Trial · NCT05352815
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
NCT05352815, Phase 3, Completed, Novo Nordisk A/S; results first posted 2025-04-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec. Trials, record NCT05352815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05352815
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
- NCT number
- NCT05352815
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,291 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- IcoSema, Insulin icodec
- First posted
- 2022-04-29
- Last updated
- 2025-12-04
- Other registries' IDs
- eudract:2020-005281-34
- Results first posted
- 2025-04-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Glycated Haemoglobin (HbA1c) | Baseline (Week 0), Week 52 | Change from baseline (week 0) to week 52 in HbA1c is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above. |
| Secondary | Change in Body Weight | Baseline (Week 0), Week 52 | Change from baseline (week 0) to week 52 in body weight is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above. |
| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3) | From baseline week 0 to week 57 | Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (\<) 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets. |
| Secondary | Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | From week 48 to week 52 | Time in range was defined as 100 times the number of recorded measurements in glycemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above. |
| Secondary | Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | From week 48 to week 52 | Time spent below threshold was defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above. |
| Secondary | Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | From week 48 to week 52 | Time spent above threshold is defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above. |
| Secondary | Change in Fasting Plasma Glucose (FPG) | Baseline (Week 0), Week 52 | Change in FPG from baseline (week 0) to week 52 is presented. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above. |
| Secondary | Weekly Basal Insulin Dose | From week 50 to week 52 | Estimated mean average weekly basal insulin dose from week 50 to week 52 of treatment is presented. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets. |
| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) | From baseline week 0 to week 57 | Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (\<) 3.0 mmol/L (54 mg/dL). The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets. |
| Secondary | Number of Severe Hypoglycaemic Episodes (Level 3) | From baseline week 0 to week 57 | Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Glycated Haemoglobin (HbA1c) | Baseline (Week 0), Week 52 | Full Analysis Set (FAS) included all randomised participants. Overall number of participants analyzed = participants with available data. | Percentage point of HbA1c | MEAN |
| SECONDARY | Change in Body Weight | Baseline (Week 0), Week 52 | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Kilogram (Kg) | MEAN |
| SECONDARY | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3) | From baseline week 0 to week 57 | Safety analysis set (SAS) included all randomised participants who are exposed to randomised treatment. | Episodes | NUMBER |
| SECONDARY | Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | From week 48 to week 52 | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Percentage of time | MEAN |
| SECONDARY | Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | From week 48 to week 52 | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Percentage of time | MEAN |
| SECONDARY | Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | From week 48 to week 52 | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Percentage of time | MEAN |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) | Baseline (Week 0), Week 52 | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Millimoles per litre (mmol/L) | MEAN |
| SECONDARY | Weekly Basal Insulin Dose | From week 50 to week 52 | SAS included all randomised participants who are exposed to randomised treatment. Overall number of participants analyzed = participants with available data. | Units of insulin | MEAN |
| SECONDARY | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) | From baseline week 0 to week 57 | SAS included all randomised participants who are exposed to randomised treatment. | Episodes | NUMBER |
| SECONDARY | Number of Severe Hypoglycaemic Episodes (Level 3) | From baseline week 0 to week 57 | SAS included all randomised participants who are exposed to randomised treatment. | Episodes | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | IcoSema | -1.60 | Standard Deviation 0.99 | Percentage point of HbA1c | |
| Change in Glycated Haemoglobin (HbA1c) | Insulin Icodec | -0.90 | Standard Deviation 1.01 | Percentage point of HbA1c | |
| Change in Body Weight | IcoSema | -3.71 | Standard Deviation 4.87 | Kilogram (Kg) | |
| Change in Body Weight | Insulin Icodec | 1.96 | Standard Deviation 4.76 | Kilogram (Kg) | |
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3) | IcoSema | 91 | Episodes | ||
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3) | Insulin Icodec | 424 | Episodes | ||
| Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | IcoSema | 75.9 | Standard Deviation 16.1 | Percentage of time | |
| Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | Insulin Icodec | 61.9 | Standard Deviation 18.1 | Percentage of time | |
| Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | IcoSema | 0.27 | Standard Deviation 0.55 | Percentage of time | |
| Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | Insulin Icodec | 0.33 | Standard Deviation 0.82 | Percentage of time |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IcoSema | 646 | |
| Overall Study | STARTED | Insulin Icodec | 645 | |
| Overall Study | Treated | IcoSema | 644 | |
| Overall Study | Treated | Insulin Icodec | 644 | |
| Overall Study | Full Analysis Set | IcoSema | 646 | |
| Overall Study | Full Analysis Set | Insulin Icodec | 645 | |
| Overall Study | Safety Analysis Set | IcoSema | 644 | |
| Overall Study | Safety Analysis Set | Insulin Icodec | 644 | |
| Overall Study | COMPLETED | IcoSema | 611 | |
| Overall Study | COMPLETED | Insulin Icodec | 611 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events302
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 | COVID-19 | Infections and infestations | Icodec | 61 | 644 | 62 |
| other | COVID-19 | Infections and infestations | IcoSema | 67 | 644 | 68 |
| other | Constipation | Gastrointestinal disorders | Icodec | 8 | 644 | 8 |
| other | Constipation | Gastrointestinal disorders | IcoSema | 39 | 644 | 55 |
| other | Decreased appetite | Metabolism and nutrition disorders | Icodec | 1 | 644 | 1 |
| other | Decreased appetite | Metabolism and nutrition disorders | IcoSema | 38 | 644 | 48 |
| other | Diabetic retinopathy | Eye disorders | Icodec | 35 | 644 | 41 |
| other | Diabetic retinopathy | Eye disorders | IcoSema | 41 | 644 | 46 |
| other | Diarrhoea | Gastrointestinal disorders | Icodec | 46 | 644 | 65 |
| other | Diarrhoea | Gastrointestinal disorders | IcoSema | 102 | 644 | 187 |
1 to 10 of 302Source ClinicalTrials.gov
See all 302 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Icodec | 3 | 645 |
| Total, all-cause mortality | IcoSema | 2 | 646 |
| Total, other adverse events | Icodec | 258 | 644 |
| Total, other adverse events | IcoSema | 354 | 644 |
| Total, serious adverse events | Icodec | 69 | 644 |
| Total, serious adverse events | IcoSema | 59 | 644 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|
| Icodec vs IcoSema: deaths from any cause | Trial comparisons |
| Icodec vs IcoSema: 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/NCT05352815
GET https://conductscience.org/api/trials/v1/NCT05352815/events?page=2