Trial · NCT04848480
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)
NCT04848480, Phase 3, Completed, Novo Nordisk A/S; results first posted 2025-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT04848480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04848480
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT04848480
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 582 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- insulin icodec, insulin degludec, insulin aspart
- First posted
- 2021-04-19
- Last updated
- 2025-12-04
- Other registries' IDs
- eudract:2020-002374-27
- Results first posted
- 2025-06-12
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Glycosylated Haemoglobin (HbA1c) at Week 26 | Baseline (week 0), 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. |
| Secondary | Change in Glycosylated Haemoglobin (HbA1c) at Week 52 | Baseline (week 0), 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. |
| Secondary | Change in Fasting Plasma Glucose (FPG) | Baseline (week 0), week 26 | 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. |
| Secondary | Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System | From week 22 to week 26 | 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. |
| Secondary | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction | Baseline (week 0), week 26 | 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. |
| Secondary | Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26 | 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. |
| Secondary | Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Glycosylated Haemoglobin (HbA1c) at Week 26 | Baseline (week 0), week 26 | Full analysis set included all randomised participants. | Percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Glycosylated Haemoglobin (HbA1c) at Week 52 | Baseline (week 0), week 52 | Full analysis set included all randomised participants. | Percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) | Baseline (week 0), week 26 | Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data. | millimoles per liter (mmol/l) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System | From week 22 to week 26 | Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data. | Percentage of time | MEAN |
| SECONDARY | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction | Baseline (week 0), week 26 | Full analysis set included all randomised participants. Overall Number of Participants Analyzed = participants with available data. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26 | From baseline (week 0) to week 26 | Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product. | Episodes | NUMBER |
| SECONDARY | Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57 | From baseline (week 0) to week 57 | Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product. | Episodes | NUMBER |
| SECONDARY | 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 | From baseline (week 0) to week 26 | Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product. | Episodes | NUMBER |
| SECONDARY | 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 | From baseline (week 0) to week 57 | Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product. | Episodes | NUMBER |
| SECONDARY | 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 | From baseline (week 0) to week 26 | Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product. | Episodes | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) at Week 26 | Insulin Icodec + Insulin Aspart | -0.47 | Standard Error 0.07 | Percentage of HbA1c | |
| Change in Glycosylated Haemoglobin (HbA1c) at Week 26 | Insulin Degludec + Insulin Aspart | -0.51 | Standard Error 0.06 | Percentage of HbA1c | |
| Change in Glycosylated Haemoglobin (HbA1c) at Week 52 | Insulin Icodec + Insulin Aspart | -0.37 | Standard Error 0.05 | Percentage of HbA1c | |
| Change in Glycosylated Haemoglobin (HbA1c) at Week 52 | Insulin Degludec + Insulin Aspart | -0.54 | Standard Error 0.05 | Percentage of HbA1c | |
| Change in Fasting Plasma Glucose (FPG) | Insulin Icodec + Insulin Aspart | -0.84 | Standard Error 0.20 | millimoles per liter (mmol/l) | |
| Change in Fasting Plasma Glucose (FPG) | Insulin Degludec + Insulin Aspart | -1.87 | Standard Error 0.20 | millimoles per liter (mmol/l) | |
| Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System | Insulin Icodec + Insulin Aspart | 59.10 | Standard Deviation 15.66 | Percentage of time | |
| Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System | Insulin Degludec + Insulin Aspart | 60.85 | Standard Deviation 15.03 | Percentage of time | |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction | Insulin Icodec + Insulin Aspart | 1.97 | Standard Error 0.27 | Score on a scale | |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction | Insulin Degludec + Insulin Aspart | 3.06 | Standard Error 0.27 | Score on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Phase (26 Weeks) | STARTED | Insulin Icodec + Insulin Aspart | 290 | |
| Main Phase (26 Weeks) | STARTED | Insulin Degludec + Insulin Aspart | 292 | |
| Main Phase (26 Weeks) | COMPLETED | Insulin Icodec + Insulin Aspart | 279 | |
| Main Phase (26 Weeks) | COMPLETED | Insulin Degludec + Insulin Aspart | 284 | |
| Main Phase (26 Weeks) | NOT COMPLETED | Insulin Icodec + Insulin Aspart | 11 | |
| Main Phase (26 Weeks) | NOT COMPLETED | Insulin Degludec + Insulin Aspart | 8 | |
| Extension Phase (26 Weeks) | STARTED | Insulin Icodec + Insulin Aspart | 279 | |
| Extension Phase (26 Weeks) | STARTED | Insulin Degludec + Insulin Aspart | 284 | |
| Extension Phase (26 Weeks) | COMPLETED | Insulin Icodec + Insulin Aspart | 274 | |
| Extension Phase (26 Weeks) | COMPLETED | Insulin Degludec + Insulin Aspart | 281 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Insulin Icodec + Insulin Aspart | 12 | 290 | 13 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Insulin Degludec + Insulin Aspart | 15 | 292 | 16 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Insulin Icodec + Insulin Aspart | 5 | 290 | 5 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Insulin Degludec + Insulin Aspart | 17 | 292 | 31 |
| other | COVID-19 | Infections and infestations | Insulin Icodec + Insulin Aspart | 74 | 290 | 80 |
| other | COVID-19 | Infections and infestations | Insulin Degludec + Insulin Aspart | 83 | 292 | 88 |
| other | Diabetic retinopathy | Eye disorders | Insulin Icodec + Insulin Aspart | 24 | 290 | 28 |
| other | Diabetic retinopathy | Eye disorders | Insulin Degludec + Insulin Aspart | 26 | 292 | 29 |
| other | Headache | Nervous system disorders | Insulin Icodec + Insulin Aspart | 17 | 290 | 27 |
| other | Headache | Nervous system disorders | Insulin Degludec + Insulin Aspart | 16 | 292 | 22 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Insulin Icodec + Insulin Aspart | 1 | 290 |
| Total, all-cause mortality | Insulin Degludec + Insulin Aspart | 0 | 292 |
| Total, other adverse events | Insulin Icodec + Insulin Aspart | 145 | 290 |
| Total, other adverse events | Insulin Degludec + Insulin Aspart | 162 | 292 |
| Total, serious adverse events | Insulin Icodec + Insulin Aspart | 24 | 290 |
| Total, serious adverse events | Insulin Degludec + Insulin Aspart | 20 | 292 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Insulin Icodec + Insulin Aspart vs Insulin Degludec + Insulin Aspart: deaths from any cause | Trial comparisons |
| Insulin Icodec + Insulin Aspart vs Insulin Degludec + Insulin Aspart: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04848480
GET https://conductscience.org/api/trials/v1/NCT04848480/results?page=2