{"protocolSection":{"identificationModule":{"nctId":"NCT05352815","orgStudyIdInfo":{"id":"NN1535-4591"},"secondaryIdInfos":[{"id":"U1111-1260-8259","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2020-005281-34","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec","officialTitle":"A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.","acronym":"COMBINE 1"},"statusModule":{"statusVerifiedDate":"2025-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-06-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-03-19","type":"ACTUAL"},"completionDateStruct":{"date":"2024-04-23","type":"ACTUAL"},"studyFirstSubmitDate":"2022-04-24","studyFirstSubmitQcDate":"2022-04-24","studyFirstPostDateStruct":{"date":"2022-04-29","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-03-18","resultsFirstSubmitQcDate":"2025-03-18","resultsFirstPostDateStruct":{"date":"2025-04-03","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-11-27","lastUpdatePostDateStruct":{"date":"2025-12-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"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.\n\nThe study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin icodec.\n\nParticipants 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.\n\nParticipants 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.\n\nThe 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.\n\nWomen cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.\n\nNot 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."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1291,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"IcoSema","type":"EXPERIMENTAL","interventionNames":["Drug: IcoSema"]},{"label":"Insulin icodec","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Insulin icodec"]}],"interventions":[{"type":"DRUG","name":"IcoSema","description":"Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.","armGroupLabels":["IcoSema"]},{"type":"DRUG","name":"Insulin icodec","description":"Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.","armGroupLabels":["Insulin icodec"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Glycated Haemoglobin (HbA1c)","description":"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.","timeFrame":"Baseline (Week 0), Week 52"}],"secondaryOutcomes":[{"measure":"Change in Body Weight","description":"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.","timeFrame":"Baseline (Week 0), Week 52"},{"measure":"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)","description":"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.","timeFrame":"From baseline week 0 to week 57"},{"measure":"Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6","description":"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.","timeFrame":"From week 48 to week 52"},{"measure":"Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6","description":"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.","timeFrame":"From week 48 to week 52"},{"measure":"Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6","description":"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.","timeFrame":"From week 48 to week 52"},{"measure":"Change in Fasting Plasma Glucose (FPG)","description":"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.","timeFrame":"Baseline (Week 0), Week 52"},{"measure":"Weekly Basal Insulin Dose","description":"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.","timeFrame":"From week 50 to week 52"},{"measure":"Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)","description":"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.","timeFrame":"From baseline week 0 to week 57"},{"measure":"Number of Severe Hypoglycaemic Episodes (Level 3)","description":"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.","timeFrame":"From baseline week 0 to week 57"}]},"eligibilityModule":{"eligibilityCriteria":"Key inclusion criteria\n\n1. Male or female and age above or equal to 18 years at the time of signing informed consent.\n2. Diagnosed with type 2 diabetes mellitus 180 days or more before screening.\n3. HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.\n4. 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:\n\n   * Metformin\n   * Sulfonylureas (a)\n   * Meglitinides (glinides) (a)\n   * DPP 4 inhibitors (a)\n   * Sodium glucose co transporter 2 inhibitors\n   * Alpha glucosidase inhibitors\n   * Thiazolidinediones\n   * Marketed oral combination products only including the products listed above.\n5. 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.\n\nKey exclusion criteria\n\n1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.\n2. 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).\n3. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.\n4. Any episodes (as declared by the participant or in the medical records.) of diabetic ketoacidosis within 90 days before screening.\n5. Presence or history of pancreatitis (acute or chronic) within 180 days before screening.\n6. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.\n7. Chronic heart failure classified as being in New York Heart Association Class IV at screening.\n8. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.\n9. 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.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 2834)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pri Med Grp dba/Gil Ctr Fam","city":"Gilbert","state":"Arizona","zip":"85296","country":"United States","geoPoint":{"lat":33.35283,"lon":-111.78903}},{"facility":"Lenzmeier Fam Med CCT Research","city":"Glendale","state":"Arizona","zip":"85308","country":"United States","geoPoint":{"lat":33.53865,"lon":-112.18599}},{"facility":"Phoenician Centers for Research & Innovation PCRI","city":"Phoenix","state":"Arizona","zip":"85021","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Medical Investigations, Inc.","city":"Little Rock","state":"Arkansas","zip":"72211","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"John Muir Physicians Network","city":"Concord","state":"California","zip":"94520","country":"United States","geoPoint":{"lat":37.97798,"lon":-122.03107}},{"facility":"Headlands Research California, LLC","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Scripps Whittier Diabetes Inst","city":"La Jolla","state":"California","zip":"92037","country":"United States","geoPoint":{"lat":32.84727,"lon":-117.2742}},{"facility":"Clinical Trials Research_Sacramento","city":"Lincoln","state":"California","zip":"95648","country":"United States","geoPoint":{"lat":38.89156,"lon":-121.29301}},{"facility":"Torrance Clin Res Inst, Inc.","city":"Lomita","state":"California","zip":"90717","country":"United States","geoPoint":{"lat":33.79224,"lon":-118.31507}},{"facility":"Pacific Clinical Studies","city":"Los Alamitos","state":"California","zip":"90720","country":"United States","geoPoint":{"lat":33.80307,"lon":-118.07256}},{"facility":"Downtown LA Res Ctr. 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EClinicalMedicine. 2026 Jun 4;96:103985. doi: 10.1016/j.eclinm.2026.103985. eCollection 2026 Jun."},{"pmid":"40482671","type":"DERIVED","citation":"Mathieu C, Giorgino F, Kim SG, Larsen JH, Philis-Tsimikas A, Ramachandran A, Pagliaro Rocha TM, Shankarappa VB, Terauchi Y, Ji L. Once-weekly IcoSema versus once-weekly insulin icodec in type 2 diabetes management (COMBINE 1): an open-label, multicentre, treat-to-target, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):568-579. doi: 10.1016/S2213-8587(25)00096-8. Epub 2025 Jun 4."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"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).","recruitmentDetails":"The trial was conducted at 192 sites in 20 countries.","groups":[{"id":"FG000","title":"IcoSema","description":"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."},{"id":"FG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 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Missing HbA1c values at week 52 are imputed by using multiple imputation. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-0.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.76","ciUpperLimit":"-0.57"}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"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.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (Kg)","timeFrame":"Baseline (Week 0), Week 52","groups":[{"id":"OG000","title":"IcoSema","description":"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."},{"id":"OG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"606"},{"groupId":"OG001","value":"610"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.71","spread":"4.87"},{"groupId":"OG001","value":"1.96","spread":"4.76"}]}]}]},{"type":"SECONDARY","title":"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)","description":"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.","populationDescription":"Safety analysis set (SAS) included all randomised participants who are exposed to randomised treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From baseline week 0 to week 57","groups":[{"id":"OG000","title":"IcoSema","description":"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."},{"id":"OG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"644"},{"groupId":"OG001","value":"644"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"424"}]}]}]},{"type":"SECONDARY","title":"Percentage of Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6","description":"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.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of time","timeFrame":"From week 48 to week 52","groups":[{"id":"OG000","title":"IcoSema","description":"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."},{"id":"OG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"488"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"75.9","spread":"16.1"},{"groupId":"OG001","value":"61.9","spread":"18.1"}]}]}]},{"type":"SECONDARY","title":"Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6","description":"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.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of time","timeFrame":"From week 48 to week 52","groups":[{"id":"OG000","title":"IcoSema","description":"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."},{"id":"OG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"488"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.27","spread":"0.55"},{"groupId":"OG001","value":"0.33","spread":"0.82"}]}]}]},{"type":"SECONDARY","title":"Percentage of Time Spent > 10.0 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System, Dexcom G6","description":"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.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of time","timeFrame":"From week 48 to week 52","groups":[{"id":"OG000","title":"IcoSema","description":"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."},{"id":"OG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"481"},{"groupId":"OG001","value":"488"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.2","spread":"16.3"},{"groupId":"OG001","value":"36.7","spread":"18.7"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG)","description":"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.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per litre (mmol/L)","timeFrame":"Baseline (Week 0), Week 52","groups":[{"id":"OG000","title":"IcoSema","description":"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."},{"id":"OG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"552"},{"groupId":"OG001","value":"572"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.90","spread":"3.01"},{"groupId":"OG001","value":"-1.65","spread":"2.96"}]}]}]},{"type":"SECONDARY","title":"Weekly Basal Insulin Dose","description":"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.","populationDescription":"SAS included all randomised participants who are exposed to randomised treatment. Overall number of participants analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units of insulin","timeFrame":"From week 50 to week 52","groups":[{"id":"OG000","title":"IcoSema","description":"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."},{"id":"OG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"575"},{"groupId":"OG001","value":"596"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"170.6","spread":"83.3"},{"groupId":"OG001","value":"366.5","spread":"225.5"}]}]}]},{"type":"SECONDARY","title":"Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)","description":"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.","populationDescription":"SAS included all randomised participants who are exposed to randomised treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From baseline week 0 to week 57","groups":[{"id":"OG000","title":"IcoSema","description":"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."},{"id":"OG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"644"},{"groupId":"OG001","value":"644"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"419"}]}]}]},{"type":"SECONDARY","title":"Number of Severe Hypoglycaemic Episodes (Level 3)","description":"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.","populationDescription":"SAS included all randomised participants who are exposed to randomised treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From baseline week 0 to week 57","groups":[{"id":"OG000","title":"IcoSema","description":"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."},{"id":"OG001","title":"Insulin Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"644"},{"groupId":"OG001","value":"644"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"5"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Week 0 to week 57","description":"Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form until first date of any of the below: last follow up visit; last date on random-ised treatment +6 weeks (corresponding to 5 weeks after end of dosing interval for both arms); end-date for in-study data points. AEs were evaluated using SAS. All-Cause Mortality was assessed for all participants enrolled in study.","eventGroups":[{"id":"EG000","title":"Icodec","description":"Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.","deathsNumAffected":3,"deathsNumAtRisk":645,"seriousNumAffected":69,"seriousNumAtRisk":644,"otherNumAffected":258,"otherNumAtRisk":644},{"id":"EG001","title":"IcoSema","description":"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.","deathsNumAffected":2,"deathsNumAtRisk":646,"seriousNumAffected":59,"seriousNumAtRisk":644,"otherNumAffected":354,"otherNumAtRisk":644}],"seriousEvents":[{"term":"Abdominal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":644},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":644}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":2,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":644},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":644}]},{"term":"Bladder neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 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26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Calculus urinary","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":644},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":644}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":644},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":644}]},{"term":"Cardiac failure acute","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Cardio-respiratory arrest","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":644},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":644}]},{"term":"Carotid artery stenosis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Cartilage injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":644},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":644}]},{"term":"Cerebral infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":644},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":644}]},{"term":"Chest discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":644},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":644}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Chronic obstructive pulmonary disease","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Clavicle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Coronary artery stenosis","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Cystocele","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":644},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":644}]},{"term":"Deafness unilateral","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Death","organSystem":"General disorders","sourceVocabulary":"MedDRA 26","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":644},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":644}]},{"term":"Degenerative aortic valve disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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