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 Semaglutide (COMBINE 2) (NCT NCT05259033)

Last Updated: 2025-07-09

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

683 participants

Primary outcome timeframe

Baseline (week 0), (week 52)

Results posted on

2025-07-09

Participant Flow

The trial was conducted at 124 sites in 13 countries.

Participants were randomised in 1:1 ratio to receive subcutaneous (s.c.) injection of either IcoSema or semaglutide once weekly. The trial had a 52-week treatment period followed by a 5-week follow-up period.

Participant milestones

Participant milestones
Measure	IcoSema Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
Overall Study STARTED	342	341
Overall Study Full Analysis Set	342	341
Overall Study Safety Analysis Set	341	340
Overall Study Treated	341	340
Overall Study COMPLETED	329	336
Overall Study NOT COMPLETED	13	5

Reasons for withdrawal

Reasons for withdrawal
Measure	IcoSema Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
Overall Study Withdrawal by Subject	10	5
Overall Study Lost to Follow-up	1	0
Overall Study Death	2	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 Semaglutide (COMBINE 2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IcoSema n=342 Participants Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide n=341 Participants Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.	Total n=683 Participants Total of all reporting groups
Age, Continuous	59.9 Years STANDARD_DEVIATION 10.5 • n=5 Participants	58.3 Years STANDARD_DEVIATION 9.8 • n=7 Participants	59.1 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants	145 Participants n=7 Participants	286 Participants n=5 Participants
Sex: Female, Male Male	201 Participants n=5 Participants	196 Participants n=7 Participants	397 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	285 Participants n=5 Participants	289 Participants n=7 Participants	574 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	99 Participants n=5 Participants	90 Participants n=7 Participants	189 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	210 Participants n=5 Participants	224 Participants n=7 Participants	434 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), (week 52)

Population: Full Analysis Set (FAS) which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Outcome measures

Outcome measures
Measure	IcoSema n=325 Participants Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide n=335 Participants Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	-1.40 Percentage point of HbA1c Standard Deviation 0.91	-0.86 Percentage point of HbA1c Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline (week 0), (week 52)

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Change from baseline (week 0) to week 52 in FPG 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=313 Participants Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide n=317 Participants Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
Change From Baseline in Fasting Plasma Glucose (FPG)	-2.74 Millimoles per litre (mmol/L) Standard Deviation 2.85	-1.41 Millimoles per litre (mmol/L) Standard Deviation 2.89

SECONDARY outcome

Timeframe: Baseline (week 0), (week 52)

Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

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=325 Participants Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide n=336 Participants Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
Change From Baseline in Body Weight	0.89 Kilogram (kg) Standard Deviation 4.36	-3.77 Kilogram (kg) Standard Deviation 4.60

SECONDARY outcome

Timeframe: Week 0 to Week 57

Population: Safety Analysis Set (SAS) included all participants 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 (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=341 Participants Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide n=340 Participants Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) , Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3)	15 Episodes	13 Episodes

SECONDARY outcome

Timeframe: Week 0 to Week 57

Population: SAS included all participants 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 \< 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 (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=341 Participants Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide n=340 Participants Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)	15 Episodes	13 Episodes

SECONDARY outcome

Timeframe: Week 0 to Week 57

Population: SAS included all participants 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 (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=341 Participants Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide n=340 Participants Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
Number of Severe Hypoglycaemic Episodes (Level 3)	0 Episodes	0 Episodes

Adverse Events

IcoSema

Serious events: 38 serious events

Other events: 163 other events

Deaths: 2 deaths

Semaglutide

Serious events: 21 serious events

Other events: 159 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	IcoSema n=341 participants at risk Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	Semaglutide n=340 participants at risk Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams \[mg\], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
Infections and infestations COVID-19	15.0% 51/341 • Number of events 52 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	14.4% 49/340 • Number of events 53 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
Gastrointestinal disorders Constipation	3.2% 11/341 • Number of events 14 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	5.0% 17/340 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
Eye disorders Diabetic retinopathy	5.6% 19/341 • Number of events 20 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	2.9% 10/340 • Number of events 10 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
Gastrointestinal disorders Diarrhoea	11.1% 38/341 • Number of events 53 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	12.1% 41/340 • Number of events 82 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
Nervous system disorders Headache	5.9% 20/341 • Number of events 25 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	1.8% 6/340 • Number of events 6 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
Infections and infestations Nasopharyngitis	9.7% 33/341 • Number of events 45 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	9.7% 33/340 • Number of events 45 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
Gastrointestinal disorders Nausea	11.7% 40/341 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	11.5% 39/340 • Number of events 73 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
Infections and infestations Upper respiratory tract infection	6.5% 22/341 • Number of events 34 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	8.5% 29/340 • Number of events 34 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
Gastrointestinal disorders Vomiting	5.0% 17/341 • Number of events 24 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.	6.5% 22/340 • 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 (eCRF) until first date of any of the below:1) last follow up visit;2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms);3) end-date for in-study data points. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.

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