Trial Outcomes & Findings for 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 NCT05352815)

Last Updated: 2025-12-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1291 participants

Primary outcome timeframe

Baseline (Week 0), Week 52

Results posted on

2025-12-04

Participant Flow

The trial was conducted at 192 sites in 20 countries.

Participants with type 2 diabetes (T2D) inadequately controlled with daily basal insulin were randomised in 1:1 ratio to receive subcutaneous (s.c.) injection of IcoSema or insulin icodec once weekly with or without oral anti-diabetic drugs (OADs).

Participant milestones

Participant milestones
Measure	IcoSema Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Overall Study STARTED	646	645
Overall Study Treated	644	644
Overall Study Full Analysis Set	646	645
Overall Study Safety Analysis Set	644	644
Overall Study COMPLETED	611	611
Overall Study NOT COMPLETED	35	34

Reasons for withdrawal

Reasons for withdrawal
Measure	IcoSema Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Overall Study Withdrawal by Subject	28	24
Overall Study Lost to Follow-up	4	7
Overall Study Death	2	3
Overall Study Site closure	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IcoSema n=646 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=645 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.	Total n=1291 Participants Total of all reporting groups
Age, Continuous	60.5 Years STANDARD_DEVIATION 10.5 • n=3 Participants	60.7 Years STANDARD_DEVIATION 10.2 • n=3 Participants	60.6 Years STANDARD_DEVIATION 10.3 • n=6 Participants
Sex: Female, Male Female	246 Participants n=3 Participants	246 Participants n=3 Participants	492 Participants n=6 Participants
Sex: Female, Male Male	400 Participants n=3 Participants	399 Participants n=3 Participants	799 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	101 Participants n=3 Participants	110 Participants n=3 Participants	211 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	545 Participants n=3 Participants	535 Participants n=3 Participants	1080 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 (NIH/OMB) American Indian or Alaska Native	5 Participants n=3 Participants	1 Participants n=3 Participants	6 Participants n=6 Participants
Race (NIH/OMB) Asian	216 Participants n=3 Participants	204 Participants n=3 Participants	420 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Black or African American	19 Participants n=3 Participants	25 Participants n=3 Participants	44 Participants n=6 Participants
Race (NIH/OMB) White	404 Participants n=3 Participants	410 Participants n=3 Participants	814 Participants n=6 Participants
Race (NIH/OMB) More than one race	2 Participants n=3 Participants	4 Participants n=3 Participants	6 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0), Week 52

Population: Full Analysis Set (FAS) included all randomised participants. Overall number of participants analyzed = participants with available data.

Outcome measures

Outcome measures
Measure	IcoSema n=598 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=605 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Change in Glycated Haemoglobin (HbA1c)	-1.60 Percentage point of HbA1c Standard Deviation 0.99	-0.90 Percentage point of HbA1c Standard Deviation 1.01

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 52

Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.

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.

Outcome measures

Outcome measures
Measure	IcoSema n=606 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=610 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Change in Body Weight	-3.71 Kilogram (Kg) Standard Deviation 4.87	1.96 Kilogram (Kg) Standard Deviation 4.76

SECONDARY outcome

Timeframe: From baseline week 0 to week 57

Population: Safety analysis set (SAS) included all randomised participants who are exposed to randomised treatment.

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.

Outcome measures

Outcome measures
Measure	IcoSema n=644 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=644 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
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)	91 Episodes	424 Episodes

SECONDARY outcome

Timeframe: From week 48 to week 52

Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.

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.

Outcome measures

Outcome measures
Measure	IcoSema n=481 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=488 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6	75.9 Percentage of time Standard Deviation 16.1	61.9 Percentage of time Standard Deviation 18.1

SECONDARY outcome

Timeframe: From week 48 to week 52

Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.

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.

Outcome measures

Outcome measures
Measure	IcoSema n=481 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=488 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6	0.27 Percentage of time Standard Deviation 0.55	0.33 Percentage of time Standard Deviation 0.82

SECONDARY outcome

Timeframe: From week 48 to week 52

Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.

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.

Outcome measures

Outcome measures
Measure	IcoSema n=481 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=488 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6	23.2 Percentage of time Standard Deviation 16.3	36.7 Percentage of time Standard Deviation 18.7

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 52

Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.

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.

Outcome measures

Outcome measures
Measure	IcoSema n=552 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=572 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Change in Fasting Plasma Glucose (FPG)	-1.90 Millimoles per litre (mmol/L) Standard Deviation 3.01	-1.65 Millimoles per litre (mmol/L) Standard Deviation 2.96

SECONDARY outcome

Timeframe: From week 50 to week 52

Population: SAS included all randomised participants who are exposed to randomised treatment. Overall number of participants analyzed = participants with available data.

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.

Outcome measures

Outcome measures
Measure	IcoSema n=575 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=596 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Weekly Basal Insulin Dose	170.6 Units of insulin Standard Deviation 83.3	366.5 Units of insulin Standard Deviation 225.5

SECONDARY outcome

Timeframe: From baseline week 0 to week 57

Population: SAS included all randomised participants who are exposed to randomised treatment.

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.

Outcome measures

Outcome measures
Measure	IcoSema n=644 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=644 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)	90 Episodes	419 Episodes

SECONDARY outcome

Timeframe: From baseline week 0 to week 57

Population: SAS included all randomised participants who are exposed to randomised treatment.

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.

Outcome measures

Outcome measures
Measure	IcoSema n=644 Participants Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.	Insulin Icodec n=644 Participants Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
Number of Severe Hypoglycaemic Episodes (Level 3)	1 Episodes	5 Episodes

Adverse Events

Icodec

Serious events: 69 serious events

Other events: 258 other events

Deaths: 3 deaths

IcoSema

Serious events: 59 serious events

Other events: 354 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Icodec n=644 participants at risk Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.	IcoSema n=644 participants at risk Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks.
Infections and infestations COVID-19	9.5% 61/644 • Number of events 62 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	10.4% 67/644 • Number of events 68 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Gastrointestinal disorders Constipation	1.2% 8/644 • Number of events 8 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	6.1% 39/644 • Number of events 55 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Metabolism and nutrition disorders Decreased appetite	0.16% 1/644 • Number of events 1 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	5.9% 38/644 • Number of events 48 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Eye disorders Diabetic retinopathy	5.4% 35/644 • Number of events 41 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	6.4% 41/644 • Number of events 46 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Gastrointestinal disorders Diarrhoea	7.1% 46/644 • Number of events 65 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	15.8% 102/644 • Number of events 187 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Nervous system disorders Dizziness	3.0% 19/644 • Number of events 27 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	5.7% 37/644 • Number of events 41 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Gastrointestinal disorders Dyspepsia	1.6% 10/644 • Number of events 11 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	6.8% 44/644 • Number of events 64 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Nervous system disorders Headache	3.1% 20/644 • Number of events 26 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	5.1% 33/644 • Number of events 58 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Infections and infestations Nasopharyngitis	7.9% 51/644 • Number of events 62 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	5.9% 38/644 • Number of events 50 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Gastrointestinal disorders Nausea	3.7% 24/644 • Number of events 29 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	23.8% 153/644 • Number of events 348 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Infections and infestations Upper respiratory tract infection	10.7% 69/644 • Number of events 84 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	8.4% 54/644 • Number of events 64 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.
Gastrointestinal disorders Vomiting	2.6% 17/644 • Number of events 19 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.	10.6% 68/644 • Number of events 118 • Week 0 to week 57 Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

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