Trial Outcomes & Findings for A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes (NCT NCT05813912)
NCT ID: NCT05813912
Last Updated: 2026-06-03
Results Overview
Change in HbA1c (percentage) from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.
COMPLETED
PHASE3
148 participants
Baseline (Week 26), Week 52
2026-06-03
Participant Flow
The trial was conducted in 5 countries as follows: Poland, Serbia, Czechia, Malaysia and Thailand.
The trial included a 26-week run-in period during which all participants were switched from their previous basal insulin regimen to insulin icodec. This was followed by a 26-week treatment phase with insulin icodec combined with semaglutide.
Participant milestones
| Measure |
Insulin Icodec + Semaglutide
Participants received once-weekly insulin icodec during a 26-week run-in period to allow dose optimization. Participants who met the intensification criteria then entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 milligrams (mg) and titrated up to 1.0 mg, concomitant with insulin icodec at 700 units per milliliter (U/mL).
|
|---|---|
|
Run-in Period (Week 0 to Week 26)
STARTED
|
148
|
|
Run-in Period (Week 0 to Week 26)
Exposed
|
148
|
|
Run-in Period (Week 0 to Week 26)
Safety Analysis Set (SAS)
|
148
|
|
Run-in Period (Week 0 to Week 26)
COMPLETED
|
94
|
|
Run-in Period (Week 0 to Week 26)
NOT COMPLETED
|
54
|
|
Treatment Period (Week 26 to Week 52)
STARTED
|
94
|
|
Treatment Period (Week 26 to Week 52)
Exposed
|
94
|
|
Treatment Period (Week 26 to Week 52)
Full Analysis Set (FAS)
|
94
|
|
Treatment Period (Week 26 to Week 52)
COMPLETED
|
91
|
|
Treatment Period (Week 26 to Week 52)
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Insulin Icodec + Semaglutide
Participants received once-weekly insulin icodec during a 26-week run-in period to allow dose optimization. Participants who met the intensification criteria then entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 milligrams (mg) and titrated up to 1.0 mg, concomitant with insulin icodec at 700 units per milliliter (U/mL).
|
|---|---|
|
Run-in Period (Week 0 to Week 26)
Failing to meet intensification requirements
|
51
|
|
Run-in Period (Week 0 to Week 26)
Withdrawal by Subject
|
1
|
|
Run-in Period (Week 0 to Week 26)
Physician Decision
|
1
|
|
Run-in Period (Week 0 to Week 26)
Death
|
1
|
|
Treatment Period (Week 26 to Week 52)
Failing to meet intensification requirements
|
1
|
|
Treatment Period (Week 26 to Week 52)
Withdrawal by Subject
|
1
|
|
Treatment Period (Week 26 to Week 52)
Lost to Follow-up
|
1
|
Baseline Characteristics
A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Icodec + Semaglutide
n=148 Participants
Participants received once-weekly insulin icodec during a 26-week run-in period to allow dose optimization. Participants who met the intensification criteria then entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Age, Continuous
|
60.11 Years
STANDARD_DEVIATION 9.75 • n=20 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 26), Week 52Population: Full analysis set (FAS) included all participants allocated to the intensification phase. Overall number of participants analyzed = participants with available data.
Change in HbA1c (percentage) from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.
Outcome measures
| Measure |
Insulin Icodec + Semaglutide
n=91 Participants
Participants who met the intensification criteria in run-in Period entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Change in Glycated Haemoglobin (HbA1c)
|
-1.23 Percentage (%) of HbA1c
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Baseline (Week 26), Week 52Population: FAS included all participants allocated to the intensification phase. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in mean 7-point SMPG profiles from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.
Outcome measures
| Measure |
Insulin Icodec + Semaglutide
n=82 Participants
Participants who met the intensification criteria in run-in Period entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles
|
-1.69 millimoles per liter (mmol/L)
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Baseline (Week 26), Week 52Population: FAS included all participants allocated to the intensification phase. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in mean post-prandial glucose increment from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.
Outcome measures
| Measure |
Insulin Icodec + Semaglutide
n=71 Participants
Participants who met the intensification criteria in run-in Period entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Change in Mean Post-prandial Glucose Increment (Over All Meals)
|
-1.27 mmol/L
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Baseline (Week 26), Week 52Population: FAS included all participants allocated to the intensification phase. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in FPG from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.
Outcome measures
| Measure |
Insulin Icodec + Semaglutide
n=90 Participants
Participants who met the intensification criteria in run-in Period entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-1.29 mmol/L
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: From baseline (week 26) to week 57Population: SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure.
Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).
Outcome measures
| Measure |
Insulin Icodec + Semaglutide
n=94 Participants
Participants who met the intensification criteria in run-in Period entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Number of Severe Hypoglycaemic Episodes (Level 3)
|
0 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 26) to week 57Population: SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).
Outcome measures
| Measure |
Insulin Icodec + Semaglutide
n=94 Participants
Participants who met the intensification criteria in run-in Period entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 Milligrams Per Deciliter {mg/dL}], Confirmed by Blood Glucose [BG] Meter)
|
13 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 26) to week 57Population: SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).
Outcome measures
| Measure |
Insulin Icodec + Semaglutide
n=94 Participants
Participants who met the intensification criteria in run-in Period entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L [54 mg/dL]), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
|
13 Episodes
|
SECONDARY outcome
Timeframe: Baseline (Week 26), Week 52Population: SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure.
Change in body weight from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).
Outcome measures
| Measure |
Insulin Icodec + Semaglutide
n=92 Participants
Participants who met the intensification criteria in run-in Period entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Change in Body Weight
|
-3.85 Kilograms (Kg)
Standard Deviation 3.98
|
SECONDARY outcome
Timeframe: From week 25 to week 52Population: SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure.
Relative change in weekly insulin icodec dose from week 25 to week 52 is presented.
Outcome measures
| Measure |
Insulin Icodec + Semaglutide
n=49 Participants
Participants who met the intensification criteria in run-in Period entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|
|
Relative Change in Weekly Insulin Icodec Dose
|
0.76 Insulin Units per Week
Interval 0.72 to 0.81
|
Adverse Events
Icodec: Run-in Period
Insulin Icodec + Semaglutide: Treatment Period
Serious adverse events
| Measure |
Icodec: Run-in Period
n=148 participants at risk
Participants received once-weekly insulin icodec during a 26-week run-in period to allow dose optimization.
|
Insulin Icodec + Semaglutide: Treatment Period
n=94 participants at risk
Participants who met the intensification criteria then entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/148 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
1.1%
1/94 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/148 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
1.1%
1/94 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/148 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
1.1%
1/94 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/148 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
1.1%
1/94 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Cardiac disorders
Angina Pectoris
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Infections and infestations
Gangrene
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Investigations
Anticoagulation Drug Level Increased
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Nervous system disorders
Basal Ganglia Haemorrhage
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Nervous system disorders
Lacunar Infarction
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Psychiatric disorders
Alcohol Abuse
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Vascular disorders
Hypertensive Urgency
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.68%
1/148 • Number of events 1 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
Other adverse events
| Measure |
Icodec: Run-in Period
n=148 participants at risk
Participants received once-weekly insulin icodec during a 26-week run-in period to allow dose optimization.
|
Insulin Icodec + Semaglutide: Treatment Period
n=94 participants at risk
Participants who met the intensification criteria then entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/148 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
6.4%
6/94 • Number of events 10 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/148 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
8.5%
8/94 • Number of events 20 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Eye disorders
Diabetic Retinopathy
|
5.4%
8/148 • Number of events 8 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
0.00%
0/94 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/148 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
5.3%
5/94 • Number of events 5 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/148 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
19.1%
18/94 • Number of events 25 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
6/148 • Number of events 8 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
7.4%
7/94 • Number of events 11 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/148 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
6.4%
6/94 • Number of events 6 • Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
|
Additional Information
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