Diabetes Mellitus, Type 2
Conditions
Brief summary
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin icodec. Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe. Participants will get IcoSema or insulin icodec, which participants must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 21 clinic visits, 31 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.
Interventions
DRUGIcoSema
Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
DRUGInsulin icodec
Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria 1. Male or female and age above or equal to 18 years at the time of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus 180 days or more before screening. 3. HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening. 4. Treated with once daily or twice daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20- 80 units/day for 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses for 90 days or more before screening: * Metformin * Sulfonylureas (a) * Meglitinides (glinides) (a) * DPP 4 inhibitors (a) * Sodium glucose co transporter 2 inhibitors * Alpha glucosidase inhibitors * Thiazolidinediones * Marketed oral combination products only including the products listed above. 5. Body mass index (BMI) below or equal to 40.0 kg/m\^2. (a) Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation. Key
Exclusion criteria
1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. 2. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids). 3. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. 4. Any episodes (as declared by the participant or in the medical records.) of diabetic ketoacidosis within 90 days before screening. 5. Presence or history of pancreatitis (acute or chronic) within 180 days before screening. 6. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. 7. Chronic heart failure classified as being in New York Heart Association Class IV at screening. 8. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. 9. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | Baseline (Week 0), Week 52 | Change from baseline (week 0) to week 52 in HbA1c is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3) | From baseline week 0 to week 57 | Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (\<) 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets. |
| Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | From week 48 to week 52 | Time in range was defined as 100 times the number of recorded measurements in glycemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above. |
| Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | From week 48 to week 52 | Time spent below threshold was defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above. |
| Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | From week 48 to week 52 | Time spent above threshold is defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above. |
| Change in Body Weight | Baseline (Week 0), Week 52 | Change from baseline (week 0) to week 52 in body weight is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above. |
| Weekly Basal Insulin Dose | From week 50 to week 52 | Estimated mean average weekly basal insulin dose from week 50 to week 52 of treatment is presented. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets. |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) | From baseline week 0 to week 57 | Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (\<) 3.0 mmol/L (54 mg/dL). The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets. |
| Number of Severe Hypoglycaemic Episodes (Level 3) | From baseline week 0 to week 57 | Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets. |
| Change in Fasting Plasma Glucose (FPG) | Baseline (Week 0), Week 52 | Change in FPG from baseline (week 0) to week 52 is presented. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above. |
Countries
Australia, Belgium, Bulgaria, China, Croatia, Finland, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, South Africa, South Korea, Taiwan, Turkey (Türkiye), United States
Participant flow
Recruitment details
The trial was conducted at 192 sites in 20 countries.
Pre-assignment details
Participants with type 2 diabetes (T2D) inadequately controlled with daily basal insulin were randomised in 1:1 ratio to receive subcutaneous (s.c.) injection of IcoSema or insulin icodec once weekly with or without oral anti-diabetic drugs (OADs).
Participants by arm
| Arm | Count |
|---|---|
| IcoSema Participants received once-weekly subcutaneous injections of 700 units per milliliter (U/mL) of insulin icodec and 2 milligrams per milliliter (mg/mL) of semaglutide for 52 weeks. | 646 |
| Insulin Icodec Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks. | 645 |
| Total | 1,291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 3 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Site closure | 1 | 0 |
| Overall Study | Withdrawal by Subject | 28 | 24 |
Baseline characteristics
| Characteristic | Insulin Icodec | Total | IcoSema |
|---|---|---|---|
| Age, Continuous | 60.7 Years STANDARD_DEVIATION 10.2 | 60.6 Years STANDARD_DEVIATION 10.3 | 60.5 Years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 110 Participants | 211 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 535 Participants | 1080 Participants | 545 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 204 Participants | 420 Participants | 216 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 44 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 410 Participants | 814 Participants | 404 Participants |
| Sex: Female, Male Female | 246 Participants | 492 Participants | 246 Participants |
| Sex: Female, Male Male | 399 Participants | 799 Participants | 400 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 645 | 2 / 646 |
| other Total, other adverse events | 258 / 644 | 354 / 644 |
| serious Total, serious adverse events | 69 / 644 | 59 / 644 |
Outcome results
Primary
Change in Glycated Haemoglobin (HbA1c)
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.
Time frame: Baseline (Week 0), Week 52
Population: Full Analysis Set (FAS) included all randomised participants. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IcoSema | Change in Glycated Haemoglobin (HbA1c) | -1.60 Percentage point of HbA1c | Standard Deviation 0.99 |
| Insulin Icodec | Change in Glycated Haemoglobin (HbA1c) | -0.90 Percentage point of HbA1c | Standard Deviation 1.01 |
p-value: <0.000195% CI: [-0.76, -0.57]ANCOVA
Secondary
Change in Body Weight
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.
Time frame: Baseline (Week 0), Week 52
Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IcoSema | Change in Body Weight | -3.71 Kilogram (Kg) | Standard Deviation 4.87 |
| Insulin Icodec | Change in Body Weight | 1.96 Kilogram (Kg) | Standard Deviation 4.76 |
Secondary
Change in Fasting Plasma Glucose (FPG)
Change in FPG from baseline (week 0) to week 52 is presented. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above.
Time frame: Baseline (Week 0), Week 52
Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IcoSema | Change in Fasting Plasma Glucose (FPG) | -1.90 Millimoles per litre (mmol/L) | Standard Deviation 3.01 |
| Insulin Icodec | Change in Fasting Plasma Glucose (FPG) | -1.65 Millimoles per litre (mmol/L) | Standard Deviation 2.96 |
Secondary
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)
Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (\<) 3.0 mmol/L (54 mg/dL). The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
Time frame: From baseline week 0 to week 57
Population: SAS included all randomised participants who are exposed to randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IcoSema | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) | 90 Episodes |
| Insulin Icodec | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) | 419 Episodes |
Secondary
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3)
Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (\<) 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit ; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
Time frame: From baseline week 0 to week 57
Population: Safety analysis set (SAS) included all randomised participants who are exposed to randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IcoSema | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3) | 91 Episodes |
| Insulin Icodec | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre [mmol/L] (54 Milligram Per Decilitre [mg/dL]), Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3) | 424 Episodes |
Secondary
Number of Severe Hypoglycaemic Episodes (Level 3)
Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit; 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
Time frame: From baseline week 0 to week 57
Population: SAS included all randomised participants who are exposed to randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IcoSema | Number of Severe Hypoglycaemic Episodes (Level 3) | 1 Episodes |
| Insulin Icodec | Number of Severe Hypoglycaemic Episodes (Level 3) | 5 Episodes |
Secondary
Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6
Time in range was defined as 100 times the number of recorded measurements in glycemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above.
Time frame: From week 48 to week 52
Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IcoSema | Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | 75.9 Percentage of time | Standard Deviation 16.1 |
| Insulin Icodec | Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | 61.9 Percentage of time | Standard Deviation 18.1 |
Secondary
Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6
Time spent above threshold is defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above.
Time frame: From week 48 to week 52
Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IcoSema | Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | 23.2 Percentage of time | Standard Deviation 16.3 |
| Insulin Icodec | Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | 36.7 Percentage of time | Standard Deviation 18.7 |
Secondary
Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6
Time spent below threshold was defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome measure was evaluated based on the data from in study period: Data from randomisation until last date of any of the following: 1) the last direct participant-site contact; 2) withdrawal for participants who withdraw their informed consent; 3) the last participant-investigator contact as defined by the investigator for participants who are lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death for participants who die before any of the above.
Time frame: From week 48 to week 52
Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IcoSema | Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | 0.27 Percentage of time | Standard Deviation 0.55 |
| Insulin Icodec | Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6 | 0.33 Percentage of time | Standard Deviation 0.82 |
Secondary
Weekly Basal Insulin Dose
Estimated mean average weekly basal insulin dose from week 50 to week 52 of treatment is presented. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1) last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.
Time frame: From week 50 to week 52
Population: SAS included all randomised participants who are exposed to randomised treatment. Overall number of participants analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IcoSema | Weekly Basal Insulin Dose | 170.6 Units of insulin | Standard Deviation 83.3 |
| Insulin Icodec | Weekly Basal Insulin Dose | 366.5 Units of insulin | Standard Deviation 225.5 |