulin Icodec + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Number of Nocturnal Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26	481 Episodes	227 Episodes

SECONDARY outcome

Timeframe: From baseline (week 0) to week 57

Population: Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product.

Number of nocturnal clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Nocturnal: The period between 00:01 and 05:59 (both included). Clinically significant hypoglycaemia (level 2): Plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3): Hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.

Outcome measures

Measure	Insulin Icodec + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Number of Nocturnal Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57	870 Episodes	462 Episodes

SECONDARY outcome

Timeframe: From week 22 to week 26

Population: Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data.

Percentage of time spent < 3.0 mmol/L using CGM system from week 22 to week 26 is presented. Time spent below threshold (< 3.0 mmol/L [54 mg/dL]) was defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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 + Insulin Aspart n=261 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=272 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Percentage of Time Spent Less Than (<) 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System	1.02 Percentage of time Standard Deviation 1.64	0.68 Percentage of time Standard Deviation 1.27

SECONDARY outcome

Timeframe: From week 22 to week 26

Population: Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data.

Percentage of time spent > 10 mmol/L using CGM system from week 22 to week 26 is presented. Time spent above threshold (> 10 mmol/L [180 mg/dL]) was defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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 + Insulin Aspart n=261 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=272 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Percentage of Time Spent Greater Than (>) 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System	37.03 Percentage of time Standard Deviation 16.21	36.25 Percentage of time Standard Deviation 15.61

SECONDARY outcome

Timeframe: From week 24 to week 26

Population: Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data.

Mean total weekly insulin dose from week 24 to week 26 is presented. Data is reported for 'main-on-treatment' period. The main-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 date of the on-treatment period; week 26. The on-treatment period: 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 + Insulin Aspart n=274 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=271 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Mean Total Weekly Insulin Dose: From Week 24 to Week 26	310.52 Units of insulin Interval 295.7 to 326.08	322.68 Units of insulin Interval 307.46 to 338.66

SECONDARY outcome

Timeframe: From week 50 to week 52

Population: Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data.

Mean total weekly insulin dose from week 50 to week 52 is presented. Data is reported for 'on-treatment' period. The on-treatment period: 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 + Insulin Aspart n=273 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=269 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Mean Total Weekly Insulin Dose: From Week 50 to Week 52	310.14 Units of insulin Interval 294.85 to 326.22	328.90 Units of insulin Interval 312.86 to 345.75

SECONDARY outcome

Timeframe: Baseline (week 0), week 26

Population: Full analysis set included all randomised participants.

Change in body weight from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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 + Insulin Aspart n=290 Participants Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 Participants Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Change in Body Weight	1.29 kilograms Standard Error 0.23	1.01 kilograms Standard Error 0.23

Adverse Events

Insulin Icodec + Insulin Aspart

Serious events: 24 serious events

Other events: 145 other events

Deaths: 1 deaths

Insulin Degludec + Insulin Aspart

Serious events: 20 serious events

Other events: 162 other events

Deaths: 0 deaths

Serious adverse events

Measure	Insulin Icodec + Insulin Aspart n=290 participants at risk Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 participants at risk Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Alcohol abuse	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.68% 2/292 • Number of events 2 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Ankle fracture	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Asthenia	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Blood glucose fluctuation	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Blood glucose increased	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 artery stenosis	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Cardiac ablation	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Cystitis escherichia	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Diabetic ketoacidosis	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 seizure	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Haemorrhage intracranial	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Haemorrhoids	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Hypertension	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 crisis	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	2.8% 8/290 • Number of events 13 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Hypokalaemia	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Hypotension	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Influenza	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Ligament rupture	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Lumbar hernia	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Major depression	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Medical device site dermatitis	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 ischaemia	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Obesity	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Optic neuritis	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Proctitis ulcerative	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Product administration error	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Pyelonephritis acute	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 tract infection viral	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Rotator cuff syndrome	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Tendon rupture	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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) Uterine leiomyoma	0.00% 0/290 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	0.34% 1/292 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	0.34% 1/290 • Number of events 1 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 0/292 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 + Insulin Aspart n=290 participants at risk Participants received Insulin icodec along with Insulin aspart for 52 weeks subcutaneously. Participants received once weekly subcutaneous (s.c.) injection of Insulin icodec using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% or 100% of their 7 times total daily basal insulin dose depending on insulin regime and HbA1c level. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Insulin Degludec + Insulin Aspart n=292 participants at risk Participants received Insulin degludec along with Insulin aspart for 52 weeks subcutaneously. Participants received once daily s.c. injection of Insulin degludec using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured weekly.
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 12/290 • Number of events 13 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	5.1% 15/292 • Number of events 16 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	1.7% 5/290 • Number of events 5 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	5.8% 17/292 • Number of events 31 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	25.5% 74/290 • Number of events 80 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	28.4% 83/292 • Number of events 88 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	8.3% 24/290 • Number of events 28 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	8.9% 26/292 • Number of events 29 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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 Headache	5.9% 17/290 • Number of events 27 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	5.5% 16/292 • Number of events 22 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	16.6% 48/290 • Number of events 75 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	20.9% 61/292 • Number of events 84 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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% 16/290 • Number of events 22 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	6.8% 20/292 • Number of events 25 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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	5.2% 15/290 • Number of events 18 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.	3.8% 11/292 • Number of events 13 • Week 1 to week 57 Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V56, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date 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

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

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