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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1260-8259 | Other Identifier | World Health Organization (WHO) | |
| 2020-005281-34 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IcoSema | Experimental |
| |
| Insulin icodec | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IcoSema | Drug | Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0), Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key inclusion criteria
Male or female and age above or equal to 18 years at the time of signing informed consent.
Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pri Med Grp dba/Gil Ctr Fam | Gilbert | Arizona | 85296 | United States | ||
| Lenzmeier Fam Med CCT Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42306490 | Derived | De Block C, Benamar M, Fu A, Maltesen R, Giorgino F. CGM-derived postprandial glucose with IcoSema versus other insulin regimens: a post hoc analysis of COMBINE 1 and 3. EClinicalMedicine. 2026 Jun 4;96:103985. doi: 10.1016/j.eclinm.2026.103985. eCollection 2026 Jun. | |
| 40482671 | Derived | 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. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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).
The trial was conducted at 192 sites in 20 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Insulin Icodec |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2023 | Mar 18, 2025 |
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| Insulin icodec | Drug | Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks. |
|
| Baseline (Week 0), Week 52 |
| 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. | From baseline week 0 to week 57 |
| 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. | From week 48 to week 52 |
| 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. | From week 48 to week 52 |
| 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. | From week 48 to week 52 |
| 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. | Baseline (Week 0), Week 52 |
| 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. | From week 50 to week 52 |
| 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. | From baseline week 0 to week 57 |
| 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. | From baseline week 0 to week 57 |
| Glendale |
| Arizona |
| 85308 |
| United States |
| Phoenician Centers for Research & Innovation PCRI | Phoenix | Arizona | 85021 | United States |
| Medical Investigations, Inc. | Little Rock | Arkansas | 72211 | United States |
| John Muir Physicians Network | Concord | California | 94520 | United States |
| Headlands Research California, LLC | Escondido | California | 92025 | United States |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | United States |
| Clinical Trials Research_Sacramento | Lincoln | California | 95648 | United States |
| Torrance Clin Res Inst, Inc. | Lomita | California | 90717 | United States |
| Pacific Clinical Studies | Los Alamitos | California | 90720 | United States |
| Downtown LA Res Ctr. Inc. | Los Angeles | California | 90017 | United States |
| Velocity Clin Res Los Angeles | Los Angeles | California | 90017 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Clinical Trials Research_Sacramento_0 | Sacramento | California | 95821 | United States |
| San Diego Family Care | San Diego | California | 92111 | United States |
| NorCal Endocrinology and Internal Medicine | San Ramon | California | 94583 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Creekside Endocrine Associates, PC | Denver | Colorado | 80246 | United States |
| Clinical Res Of W Florida Inc | Clearwater | Florida | 33765 | United States |
| Northeast Research Institute | Fleming Island | Florida | 32003 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Adult Medicine of Lake County, Inc. | Mt. Dora | Florida | 32757 | United States |
| Suncoast Clin Res Port Richey | New Port Richey | Florida | 34652 | United States |
| Clinical Neuroscience Solution | Orlando | Florida | 32801 | United States |
| Florida Inst For Clin Res | Orlando | Florida | 32825 | United States |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | United States |
| Javara/Privia Med Grp GA,LLC | Albany | Georgia | 31707 | United States |
| Emory University SOM | Atlanta | Georgia | 30303 | United States |
| Javara Inc. | Fayetteville | Georgia | 30214 | United States |
| Physicians Research Assoc. LLC | Lawrenceville | Georgia | 30046 | United States |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | United States |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | United States |
| Saltzer Medical Group Research | Nampa | Idaho | 83686-6011 | United States |
| UnityPoint Health-Diabetes Care Center | Peoria | Illinois | 61603 | United States |
| Endeavor Health | Skokie | Illinois | 60077 | United States |
| Iowa Diab & Endo Res Center | West Des Moines | Iowa | 50266 | United States |
| Cotton O'Neil Diab & Endo Ctr | Topeka | Kansas | 66606 | United States |
| The Research Group of Lexington LLC | Lexington | Kentucky | 40503 | United States |
| Barnum Medical Research Inc. | Natchitoches | Louisiana | 71457 | United States |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | United States |
| Ileana J Tandron APMC | Slidell | Louisiana | 70461-4231 | United States |
| MedStar Hlth Res Institute | Hyattsville | Maryland | 20782 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115-5804 | United States |
| MassResearch, LLC | Waltham | Massachusetts | 02453 | United States |
| Northern Pines Hlth Ctr, PC | Buckley | Michigan | 49620 | United States |
| Elite Research Center | Flint | Michigan | 48532 | United States |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 63303 | United States |
| Jefferson City Medical Group, PC | Jefferson City | Missouri | 65109 | United States |
| Methodist Phys. Clinic | Omaha | Nebraska | 68114 | United States |
| University of NE Med Ctr | Omaha | Nebraska | 68198 | United States |
| University of Nevada School of Medicine | Las Vegas | Nevada | 89102 | United States |
| Palm Research Center Inc. | Las Vegas | Nevada | 89148 | United States |
| Southern New Hampshire Diabete | Nashua | New Hampshire | 03060 | United States |
| John J Shelmet, MD | Lawrenceville | New Jersey | 08648 | United States |
| Albuquerque Clin Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Mid Hudson Medical Research, PLLC | New Windsor | New York | 12553 | United States |
| DiGiovanna Institute for Medical Education & Research | North Massapequa | New York | 11758-1802 | United States |
| Endocrine Associates of Long Island, PC | Smithtown | New York | 11787 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | United States |
| Javara Inc. / Tryon Medical Partners PLLC | Charlotte | North Carolina | 28287 | United States |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | United States |
| Central Ohio Clinical Research LLC | Columbus | Ohio | 43213 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| New Venture Medical Research | Wadsworth | Ohio | 44281 | United States |
| Intend Research | Norman | Oklahoma | 73069 | United States |
| Care Access | Warwick | Rhode Island | 02886 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| Athens Medical Group | Athens | Tennessee | 37303 | United States |
| AM Diabetes And Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| Holston Medical Group_Bristol | Bristol | Tennessee | 37620 | United States |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | United States |
| Univ Diab & Endo Consultants | Chattanooga | Tennessee | 37411 | United States |
| HealthStar Physicians PC | Morristown | Tennessee | 37813 | United States |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | United States |
| Texas Diabetes & Endocrinology, P.A._Austin | Austin | Texas | 78731 | United States |
| Texas Diabetes & Endocrinology, P.A._Austin | Austin | Texas | 78749 | United States |
| Osvaldo A. Brusco MD PA | Corpus Christi | Texas | 78414 | United States |
| Cedar Research | Dallas | Texas | 75038 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| Univ of TX SW Med Ctr Dallas | Dallas | Texas | 75390-9302 | United States |
| Diabetes and Thyroid Ctr of FW | Fort Worth | Texas | 76132 | United States |
| PrimeCare Medical Group | Houston | Texas | 77024 | United States |
| Javara Inc. / Privia Medical Group Gulf Coast PLLC | Houston | Texas | 77054 | United States |
| PlanIt Research, PLLC | Houston | Texas | 77079 | United States |
| Protenium Clinical Research | Hurst | Texas | 76054 | United States |
| Medical Colleagues-Texas LLP | Katy | Texas | 77450 | United States |
| Andres Garcia-Zuniga, MD, P.A | Laredo | Texas | 78041 | United States |
| Milton Haber, M.D. | Laredo | Texas | 78041 | United States |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | United States |
| Clinical Investigations Of Texas | Plano | Texas | 75075 | United States |
| Texas Diabetes &Endocrinology | Round Rock | Texas | 78681 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Briggs Clinical Research, LLC | San Antonio | Texas | 78224 | United States |
| Audie L. Murphy VA Hospital | San Antonio | Texas | 78229 | United States |
| Diabetes & Gladular Disease Research A Cetero Research Co | San Antonio | Texas | 78229 | United States |
| Diabetes Glandular Diseases Clinic | San Antonio | Texas | 78229 | United States |
| Javara Inc Privia Grp Gulf Cst | San Marcos | Texas | 78666 | United States |
| SimCare, PLLC | Sugar Land | Texas | 77478 | United States |
| Sugar Lakes Family Practice PA | Sugar Land | Texas | 77479 | United States |
| Hillcrest Family Health Center | Waco | Texas | 76708 | United States |
| Javara Inc. / Privia Medical Group LLC_Appomattox | Appomattox | Virginia | 24522 | United States |
| Javara Inc/Privia Md GpLLC Fst | Forest | Virginia | 24551 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23510 | United States |
| Amherst Family Practice P.C. | Winchester | Virginia | 22601 | United States |
| Sound Medical Research | Port Orchard | Washington | 98366 | United States |
| Rainier Clin Res Ctr Inc | Renton | Washington | 98057 | United States |
| Ascension Columbia St. Mary's Hospital | Milwaukee | Wisconsin | 53211 | United States |
| The Canberra Hospital_Garran | Garran | Australian Capital Territory | 2605 | Australia |
| Holdsworth House Clinical Research | Darlinghurst | New South Wales | 2010 | Australia |
| Momentum Clinical Research Darlinghurst | Darlinghurst | New South Wales | 2010 | Australia |
| Novatrials | Kotara | New South Wales | 2289 | Australia |
| Illawarra Diabetes Service Clinical Trials & Research Unit | Wollongong | New South Wales | 2500 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Southern Adelaide Diabetes & Endocrine Services | Oaklands Park | South Australia | 5046 | Australia |
| Launceston General Hospital | Launceston | Tasmania | 7250 | Australia |
| Barwon Health (The Geelong Hospital) | Geelong | Victoria | 3220 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Imeldaziekenhuis - Bonheiden - Department of Endocrinology | Bonheiden | 2820 | Belgium |
| UZ Brussel - Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
| Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie | Brussels | 1200 | Belgium |
| UZA - UZ Antwerpen - Department of Endocrinology | Edegem | 2650 | Belgium |
| AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie | Kortrijk | 8500 | Belgium |
| CHU Tivoli | La Louvière | 7100 | Belgium |
| UZ Leuven - Endocrinology | Leuven | 3000 | Belgium |
| IPSMC - Dr. Nikolay Kostadinov EOOD | Burgas | 8000 | Bulgaria |
| Medical center Medi City 21 OOD | Kyustendil | 2500 | Bulgaria |
| DCC I- Pleven EOOD Endocrinology | Pleven | 5801 | Bulgaria |
| UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic | Plovdiv | 4001 | Bulgaria |
| MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases | Sofia | 1606 | Bulgaria |
| Anhui Provincial Hospital-Endocrinology | Hefei | Anhui | 230001 | China |
| Peking University People's Hospital-Endocrinology | Beijing | Beijing Municipality | 100044 | China |
| Chongqing University Three Gorges Hospital | Chongqing | Chongqing Municipality | 404000 | China |
| Huizhou Central People's Hospital-Endocrinology | Huizhou | Guangdong | 516001 | China |
| Harrison International Peace Hospital | Hengshui | Hebei | 053000 | China |
| Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology | Hengshui | Hebei | 053000 | China |
| Huaihe Hospital of Henan University-Endocrinology | Kaifeng | Henan | 475000 | China |
| Changzhou No.2 People's Hospital, Yanghu Branch | Changzhou | Jiangsu | 213003 | China |
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | 213004 | China |
| The Second Affiliated Hospital of Nanjing Medical University-Endocrinology | Nanjing | Jiangsu | 210011 | China |
| The Second Affiliated Hospital of Nanjing Medical University_Nanjing | Nanjing | Jiangsu | 210011 | China |
| The Second Affiliated Hospital of Soochow University-Endocrinology | Suzhou | Jiangsu | 215004 | China |
| The Affiliated Hospital of Jiangsu University-Endocrinology | Zhenjiang | Jiangsu | 212001 | China |
| Jinan Central Hospital Affiliated to Shandong University | Jinan | Shandong | 250013 | China |
| Shanghai Fifth People's Hospital-Endocrinology | Shanghai | Shanghai Municipality | 200240 | China |
| General Hospital of Tianjin Medical University-Endocrinology | Tianjin | Tianjin Municipality | 300052 | China |
| The Second Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | 300211 | China |
| Poliklinika Solmed | Zagreb | City of Zagreb | 10000 | Croatia |
| Poliklinika SLAVONIJA OSIJEK | Osijek | County of Osijek-Baranja | 31000 | Croatia |
| Klinicki bolnicki centar Osijek | Osijek | 31 000 | Croatia |
| Opca bolnica Pula | Pula | 52100 | Croatia |
| KBC Rijeka, Endokrinologija | Rijeka | 51000 | Croatia |
| Ähtärin terveysasema | Ähtäri | 63700 | Finland |
| Health Step Finland Oy | Kuopio | 70210 | Finland |
| Etelä-Savon sosiaali- ja terveyspalvelujen kuntayhtymä | Mikkeli | 50100 | Finland |
| Raision sosiaali- ja terveyskeskus | Raisio | 21200 | Finland |
| Tampereen diabetesvastaanotto | Tampere | 33900 | Finland |
| Turku University Hospital | Turku | 20520 | Finland |
| Yashoda Hospital | Secunderabad | Andhra Pradesh | 500003 | India |
| Apollo Excelcare Hospital | Guwahati | Assam | 781033 | India |
| Gujarat Endocrine Centre | Ahmedabad | Gujarat | 380052 | India |
| Nirmal Hospital Pvt. Ltd. | Surat | Gujarat | 395002 | India |
| Lifecare Hospital and Research Centre | Bangalore | Karnataka | 560092 | India |
| Mysore Medical College and Research Institute | Mysore | Karnataka | 570001 | India |
| Government Medical College, Kozhikode | Kozhikode | Kerala | 673008 | India |
| Jothydev's Diabetes & Research Center | Thriruvananthapuram | Kerala | 695 032 | India |
| TOTALL Diabetes Hormone Institute | Indore | Madhya Pradesh | 452010 | India |
| Excel Endocrine Centre | Kolhāpur | Maharashtra | 416008 | India |
| BYL Nair Hospital and T N Medical College Department of endo | Mumbai | Maharashtra | 400008 | India |
| Seth GS medical college and KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| Bhaktivedanta Hospital & Research Institute | Mumbai | Maharashtra | 401107 | India |
| Inamdar Multispeciality Hospital | Pune | Maharashtra | 411040 | India |
| S.C.B. Medical College | Cuttack | Odisha | 753007 | India |
| Post Graduate Institute of Medical Education & Research | Chandigarh | Punjab | 160012 | India |
| Dayanand Medical College & Hospital_Ludhiana | Ludhiana | Punjab | 141001 | India |
| M.V.Hospital for Diabetes Pvt. Ltd. | Chennai | Tamil Nadu | 600 013 | India |
| Arthur Asirvatham hospital, | Madurai | Tamil Nadu | 625020 | India |
| Osmania General Hospital | Hyderabad | Telangana | 500012 | India |
| Ramdev Rao Hospital | Hyderabad | Telangana | 500072 | India |
| Lady Hardinge Medical College | New Delhi | 110001 | India |
| Sir Ganga Ram Hospital | New Delhi | 110060 | India |
| A.O.U. Consorziale Policlinico di Bari | Bari | BA | 70124 | Italy |
| Pol. Uni. Campus Biomedico | Roma | RM | 00128 | Italy |
| Policlinico Mater Domini Università di Catanzaro | Catanzaro | 88100 | Italy |
| ASL 4 Chiavarese | Chiavari (genova) | 16043 | Italy |
| Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Seino Internal Medicine Clinic_Internal medicine | Koriyama-shi | Fukushima, Japan | 963-8851 | Japan |
| Manda Memorial Hospital_Internal Medicine | Sapporo-shi, Hokkaido | Hokkaido, Japan | 060-0062 | Japan |
| Hayashi Diabetes Clinic | Chigasaki-shi, Kanagawa | Kanagawa, Japan | 253-0044 | Japan |
| Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine | Chigasaki-shi | Kanagawa, Japan | 253-0044 | Japan |
| Jinnouchi Hospital_Internal Medicine | Kumamoto | Kumamoto, Japan | 862-0976 | Japan |
| Heiwadai Hospital_Internal Medicine | Miyazaki | Miyazaki | 880-0034 | Japan |
| Heiwadai Hospital | Miyazaki | Miyazaki | 880-0034 | Japan |
| Kumanomae Nishimura Naika Clinic_Internal Medicine | Arakawa-ku, Tokyo | 116-0012 | Japan |
| Akaicho Clinic | Chiba-shi, Chiba | 260-0804 | Japan |
| Futata Tetsuhiro Clinic Meinohama_Internal medicine | Fukuoka-shi, Fukuoka | 819-0006 | Japan |
| Futata Tetsuhiro Clinic Meinohama | Fukuoka-shi, Fukuoka | 819-0006 | Japan |
| Kunisaki Makoto Clinic | Fukuoka-shi, Fukuoka | 819-0168 | Japan |
| Sasaki Internal Medicine | Hokkaido | 062-0007 | Japan |
| Yoshimura clinic | Kumamoto | 861-8039 | Japan |
| Hisatomi Clinic | Saga-shi, Saga | 840-0937 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Tokyo | 103-0027 | Japan |
| Fukuwa Clinic_Internal Medicine | Tokyo | 104-0031 | Japan |
| Yokohama City University Hospital, Endocrinology, Metabolism | Yokohama-shi, Kanagawa | 236-0004 | Japan |
| Hospital Universitario Dr. José Eleuterio González_Monterrey | Monterrey | Nuevo León | 64460 | Mexico |
| Centro de Investigación Cardiometabólica de Aguascalientes | Aguascalientes | 20230 | Mexico |
| Clínicos Asociados BOCM, S.C. | Mexico City | 03300 | Mexico |
| Nordlandssykehuset Bodø | Bodø | 8005 | Norway |
| Drammen sykehus - Vestre Viken HF | Drammen | 3004 | Norway |
| Bærum sykehus | Gjettum | 1346 | Norway |
| Sykehuset Innlandet HF Hamar | Hamar | 2318 | Norway |
| Akershus universitetssykehus HF | Lørenskog | 1478 | Norway |
| Oslo universitetssykehus Aker | Oslo | 0586 | Norway |
| St. Olavs Hospital HF | Trondheim | NO-7030 | Norway |
| NZOZ Przychodnia Specjalistyczna Medica | Lublin | Lubelski | 20-538 | Poland |
| Uniwersyteckie Centrum Kliniczne (UCK) | Gdansk | 80-214 | Poland |
| NZOZ "CenterMed Lublin" Sp. z o.o. | Lublin | 20-044 | Poland |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji | Warsaw | 02-507 | Poland |
| Unidade Local De Saude De Matosinhos E.P.E. | Senhora Da Hora, Matosinhos | Matosinhos | 4464-513 | Portugal |
| Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta | Almada | 2805-267 | Portugal |
| Unidade Local De Saude De Amadora Sintra E.P.E. - Hospital Prof. Dr. Fernando da Fonseca | Amadora | 2720-276 | Portugal |
| Unidade Local De Saude Da Regiao De Aveiro E.P.E. | Aveiro | 3814-501 | Portugal |
| Unidade de Local de Saúde de Braga | Braga | 4710-243 | Portugal |
| APDP - Associação Protectora dos Diabéticos de Portugal | Lisbon | 1250-189 | Portugal |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| Hospital Da Luz S.A. | Lisbon | 1500-650 | Portugal |
| Unidade Local de Saúde de Matosinhos | Matosinhos Municipality | 4464-513 | Portugal |
| Unidade Local de Saúde de Santo António, E.P.E | Porto | 4099-001 | Portugal |
| Hospital Luz Arrabida, S.A. | Vila Nova de Gaia | 4400-346 | Portugal |
| Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E. | Vila Real | 5000-508 | Portugal |
| Advanced Clinical Research LLC | Bayamón | 00959 | Puerto Rico |
| Manati Ctr For Clin Research | Manati | 00674 | Puerto Rico |
| Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila | Bucharest | Bucurestii | 020475 | Romania |
| CMI Diabet, Nutritie, Boli Metabolice "Dr Pop Lavinia" | Baia Mare | Maramureş | 430222 | Romania |
| Mariodiab Clinic SRL | Brasov | 500101 | Romania |
| SC Consultmed SRL | Iași | 700547 | Romania |
| Clinica Korall S.R.L. Satu Mare | Satu Mare | 440055 | Romania |
| Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava | Suceava | 720237 | Romania |
| Tumen State Medical University | Tyumen | Russia | 625023 | Russia |
| Arkhangelsk Regional Clinical Hospital | Arkhangelsk | 163045 | Russia |
| Irkutsk State Medical Academy of Postgraduate Education | Irkutsk | 664049 | Russia |
| Limited Liability Company "AriVa-Med" | Kursk | 305016 | Russia |
| City Consultative & Diagnostic Centre #1 | Saint Petersburg | 194354 | Russia |
| Saratov regional clinical hospital | Saratov | 410053 | Russia |
| Sverdlovsk Regional Clinical Hospital #1 | Yekaterinburg | 620102 | Russia |
| Endocrinology, Diabetes and Metabolism Diseases Clinic | Belgrade | 11000 | Serbia |
| Deepak Lakha | Johannesburg | Gauteng | 1820 | South Africa |
| Hemant Makan | Johannesburg | Gauteng | 1827 | South Africa |
| Wits Bara Clinical Trial Site | Johannesburg | Gauteng | 2013 | South Africa |
| Dr Pillay's Rooms | Durban | KwaZulu-Natal | 4450 | South Africa |
| Armansis Medical Centre | Brits | North West | 0250 | South Africa |
| Langeberg Clinical Trials | Cape Town | Western Cape | 7572 | South Africa |
| Netcare Alberton Hospital | Alberton | 1449 | South Africa |
| Soonchunhyang University Hospital | Cheonan | Chungcheongnam-do | 31151 | South Korea |
| Korea University Ansan Hospital | Ansan | Gyeonggi-do | 15355 | South Korea |
| The Catholic University of Korea, Bucheon ST. Mary's Hospital | Bucheon-si | Gyeonggi-do | 14647 | South Korea |
| Seoul National University Bundang Hospital_Seongnam-si | Seongnam-si | 463-707 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Seoul Saint Mary's Hospital | Seoul | 06591 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | 06591 | South Korea |
| Nowon Eulji Medical Center, Eulji University | Seoul | 139-827 | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| Changhua Christian Hospital_Metabolic Dept. | Changhua | 500 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| Chi Mei Medical Center | Tainan | 710 | Taiwan |
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
| Ankara Üniversitesi Tıp Fakültesi İbni Sina Hastanesi-Endokrinoloji | Ankara | Altindag | 06230 | Turkey (Türkiye) |
| Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Endokrinoloji | Adana | 01150 | Turkey (Türkiye) |
| Gulhane Egitim Arastirma Hastanesi | Ankara | 06010 | Turkey (Türkiye) |
| Haseki Eğitim ve Araştırma Hastanesi- Dahiliye | Istanbul | 34098 | Turkey (Türkiye) |
| Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye | Istanbul | 34722 | Turkey (Türkiye) |
| T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi | Istanbul | 34899 | Turkey (Türkiye) |
| Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye | Tekirdağ | 59030 | Turkey (Türkiye) |
Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks.
| Treated |
|
| Full Analysis Set |
|
| Safety Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all randomised participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Insulin Icodec | Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set (FAS) included all randomised participants. Overall number of participants analyzed = participants with available data. | Posted | Mean | Standard Deviation | Percentage point of HbA1c | Baseline (Week 0), Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Posted | Mean | Standard Deviation | Kilogram (Kg) | Baseline (Week 0), Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety analysis set (SAS) included all randomised participants who are exposed to randomised treatment. | Posted | Number | Episodes | From baseline week 0 to week 57 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Posted | Mean | Standard Deviation | Percentage of time | From week 48 to week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Posted | Mean | Standard Deviation | Percentage of time | From week 48 to week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Posted | Mean | Standard Deviation | Percentage of time | From week 48 to week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS included all randomised participants. Overall number of participants analyzed = participants with available data. | Posted | Mean | Standard Deviation | Millimoles per litre (mmol/L) | Baseline (Week 0), Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | SAS included all randomised participants who are exposed to randomised treatment. Overall number of participants analyzed = participants with available data. | Posted | Mean | Standard Deviation | Units of insulin | From week 50 to week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | SAS included all randomised participants who are exposed to randomised treatment. | Posted | Number | Episodes | From baseline week 0 to week 57 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | SAS included all randomised participants who are exposed to randomised treatment. | Posted | Number | Episodes | From baseline week 0 to week 57 |
|
|
Week 0 to week 57
Presented AEs are TEAEs, defined as event with onset during on treatment period where all data from date of first dose of randomised treatment as recorded on electronic case report form 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Icodec | Participants received once-weekly subcutaneous injections of 700 U/mL of insulin icodec for 52 weeks. | 3 | 645 | 69 | 644 | 258 | 644 |
| EG001 | 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. | 2 | 646 | 59 | 644 | 354 | 644 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA 26 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 26 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 26 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 26 | Systematic Assessment |
| |
| Breast haematoma | Reproductive system and breast disorders | MedDRA 26 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 26 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 26 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Degenerative aortic valve disease | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 26 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 26 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA 26 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 26 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26 | Systematic Assessment |
| |
| Osteoarthropathy | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 26 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 26 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Postrenal failure | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 26 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Terminal ileitis | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 26 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 26 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 26 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2022 | Mar 18, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712207 | insulin icodec |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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