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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1247-3878 | Other Identifier | World Health Organization (WHO) | |
| 2020-000442-34 | EudraCT Number |
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This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.
The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance.
The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.
Participants will be asked to wear a sensor that measures the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin icodec | Experimental | Insulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period |
|
| Insulin glargine | Active Comparator | Insulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | Change in HbA1c from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | Baseline (week 0), Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using CGM system from week 48 to week 52 is presented. Time in target range is defined as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uni of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Lakeview Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36106652 | Result | Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14. | |
| 41051694 |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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The trial was conducted at 137 sites in 12 countries while 141 sites screened participants. The total number of sites per country that screened and randomised participants are as follows (number of sites that screened participants/number of sites that randomised participants): Croatia (4/4), India (9/9), Israel (5/5), Italy (5/5), Japan (14/14), Mexico (3/3), Poland (8/8), Russia (14/14), Slovakia (7/7), Spain (5/5), United Kingdom (11/11), United States (56/52)
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Icodec | Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 units. |
| 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 | Nov 30, 2020 | May 26, 2025 |
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| Insulin glargine | Drug | Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks |
|
| 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 data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | Baseline (week 0), Week 52 |
| Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 52 | Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period. | From baseline (week 0) to week 52 |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 mg/dL] Confirmed by Blood Glucose [BG] Meter) Until Week 52 | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period. | From baseline (week 0) to week 52 |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) Until Week 52 | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period. | From baseline (week 0) to week 52 |
| Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 83 | Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a subject was considered exposed to trial product. | From baseline (week 0) to week 83 |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL) Confirmed by BG Meter) Until Week 83 | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a subject was considered exposed to trial product. | From baseline (week 0) to week 83 |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) Until Week 83 | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. On-treatment period started at the date of first dose of trial product as recorded on the eCRF and ended at the first date of any of the following: The end of trial visit (V63), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. On-treatment period was the period in which a participant was exposed to trial product. | From baseline (week 0) to week 83 |
| Mean Weekly Insulin Dose | Mean weekly insulin dose from week 50 to week 52 is presented. The outcome data was evaluated based on main on treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit, the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period. | From week 50 to week 52 |
| Change in Body Weight | Change in body weight from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | Baseline (week 0), Week 52 |
| Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent < 3.0 mmol/L (54 mg/dL) from week 48 to week 52 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | From week 48 to week 52 |
| Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent > 10 mmol/L (180 mg/dL) is presented. 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 data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | From week 48 to week 52 |
| Guntersville |
| Alabama |
| 35976 |
| United States |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72204 | United States |
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
| Advanced Clinical Research/Rancho Paseo Medical Group | Banning | California | 92220 | United States |
| American Clinical Trials | Buena Park | California | 90620 | United States |
| San Fernando Valley Hlth Inst, LLC | Canoga Park | California | 91304 | United States |
| Med Center Medical Clinic | Carmichael | California | 95608 | United States |
| Headlands Research California, LLC | Escondido | California | 92025 | United States |
| Valley Research | Fresno | California | 93720 | United States |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | United States |
| First Valley Medical Group | Lancaster | California | 93534 | United States |
| Clinical Trials Research_Sacramento | Lincoln | California | 95648 | United States |
| Torrance Clin Res Inst, Inc. | Lomita | California | 90717 | United States |
| Providence Clinical Research | North Hollywood | California | 91606 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 92262 | United States |
| NorCal Endocrinology and Internal Medicine_Roseville | Roseville | California | 95661 | United States |
| Diabetes Research Center | Tustin | California | 92780 | United States |
| Coastal Metabolic Research Center | Ventura | California | 93003 | United States |
| Denver Endocrinology Diabetes and Thyroid Center | Englewood | Colorado | 80113 | United States |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | United States |
| Revival Research | Doral | Florida | 33122 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32216 | United States |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | United States |
| University Of Miami | Miami | Florida | 33136 | United States |
| Suncoast Clin Res Port Richey | New Port Richey | Florida | 34652 | United States |
| Florida Inst For Clin Res | Orlando | Florida | 32825 | United States |
| Palm Harbor Medical Associates | Palm Harbor | Florida | 34684-3609 | United States |
| Suncoast Clinical Research, Inc. | Palm Harbor | Florida | 34684 | United States |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | United States |
| Clinical Research of Cent FL | Winter Haven | Florida | 33880 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Physicians Research Assoc. LLC | Lawrenceville | Georgia | 30046 | United States |
| RNA America Health Sciences | Sugar Hill | Georgia | 30518 | United States |
| East West Medical Research Institute_Honolulu | Honolulu | Hawaii | 96814 | United States |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | United States |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Clinical Invest Special_Gurnee | Gurnee | Illinois | 60031 | United States |
| Central Illinois Diabetes and Clinical Research | Springfield | Illinois | 62711 | 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 |
| St Elizabeth Physicians Heart | Covington | Kentucky | 41011 | United States |
| Four Rivers Clinical Research Inc | Paducah | Kentucky | 42001 | United States |
| MedStar Hlth Res Institute | Hyattsville | Maryland | 20782 | United States |
| Endo And Metab Cons | Rockville | Maryland | 20852 | United States |
| Arcturus Healthcare, PLC. | Troy | Michigan | 48098 | United States |
| Diabetes & Endo Specialists Inc | Chesterfield | Missouri | 63017 | United States |
| Methodist Phys. Clinic | Omaha | Nebraska | 68114 | United States |
| Univ of Nebraska Medical CTR | Omaha | Nebraska | 68198-3020 | United States |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89128 | United States |
| Southern NH Diabetes and Endo_Nashua | Nashua | New Hampshire | 03060 | United States |
| Albuquerque Clin Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| N.Y. Total Medical Care PC | Brooklyn | New York | 11215 | United States |
| Northwell Health Div of Endo | Great Neck | New York | 11021 | United States |
| NYU Grossman School of Med | New York | New York | 10016 | United States |
| Endocrine Associates of Long Island, PC | Smithtown | New York | 11787 | United States |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Physicians East Endocrinology | Greenville | North Carolina | 27834 | United States |
| Medication Management, LLC | Raleigh | North Carolina | 27609 | United States |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| Ardmore Family Practice | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Plains Clinical Research Center, LLC | Fargo | North Dakota | 58104 | United States |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | United States |
| Providence Health Partners Ctr | Dayton | Ohio | 45439 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Your Diabetes Endocrine Nutrition Group, Inc. | Mentor | Ohio | 44060 | United States |
| Clinical Research Source Inc | Perrysburg | Ohio | 43551 | United States |
| Intend Research | Norman | Oklahoma | 73069 | United States |
| Oregon Health & Science University_Portland | Portland | Oregon | 97239-3098 | United States |
| Heritage Valley Medical Group Inc | Beaver | Pennsylvania | 15009 | United States |
| Indiana-Armstrong Endocrinology Associates | Indiana | Pennsylvania | 15701 | United States |
| The Diabetes Center, LLC | Murrells Inlet | South Carolina | 29576 | United States |
| Hillcrest Clinical Research | Simpsonville | South Carolina | 29681-1538 | United States |
| AM Diabetes And Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Texas Diab & Endo, P.A. | Austin | Texas | 78731 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| UT Southwestern Med Cntr | Dallas | Texas | 75390-9302 | United States |
| PrimeCare Medical Group | Houston | Texas | 77024 | United States |
| JCCT- Juno NW Houston | Houston | Texas | 77040 | United States |
| Fmc Science, Llc | Lampasas | Texas | 76550 | United States |
| Texas Diab & Endo, P.A. | Round Rock | Texas | 78681 | United States |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | United States |
| NE Clin Res of San Antonio | San Antonio | Texas | 78233 | United States |
| Simcare Medical Research, LLC | Sugar Land | Texas | 77478 | United States |
| Elite Medical Care | Sugar Land | Texas | 77479 | United States |
| Wade Family Medicine | Bountiful | Utah | 84010 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Danville Internal Medicine Inc | Danville | Virginia | 24541-2834 | United States |
| TPMG Clinical Research | Newport News | Virginia | 23606 | United States |
| Rainier Clin Res Ctr Inc | Renton | Washington | 98057 | United States |
| Poliklinika SLAVONIJA OSIJEK | Osijek | County of Osijek-Baranja | 31000 | Croatia |
| Opca bolnica Karlovac | Karlovac | 47000 | Croatia |
| KBC Rijeka, Endokrinologija | Rijeka | 51000 | Croatia |
| Opca bolnica Varazdin_Endocrinology | Varaždin | 42 000 | Croatia |
| PGIMS Rohtak | Rohtak | Haryana | 124001 | India |
| TOTALL Diabetes Hormone Institute | Indore | Madhya Pradesh | 452010 | 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 |
| chelleram Diabetes Institute | Pune | Maharashtra | 411021 | India |
| All India Institute of Medical Sciences | New Dehli | New Delhi | 110029 | India |
| Madras Diabetes Research Foundation | Chennai | Tamil Nadu | 600086 | India |
| Christian Medical College Hospital, Vellore | Vellore | Tamil Nadu | 632004 | India |
| Gandhi Hospital & Medical college | Hyderabad | Telangana | 500003 | India |
| Osmania General Hospital | Hyderabad | Telangana | 500012 | India |
| Ramdev Rao Hospital | Hyderabad | Telangana | 500072 | India |
| SSKM | Kolkata | West Bengal | 700020 | India |
| Soroka MC - Outpatient Diabetes Clinic | Beersheba | 84101 | Israel |
| Wolfson MC - Diabetes Clinic | Holon | 58100 | Israel |
| Hadassah Ein Karam MC - Diabetes Unit | Jerusalem | 91120 | Israel |
| Diabetes Clinic Meir MC | Kfar Saba | 44281 | Israel |
| Rabin MC Beilinson - Department of Cardiothoracic Surgery | Petah Tikva | 49100 | Israel |
| Kaplan MC - Metabolic Unit | Rehovot | 76100 | Israel |
| Policlinico Umberto I Seconda Clinica Medica | Roma | RM | 00161 | Italy |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Policlinico Mater Domini Università di Catanzaro | Catanzaro | 88100 | Italy |
| Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia | Milan | 20122 | Italy |
| Policlinico Universitario Paolo Giaccone | Palermo | 90127 | Italy |
| 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 |
| Heiwadai Hospital_Internal Medicine | Miyazaki | Miyazaki | 880-0034 | Japan |
| The University of Tokyo Hospital, Diabetes and Metabolic | Bunkyo-ku, Tokyo | 113-8655 | Japan |
| Tokuyama clinic_Diabetic internal medicine | Chiba | 261-0004 | Japan |
| Futata Tetsuhiro Clinic Meinohama_Internal medicine | Fukuoka-shi, Fukuoka | 819-0006 | Japan |
| Naka Kinen Clinic_Internal medicine | Ibaraki | 311-0113 | Japan |
| Sugimoto Clinic,Internal Medicine | Kitakyusyu-shi, Fukuoka | 800-0222 | Japan |
| Toranomon Hospital, Endocrinology and Metabolism | Minato-ku, Tokyo | 105-8470 | Japan |
| Shinden Higashi Clinic_Miyagi | Miyagi | 983-0039 | Japan |
| Takatsuki Red Cross Hospital_Diabetes and Endocrine Div. | Osaka | 569-1045 | Japan |
| Shimizu Clinic Fusa | Saitama | 336-0967 | Japan |
| Wakakusa Clinic | Shimotsuke-shi, Tochigi | 329-0433 | Japan |
| Oyama East Clinic_Internal Medicine | Tochigi | 323-0022 | Japan |
| Noritake Clinic | Ushiku-shi, Ibaraki | 300-1207 | Japan |
| InstitutoJalisciense de Investigación en Diabetes y Obesidad | Guadalajara | Jalisco | 44600 | Mexico |
| Clínica Omega Diabetes, S.C. | Mexico City | México, D.F. | 06700 | Mexico |
| Hospital Universitario Dr. José Eleuterio González_Monterrey | Monterrey | Nuevo León | 64460 | Mexico |
| Investigación Médica Sonora S.C. | Hermosillo | Sonora | 83280 | Mexico |
| NZOZ Przychodnia Specjalistyczna Medica | Lublin | Lubelski | 20-538 | Poland |
| NZOZ "CenterMed Lublin" Sp. z o.o. | Lublin | Lublin Voivodeship | 20-044 | Poland |
| Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski | Gorzów Wielkopolski | Lubusz Voivodeship | 66-400 | Poland |
| NBR Polska Tomasz Klodawski | Warsaw | Masovian Voivodeship | 00-710 | Poland |
| NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska | Bialystok | Podlaskie Voivodeship | 15-435 | Poland |
| Centrum Medyczne "Diabetika" | Radom | 26-600 | Poland |
| Centrum Zdrowia Tuchow Sp z o.o. | Wierzchosławice | 33-122 | Poland |
| Prywatny Gabinet Janusz Gumprecht | Zabrze | 41-800 | Poland |
| Advanced Clinical Research LLC | Bayamón | 00959 | Puerto Rico |
| Manati Ctr For Clin Research | Manati | 00674 | Puerto Rico |
| Consultorio Medico | San Juan | 00921 | Puerto Rico |
| SAHI Kuzbass Hospital(former Regional clinical hospital) | Kemerovo | 650066 | Russia |
| FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia | Moscow | 117292 | Russia |
| Setchenov First Moscow State Medical University | Moscow | 119435 | Russia |
| Limited Law Company "Healthy Family" Medicine Center" | Novosibirsk | 630099 | Russia |
| Scientifc Institute of Clinical and Experimental Lymphology | Novosibirsk | 630117 | Russia |
| Penza Regional Clinical Hospital named after N.N. Burdenko | Penza | 440052 | Russia |
| Limited Liability Company "Energiya Zdoroviya" | Saint Petersburg | 194156 | Russia |
| Leningrad Regional Clinical Hospital | Saint Petersburg | 194291 | Russia |
| Medinet LLC | Saint Petersburg | 194356 | Russia |
| Consultative & Diagnostic Center with a Outpatient Hospital | Saint Petersburg | 197110 | Russia |
| Regional clinical cardiology dispensary | Saratov | 410039 | Russia |
| Siberian State Medical University | Tomsk | 634050 | Russia |
| Voronezh Regional Clinical Consultive-diagnostic Centre | Voronezh | 394018 | Russia |
| Polyclinic #2 in Yoshkar-Ola | Yoshkar-Ola | 424004 | Russia |
| Peter Farkas MD, s.r.o. | Šahy | Slovak Republic | 93601 | Slovakia |
| Amb. diabetologie a poruch latkovej premeny a vyzivy | Bratislava | 821 02 | Slovakia |
| Diacrin s. r. o. | Bratislava | 84102 | Slovakia |
| MEDISPEKTRUM s.r.o. | Bratislava | 851 01 | Slovakia |
| MediVet s.r.o. | Malacky | 901 01 | Slovakia |
| SIN AZUCAR s.r.o. | Malacky | 901 01 | Slovakia |
| Diabetologicka ambulancia SchronerMED, s.r.o. | Moldava nad Bodvou | 045 01 | Slovakia |
| ARETEUS s.r.o. | Trebišov | 07501 | Slovakia |
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| ABS La Roca del Vallés_Endocrinología | La Roca Del Vallés | 08430 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Centro de Especialidades José Marva | Madrid | 28020 | Spain |
| Hospital Quirón | Pozuelo de Alarcón | 28223 | Spain |
| Hospital Universitario Quirónsalud Madrid | Pozuelo de Alarcón | 28223 | Spain |
| Bollington Medical Centre | Bollington | Cheshire | SK10 5JH | United Kingdom |
| Layton Medical Centre | Blackpool | FY3 7EN | United Kingdom |
| The Health Centre | Bradford-on-Avon | BA15 1DQ | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Addenbrooke's Hospital_Cambridge | Cambridge | CB2 0QQ | United Kingdom |
| Countess of Chester Hospital | Chester | CH2 1UL | United Kingdom |
| The Adam Practice | Dorset | BH16 5PW | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Wycombe General Hospital | High Wycombe | HP11 2TT | United Kingdom |
| Burbage Surgery | Hinckley | LE10 2SE | United Kingdom |
| Queen Alexandra Hospital_Portsmouth | Portsmouth | PO6 3LY | United Kingdom |
| The Staploe Medical Centre | Soham | CB7 5JD | United Kingdom |
| Joint Clinical Research Facility - Swansea | Swansea | SA2 8PP | United Kingdom |
| Royal Cornwall Hospital (Treliske) | Truro | TR1 3LJ | United Kingdom |
| Albany House Medical Centre | Wellingborough | NN8 4RW | United Kingdom |
| Mohan V, Kesavadev J, Murthy LS, Anil G, Chandrappa M, Kar S, Mishra S. Efficacy and Safety of Once-Weekly Insulin Icodec in Indian Participants with Diabetes: Results from ONWARDS 1, 4, and 6 Studies. Diabetes Ther. 2025 Nov;16(11):2193-2212. doi: 10.1007/s13300-025-01799-4. Epub 2025 Oct 6. |
| 40465144 | Derived | Philis-Tsimikas A, Krogsdahl Bache J, Fu A, Kellerer M, Salvesen-Sykes K, Bain SC. Insights on Hospitalisations from the Phase 3a ONWARDS 1-6 Trials of Once-Weekly Insulin Icodec. Diabetes Ther. 2025 Aug;16(8):1615-1631. doi: 10.1007/s13300-025-01745-4. Epub 2025 Jun 4. |
| 40186685 | Derived | Riddell MC, Heller S, Carstensen L, Rocha TMP, Kehlet Watt S, Woo VC. The effect of once-weekly insulin icodec vs once-daily basal insulin on physical activity-attributed hypoglycaemia in type 2 diabetes: a post hoc analysis of ONWARDS 1-5. Diabetologia. 2025 Jul;68(7):1416-1422. doi: 10.1007/s00125-025-06414-6. Epub 2025 Apr 5. |
| 39374601 | Derived | Bergenstal RM, Asbjornsdottir B, Watt SK, Lingvay I, Mader JK, Nishida T, Rosenstock J. Continuous glucose monitoring-based metrics and the duration of hypoglycaemia events with once-weekly insulin icodec versus once-daily insulin glargine U100 in insulin-naive type 2 diabetes: an exploratory analysis of ONWARDS 1. Lancet Diabetes Endocrinol. 2024 Nov;12(11):799-810. doi: 10.1016/S2213-8587(24)00220-1. Epub 2024 Oct 4. |
| 39368488 | Derived | Polonsky W, Benamar M, Carstensen L, Davies M, Meller Donatsky A, Franek E, Kellerer M, Philis-Tsimikas A, Goldenberg R. Improved treatment satisfaction with once-weekly insulin icodec compared with once-daily basal insulin in individuals with type 2 diabetes: An analysis of patient-reported outcomes and participant interviews from ONWARDS 2 and 5 and a physician survey from ONWARDS 1. Diabetes Res Clin Pract. 2024 Nov;217:111885. doi: 10.1016/j.diabres.2024.111885. Epub 2024 Oct 4. |
| 39344833 | Derived | Watada H, Asbjornsdottir B, Nishida T, Nishimura R, Yamamoto Y, Yamauchi T, Kadowaki T. Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in Japanese individuals with type 2 diabetes: A subgroup analysis of the ONWARDS 1, 2 and 4 trials. Diabetes Obes Metab. 2024 Dec;26(12):5882-5895. doi: 10.1111/dom.15960. Epub 2024 Sep 30. |
| 37356066 | Derived | Rosenstock J, Bain SC, Gowda A, Jodar E, Liang B, Lingvay I, Nishida T, Trevisan R, Mosenzon O; ONWARDS 1 Trial Investigators. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. N Engl J Med. 2023 Jul 27;389(4):297-308. doi: 10.1056/NEJMoa2303208. Epub 2023 Jun 24. |
| FG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
| Full Analysis Set |
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| Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set included all randomised participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Icodec | Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 units. |
| BG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Glycated Haemoglobin (HbA1c) | Change in HbA1c from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | Full analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline (week 0), Week 52 |
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| Secondary | Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using CGM system from week 48 to week 52 is presented. Time in target range is defined as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | Full analysis set included all randomized participants. Overall number of participants analysed = Participants with available data for the outcome measure. | Posted | Mean | Standard Deviation | Percentage of time | From week 48 to week 52 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) | Change in FPG from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | Full analysis set included all randomized participants. Overall number of participants analysed = Participants with available data for the outcome measure. | Posted | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | Baseline (week 0), Week 52 |
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| Secondary | Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 52 | Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Episodes | From baseline (week 0) to week 52 |
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| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 mg/dL] Confirmed by Blood Glucose [BG] Meter) Until Week 52 | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Episodes | From baseline (week 0) to week 52 |
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| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) Until Week 52 | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Episodes | From baseline (week 0) to week 52 |
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| Secondary | Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 83 | Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a subject was considered exposed to trial product. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Episodes | From baseline (week 0) to week 83 |
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| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL) Confirmed by BG Meter) Until Week 83 | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a subject was considered exposed to trial product. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Episodes | From baseline (week 0) to week 83 |
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| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) Until Week 83 | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. On-treatment period started at the date of first dose of trial product as recorded on the eCRF and ended at the first date of any of the following: The end of trial visit (V63), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. On-treatment period was the period in which a participant was exposed to trial product. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Episodes | From baseline (week 0) to week 83 |
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| Secondary | Mean Weekly Insulin Dose | Mean weekly insulin dose from week 50 to week 52 is presented. The outcome data was evaluated based on main on treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit, the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Least Squares Mean | 95% Confidence Interval | Units of insulin | From week 50 to week 52 |
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| Secondary | Change in Body Weight | Change in body weight from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | Full analysis set included all randomized participants. | Posted | Least Squares Mean | Standard Error | kilograms (kg) | Baseline (week 0), Week 52 |
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| Secondary | Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent < 3.0 mmol/L (54 mg/dL) from week 48 to week 52 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | Full analysis set included all randomized participants. Overall number of participants analyzed=Participants with available data for the outcome measure. | Posted | Mean | Standard Deviation | Percentage of time | From week 48 to week 52 |
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| Secondary | Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent > 10 mmol/L (180 mg/dL) is presented. 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 data was evaluated based on the in-trial observation period. The in-trial period started at randomization and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit), death for participants who died before any of the above. | Full analysis set included all randomized participants. Overall number of participants analyzed=Participants with available data for the outcome measure. | Posted | Mean | Standard Deviation | Percentage of time | From week 48 to week 52 |
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From week 0 to week 83
Treatment emergent adverse events (TEAEs) are reported: event that had onset date during on-treatment period: started 1st dose date of trial product as recorded on eCRF, and ended at 1st date of any of following: end of trial V63, last date on trial product+5 weeks for once daily insulin and+6 weeks for once weekly insulin, end-date for in-trial observation period. Safety analysis set: all participants randomly assigned to trial treatment who took at least 1 dose of trial product.
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 | Insulin Icodec | Participants received once-weekly subcutaneous injection of insulin icodec at a starting dose of 70 U for 78 weeks using PDS 290 pre-filled injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 units. | 5 | 492 | 64 | 492 | 221 | 492 |
| EG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. | 4 | 492 | 71 | 492 | 216 | 492 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Atrioventricular block second degree | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 24 | Systematic Assessment |
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| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Brachiocephalic arteriosclerosis | Vascular disorders | MedDRA 24 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Cardiac stress test abnormal | Investigations | MedDRA 24 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 24 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Cervical radiculopathy | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Chronic coronary syndrome | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Chronic hepatitis C | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Colitis ischaemic | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA 24 | Systematic Assessment |
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| Deafness traumatic | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
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| Death | General disorders | MedDRA 24 | Systematic Assessment |
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| Diabetic retinal oedema | Eye disorders | MedDRA 24 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Electrolyte depletion | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Empyema | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 24 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 24 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 24 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Immunisation reaction | Immune system disorders | MedDRA 24 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Intestinal sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Ketonuria | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Myxoid cyst | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Open angle glaucoma | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Osteomyelitis chronic | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Periprocedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Post procedural stroke | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Presbyacusis | Ear and labyrinth disorders | MedDRA 24 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Removal of foreign body | Surgical and medical procedures | MedDRA 24 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Thrombotic stroke | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 24 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24 | 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 | Jan 11, 2021 | May 26, 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 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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 |
|
| Other |
|
| OG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
|
|
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U.
|
|
| OG001 |
| Insulin Glargine |
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
|
|
| OG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
|
|
| OG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
|
|
| OG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
|
|
| OG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
|
|
| OG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
|
|
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U.
|
|
|
|
| OG001 | Insulin Glargine | Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
|
|
| OG001 |
| Insulin Glargine |
Participants received once daily subcutaneous injection of insulin glargine at a starting dose of 10 U for 78 weeks using SoloSTAR pre-filled pen injector in combination with non-insulin anti-diabetic drugs. The dose adjustment was based on the three pre-breakfast self-monitored plasma glucose (SMPG) values measured on two days prior to titration and on the day of the contact. If atleast one pre-breakfast SMPG value was: < 4.4 mmol/L: the dose was reduced by 3 U; 4.4-7.2: no dose adjustment required and >7.2 mmol/L: dose was increased by 3 U. |
|
|