Trial Outcomes & Findings for A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes (NCT NCT06340854)
NCT ID: NCT06340854
Last Updated: 2026-08-11
Results Overview
Change in HbA1c from week 0 to week 26 in percentage point is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
412 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2026-08-11
Participant Flow
The trial was conducted at 66 sites in 8 countries.
After screening, all participants entered the blinded run-in period. Participants remained on their pre-study basal insulin during the run-in period with continuous glucose monitoring (CGM). After the run-in period, participants were randomised (1:1) to receive once-weekly insulin icodec or once-daily insulin glargine.
Participant milestones
| Measure |
Insulin Icodec
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
206
|
|
Overall Study
Full Analysis Set
|
206
|
206
|
|
Overall Study
Safety Analysis Set
|
206
|
206
|
|
Overall Study
COMPLETED
|
206
|
203
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Insulin Icodec
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Icodec
n=206 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=206 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.41 Years
STANDARD_DEVIATION 9.91 • n=54 Participants
|
62.52 Years
STANDARD_DEVIATION 9.65 • n=54 Participants
|
62.47 Years
STANDARD_DEVIATION 9.77 • n=27 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=54 Participants
|
90 Participants
n=54 Participants
|
174 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=54 Participants
|
116 Participants
n=54 Participants
|
238 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=54 Participants
|
27 Participants
n=54 Participants
|
53 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
178 Participants
n=54 Participants
|
175 Participants
n=54 Participants
|
353 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
4 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
69 Participants
n=54 Participants
|
74 Participants
n=54 Participants
|
143 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=54 Participants
|
8 Participants
n=54 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
127 Participants
n=54 Participants
|
122 Participants
n=54 Participants
|
249 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native, White
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 26Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Change in HbA1c from week 0 to week 26 in percentage point is presented.
Outcome measures
| Measure |
Insulin Icodec
n=204 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=201 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Change in Glycated Haemoglobin (HbA1c)
|
-0.84 Percentage (%) point
Standard Deviation 0.83
|
-0.58 Percentage (%) point
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: week -4-0, week 22-26Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week -4-0 to week 22-26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements.
Outcome measures
| Measure |
Insulin Icodec
n=202 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=198 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Change in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL))
|
19.94 Percentage (%) of time
Standard Deviation 20.49
|
11.04 Percentage (%) of time
Standard Deviation 19.43
|
SECONDARY outcome
Timeframe: week 0 to week 26Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Change in DTSQs total treatment satisfaction from week 0 to week 26 is presented. DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contribute to 1 global score. Total Treatment Satisfaction score range is 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.
Outcome measures
| Measure |
Insulin Icodec
n=200 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=184 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction
|
3.94 Score on a scale
Standard Deviation 6.96
|
2.20 Score on a scale
Standard Deviation 5.94
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 31Population: Full analysis set included all randomised participants.
Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented.
Outcome measures
| Measure |
Insulin Icodec
n=206 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=206 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Number of Severe Hypoglycaemic Episodes (Level 3)
|
2 Episodes
|
1 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 31Population: Full analysis set included all randomised participants.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to week 31 is presented.
Outcome measures
| Measure |
Insulin Icodec
n=206 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=206 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)
|
53 Episodes
|
70 Episodes
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 31Population: Full analysis set included all randomised participants.
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) from baseline (week 0) to week 31 is presented.
Outcome measures
| Measure |
Insulin Icodec
n=206 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=206 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
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)
|
55 Episodes
|
71 Episodes
|
SECONDARY outcome
Timeframe: Week 22-26Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Time spent \< 3.0 mmol/L (54 mg/dL) during week 22 - 26 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below 3.0 mmol/L (54 mg/dL), divided by the total number of recorded measurements.
Outcome measures
| Measure |
Insulin Icodec
n=202 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=198 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Time Spent < 3.0 mmol/L (54 mg/dL)
|
0.27 % of time
Standard Deviation 0.48
|
0.23 % of time
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Week -4-0, Week 22-26Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Change in time spent \> 10.0 mmol/L 180 mg/dL from week -4 - 0 to week 22-26 is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above 10.0 mmol/L (180 mg/dL) divided by the total number of recorded measurements.
Outcome measures
| Measure |
Insulin Icodec
n=202 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=198 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Change in Time Spent > 10.0 mmol/L (180 mg/dL)
|
-20.54 % of time
Standard Deviation 21.10
|
-11.19 % of time
Standard Deviation 19.94
|
SECONDARY outcome
Timeframe: From week 24 to week 26Population: Safety analysis set included all randomised participants who are exposed to investigational intervention. Overall number of participants analyzed = Participants with available data for the outcome measure.
Mean weekly insulin dose from week 24 to week 26 is presented.
Outcome measures
| Measure |
Insulin Icodec
n=202 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=202 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Mean Weekly Insulin Dose
|
278.45 Units of insulin/week
Geometric Coefficient of Variation 71.44
|
270.19 Units of insulin/week
Geometric Coefficient of Variation 62.45
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: Safety analysis set included all randomised participants who are exposed to investigational intervention. Overall number of participants analyzed = Participants with available data for the outcome measure.
Change in body weight from baseline (week 0) to (week 26) is presented.
Outcome measures
| Measure |
Insulin Icodec
n=204 Participants
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=202 Participants
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Change in Body Weight
|
2.04 Kilogram (kg)
Standard Deviation 2.87
|
0.55 Kilogram (kg)
Standard Deviation 3.16
|
Adverse Events
Insulin Icodec
Serious events: 16 serious events
Other events: 42 other events
Deaths: 0 deaths
Insulin Glargine
Serious events: 12 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Icodec
n=206 participants at risk
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=206 participants at risk
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.97%
2/206 • Number of events 2 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Cardiac disorders
Angina unstable
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Cardiac disorders
Atrial flutter
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Infections and infestations
Bronchitis bacterial
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Investigations
Carcinoembryonic antigen increased
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Cardiac disorders
Coronary artery disease
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Immune system disorders
Hypersensitivity
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Vascular disorders
Hypertension
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Injury, poisoning and procedural complications
Lumbosacral plexus injury
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Ear and labyrinth disorders
Mixed deafness
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
General disorders
Oedema peripheral
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Nervous system disorders
Optic neuritis
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Infections and infestations
Otitis media acute
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
General disorders
Peripheral swelling
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Infections and infestations
Pneumonia
|
0.97%
2/206 • Number of events 2 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.97%
2/206 • Number of events 2 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Injury, poisoning and procedural complications
Subarachnoid haematoma
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Nervous system disorders
Syncope
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Infections and infestations
Wound infection
|
0.00%
0/206 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
0.49%
1/206 • Number of events 1 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
Other adverse events
| Measure |
Insulin Icodec
n=206 participants at risk
Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
Insulin Glargine
n=206 participants at risk
Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
|
|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
2.9%
6/206 • Number of events 10 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
7.3%
15/206 • Number of events 15 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
11/206 • Number of events 12 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
1.9%
4/206 • Number of events 4 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
28/206 • Number of events 35 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
7.8%
16/206 • Number of events 22 • From week 1 to week 31
Safety analysis set- all randomised participants who are exposed to investigational intervention. Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP.
|
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