A Phase 3 interventional study of insulin icodec and insulin degludec in Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 130 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes.
The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.
Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin.
The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.
The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken.
At 6 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.
Participants will be asked to wear a sensor that measures your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year).
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 582 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.
Drug: insulin icodec · Drug: insulin aspart
insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times.
Drug: insulin degludec · Drug: insulin aspart
insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly
insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily
insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily
Change in Glycosylated Haemoglobin (HbA1c) at Week 26
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.
Time frame: Baseline (week 0), week 26
Change in Glycosylated Haemoglobin (HbA1c) at Week 52
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.
Time frame: Baseline (week 0), week 52
Change in Fasting Plasma Glucose (FPG)
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.
Time frame: Baseline (week 0), week 26
Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System
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.
Time frame: From week 22 to week 26
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction
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.
Time frame: Baseline (week 0), week 26
Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26
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.
Time frame: From baseline (week 0) to week 26
Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57
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.
Time frame: From baseline (week 0) to week 57
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
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.
Time frame: From baseline (week 0) to week 26
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
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.
Time frame: From baseline (week 0) to week 57
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
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.
Time frame: From baseline (week 0) to week 26
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
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.
Time frame: From baseline (week 0) to week 57
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
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.
Time frame: From baseline (week 0) to week 26
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
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.
Time frame: From baseline (week 0) to week 57
Percentage of Time Spent Less Than (<) 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System
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.
Time frame: From week 22 to week 26
Percentage of Time Spent Greater Than (>) 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System
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.
Time frame: From week 22 to week 26
Mean Total Weekly Insulin Dose: From Week 24 to Week 26
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.
Time frame: From week 24 to week 26
Mean Total Weekly Insulin Dose: From Week 50 to Week 52
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.
Time frame: From week 50 to week 52
Change in Body Weight
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.
Time frame: Baseline (week 0), week 26
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).
| Milestone | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Started | 290 | 292 |
| Completed | 279 | 284 |
| Not completed | 11 | 8 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 9 | 7 |
| Milestone | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Started | 279 | 284 |
| Completed | 274 | 281 |
| Not completed | 5 | 3 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 4 | 2 |
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.
| Percentage of HbA1c | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) at Week 26 | -0.47 ± 0.07 | -0.51 ± 0.06 |
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.
| Percentage of HbA1c | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) at Week 52 | -0.37 ± 0.05 | -0.54 ± 0.05 |
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.
| millimoles per liter (mmol/l) | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | -0.84 ± 0.20 | -1.87 ± 0.20 |
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.
| Percentage of time | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| 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 ± 15.66 | 60.85 ± 15.03 |
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.
| Score on a scale | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction | 1.97 ± 0.27 | 3.06 ± 0.27 |
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.
| Episodes | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26 | 47 | 17 |
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.
| Episodes | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57 | 56 | 25 |
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.
| Episodes | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| 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 | 1478 |
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.
| Episodes | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| 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 | 2811 |
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.
| Episodes | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| 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 | 1495 |
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.
| Episodes | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| 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 | 2836 |
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.
| Episodes | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| 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 | 227 |
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.
| Episodes | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| 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 | 462 |
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.
| Percentage of time | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Percentage of Time Spent Less Than (<) 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System | 1.02 ± 1.64 | 0.68 ± 1.27 |
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.
| Percentage of time | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Percentage of Time Spent Greater Than (>) 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | 37.03 ± 16.21 | 36.25 ± 15.61 |
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.
| Units of insulin | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Mean Total Weekly Insulin Dose: From Week 24 to Week 26 | 310.52 (295.70 to 326.08) | 322.68 (307.46 to 338.66) |
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.
| Units of insulin | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Mean Total Weekly Insulin Dose: From Week 50 to Week 52 | 310.14 (294.85 to 326.22) | 328.90 (312.86 to 345.75) |
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.
| kilograms | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| Change in Body Weight | 1.29 ± 0.23 | 1.01 ± 0.23 |
Collected over Week 1 to week 57. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Icodec + Insulin Aspart | 1/290 (0.3%) | 24/290 (8.3%) | 145/290 (50%) |
| Insulin Degludec + Insulin Aspart | 0/292 (0%) | 20/292 (6.8%) | 162/292 (55.5%) |
| Event | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 8/290 | 1/292 |
| Angina unstableCardiac disorders | 0/290 | 2/292 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/290 | 0/292 |
| Abortion threatenedPregnancy, puerperium and perinatal conditions | 1/290 | 0/292 |
| Acute kidney injuryRenal and urinary disorders | 1/290 | 0/292 |
| Acute myocardial infarctionCardiac disorders | 1/290 | 0/292 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/290 | 0/292 |
| Ankle fractureInjury, poisoning and procedural complications | 1/290 | 0/292 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 1/290 | 0/292 |
| COVID-19Infections and infestations | 1/290 | 1/292 |
| Event | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart |
|---|---|---|
| COVID-19Infections and infestations | 74/290 | 83/292 |
| NasopharyngitisInfections and infestations | 48/290 | 61/292 |
| Diabetic retinopathyEye disorders | 24/290 | 26/292 |
| PyrexiaGeneral disorders | 16/290 | 20/292 |
| HeadacheNervous system disorders | 17/290 | 16/292 |
| Back painMusculoskeletal and connective tissue disorders | 5/290 | 17/292 |
| Upper respiratory tract infectionInfections and infestations | 15/290 | 11/292 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 12/290 | 15/292 |
Full analysis set included all randomized participants.
| Age, Continuous(years) | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart | Total |
|---|---|---|---|
| Mean | 44.08 ± 14.07 | 44.28 ± 14.07 | 44.18 ± 14.06 |
| Sex: Female, Male(Participants) | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart | Total |
|---|---|---|---|
| Female | 125 | 120 | 245 |
| Male | 165 | 172 | 337 |
| Ethnicity (NIH/OMB)(Participants) | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 10 | 20 |
| Not Hispanic or Latino | 280 | 282 | 562 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Insulin Icodec + Insulin Aspart | Insulin Degludec + Insulin Aspart | Total |
|---|---|---|---|
| Race — Asian | 51 | 72 | 123 |
| Race — Black Or African American | 9 | 2 | 11 |
| Race — White | 230 | 218 | 448 |
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