A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)

Recruitment Status: COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified October 2025 by Novo Nordisk A/S
Sponsor: Novo Nordisk A/S
Information Provided by (Responsible Party): Novo Nordisk A/S

Clinicaltrials.gov Identifier: NCT04848480
Other Study ID Numbers:: NN1436-4625

First Submitted: April 15, 2021
First Posted: April 18, 2021
Results First Posted: April 22, 2025
Last Update Posted: December 3, 2025
Last Verified: October 2025

ClinicalTrials.gov processed this data on November 2025. Link to the current ClinicalTrials.gov record .

Study Details

Study Description

Condition or Disease	Intervention/Treatment
Diabetes Mellitus, Type 1	Drug: insulin icodecDrug: insulin degludec

Study Design

Study Type	Interventional
Actual Enrollment	582 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Official Title	Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety
Study Start Date	April 29, 2021
Actual Primary Completion Date	April 27, 2022
Actual Study Completion Date	December 1, 2022

Groups and Cohorts

Group/Cohort	Intervention/Treatment
Insulin icodec + insulin aspart insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.	Drug: insulin icodec insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly
Insulin degludec + insulin aspart insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times.	Drug: insulin degludec insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily

Outcome Measures

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c) at Week 26
Change in HbA1c from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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.

Secondary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c) at Week 52
Change in HbA1c from baseline to week 52 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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.
Change in Fasting Plasma Glucose (FPG)
Change in FPG from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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.
Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System
Percentage of time in range 3.9-10.0 mmol/L (70-180 mg/dL) using CGM system from week 22 to week 26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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.
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction
Change in DTSQs in total treatment satisfaction from baseline to week 26 is presented. The sum score for DTSQ in total treatment satisfaction was calculated by adding the six item scores of items 1, 4, 5, 6, 7 and 8. The sum score for DTSQ can range from 0 to 36, with 0 being the lowest and 36 being the highest score in total treatment satisfaction. Higher scores on the DTSQ total score indicate higher treatment satisfaction. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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.
Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26
Number of severe hypoglycaemic episodes (level 3) from baseline to week 26 are presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: the end date of the on-treatment period; week 26. On-treatment: 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. Data reflects total number of episodes across all participants within the arm.
Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57
Number of severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by Blood Glucose [BG] Meter): From Baseline (Week 0) to Week 26
Number of clinically significant hypoglycaemic episodes (level 2) from baseline to week 26 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Data is reported for 'main-on-treatment' period. The main-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 date of the on-treatment period; week 26. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by BG Meter): From Baseline (Week 0) to Week 57
Number of clinically significant hypoglycaemic episodes (level 2) from baseline to week 57 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Data is reported for 'on-treatment' period. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26
Number of clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 26 presented. Clinically significant hypoglycaemia (level 2) is de-fined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypo-glycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring ex-ternal assistance for recovery. Data is reported for 'main-on-treatment' period, started at date of first dose of trial product as recorded on eCRF, and ended at first date of any of following: end date of on-treatment period; week 26. On-treatment period: Onset date on or after the first dose of trial product and no later than 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. Data reflects total number of episodes across all participants within the arm.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57
Number of clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.
Number of Nocturnal Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26
Number of nocturnal clinically significant hypoglycaemic episodes (level 2) or severe hypogly-caemic episodes (level 3) from baseline to week 26 presented. Nocturnal: Period between 00:01 and 05:59 (both included). Clinically significant hypoglycaemia (level 2): Plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3): Hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period, started at date of first dose of trial product as recorded on eCRF, and ended at first date of any of following: end date of on-treatment period; week 26. On-treatment period: Onset date on or after first dose of trial product and no later than first date of either fol-low-up visit, last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or end-date for in-trial period. Data reflects total number of episodes across all participants within the arm.
Number of Nocturnal Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57
Number of nocturnal clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Nocturnal: The period between 00:01 and 05:59 (both included). Clinically significant hypoglycaemia (level 2): Plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3): Hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: 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. Data reflects total number of episodes across all participants within the arm.
Percentage of Time Spent Less Than (<) 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System
Percentage of time spent \< 3.0 mmol/L using CGM system from week 22 to week 26 is presented. Time spent below threshold (\< 3.0 mmol/L \[54 mg/dL\]) was defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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.
Percentage of Time Spent Greater Than (>) 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System
Percentage of time spent \> 10 mmol/L using CGM system from week 22 to week 26 is presented. Time spent above threshold (\> 10 mmol/L \[180 mg/dL\]) was defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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.
Mean Total Weekly Insulin Dose: From Week 24 to Week 26
Mean total weekly insulin dose from week 24 to week 26 is presented. Data is reported for 'main-on-treatment' period. The main-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 date of the on-treatment period; week 26. The on-treatment period: 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.
Mean Total Weekly Insulin Dose: From Week 50 to Week 52
Mean total weekly insulin dose from week 50 to week 52 is presented. Data is reported for 'on-treatment' period. The on-treatment period: 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.
Change in Body Weight
Change in body weight from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation 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.

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	Male or female aged greater than or equal to 18 years at the time of signing informed consent. Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening. Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening. HbA1c below10% at screening visit based on analysis from central laboratory.
Exclusion Criteria	Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. Chronic heart failure classified as New York Heart Association (NYHA) Class IV at screening. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids). Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Contacts and Locations

Sponsors and Collaborators	Novo Nordisk A/S
Locations	John Muir Physicians Network \| Concord California, United States, 94520Headlands Research California, LLC \| Escondido California, United States, 92025Valley Research \| Fresno California, United States, 93720Scripps Whittier Diabetes Inst \| La Jolla California, United States, 92037Diabetes & Endocrine Associates \| La Mesa California, United States, 91942Mills-Peninsula Hlth Services \| San Mateo California, United States, 94401Diablo Clinical Research, Inc. \| Walnut Creek California, United States, 94598Barbara Davis Center \| Aurora Colorado, United States, 80045Creekside Endocrine Associates, PC \| Denver Colorado, United States, 80246Christiana Care Health Services, Inc. \| Newark Delaware, United States, 19713Northeast Research Institute \| Fleming Island Florida, United States, 32003Center For Diabetes & Endo Care \| Fort Lauderdale Florida, United States, 33312Hanson Clinical Research Center \| Port Charlotte Florida, United States, 33952Northeast Research Institute \| Saint Augustine Florida, United States, 32080Physicians Research Assoc. LLC \| Lawrenceville Georgia, United States, 30046Endo Res Solutions Inc \| Roswell Georgia, United States, 30076Northwestern University_Chicago \| Chicago Illinois, United States, 60611The University of Chicago \| Chicago Illinois, United States, 60637Cotton-O'Neil Diab & Endo Ctr \| Topeka Kansas, United States, 66606Endo and Metab Consultants \| Rockville Maryland, United States, 20852Brigham & Women's Hospital \| Boston Massachusetts, United States, 02115MassResearch, LLC \| Waltham Massachusetts, United States, 02453Minn Center For Obesity Met & Endocrinology \| Eagan Minnesota, United States, 55123International Diabetes Center \| Minneapolis Minnesota, United States, 55416Jefferson City Medical Group, PC \| Jefferson City Missouri, United States, 65109Mercy Research \| Springfield Missouri, United States, 65807Methodist Physicians Clin \| Omaha Nebraska, United States, 68114Palm Research Center Inc-Vegas \| Las Vegas Nevada, United States, 89128Southern NH Diabetes and Endo_Nashua \| Nashua New Hampshire, United States, 03060John J Shelmet, MD \| Lawrenceville New Jersey, United States, 08648AMC Community Endocrinology \| Albany New York, United States, 12203Accellacare \| Wilmington North Carolina, United States, 28401Prisma Health-Upstate \| Greenville South Carolina, United States, 29605-4254Univ Diab & Endo Consultants \| Chattanooga Tennessee, United States, 37411Amarillo Med Spec LLP \| Amarillo Texas, United States, 79106Texas Diab & Endo, P.A. \| Austin Texas, United States, 78731Texas Diab & Endo, P.A. \| Austin Texas, United States, 78749Velocity Clinical Res-Dallas \| Dallas Texas, United States, 75230North Texas Endocrine Center \| Dallas Texas, United States, 75231PlanIt Research, PLLC \| Houston Texas, United States, 77079NE Clin Res of San Antonio \| San Antonio Texas, United States, 78233Rainier Clin Res Ctr Inc \| Renton Washington, United States, 98057Univ.-Klinik für Innere Medizin \| Graz , Austria, 8036Univ.-Klinik für Innere Medizin I \| Innsbruck , Austria, 6020Fließer-Görzer [Ordination] \| Saint Stefan , Austria, 8511Klinik Landstraße \| Vienna , Austria, 1030Universitätsklinikum AKH Wien \| Vienna , Austria, 1090Klinik Hietzing \| Vienna , Austria, 1130Winnipeg Clinic \| Winnipeg Manitoba, Canada, R3C 0N2Eastern Health Authority \| St. John's Newfoundland and Labrador, Canada, A1B 3V6Nova Scotia Hlth Halifax \| Halifax Nova Scotia, Canada, B3H 1V7LMC Clinical Res Thornhill \| Concord Ontario, Canada, L4K 4M2St. Joseph's Health Care \| London Ontario, Canada, N6A 4V2Centricity Research LMC \| Toronto Ontario, Canada, M4G 3E8Ctr de rech Clin de Laval \| Laval Quebec, Canada, H7T 2P5IRCM \| Montreal Quebec, Canada, H2W 1R7Centre de recherché du CHUS \| Sherbrooke Quebec, Canada, J1H 5N4CHU de Quebec-Universite Laval \| Québec , Canada, G1V 4G2Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR \| Berlin , Germany, 13597InnoDiab Forschung GmbH \| Essen , Germany, 45136Zentrum für klinische Forschung, Dr. med. Lüdemann \| Falkensee , Germany, 14612Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz \| Lingen , Germany, 49808Die Praxis am Ludwigsplatz \| Ludwigshafen , Germany, 67059Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck \| Lübeck , Germany, 23538Institut für Diabetesforschung GmbH Münster - Dr. med. Rose \| Münster , Germany, 48145RED-Institut für medizinische Studien und Fortbildung GmbH \| Oldenburg I. Holst , Germany, 23758RED-Institut für medizinische Forschung und Fortbildung GmbH \| Oldenburg in Holstein , Germany, 23758Zentrum für klinische Studien Alexander Segner \| Saint Ingbert-Oberwürzbach , Germany, 66386Diacare diabetes Hormonal Clinic \| Ahmedabad Gujarat, India, 380 015Calicut Medical College \| Kozhikode Kerala, India, 673008All India Institute of Medical Sciences \| New Dehli New Delhi, India, 110029Post Graduate Institute of Medical Education & Research \| Chandigarh Punjab, India, 160012Fortis Heart Institute and Multispeciality Hospital \| Mohali Punjab, India, 160062Care Hospital \| Hyderabad , India, 600034Lady Hardinge Medical College \| New Delhi , India, 110001Jothydev's Diabetes & Research Center \| Thriruvananthapuram , India, 695 032Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia \| Perugia Umbria, Italy, 06129Policlinico Mater Domini Università di Catanzaro \| Catanzaro , Italy, 88100Azienda Ospedaliero Universitaria Careggi MASTER \| Florence , Italy, 50134Osp. San Raffaele Diabetes Research Institute, Dibit 1 \| Milan , Italy, 20132Policlinico Umberto I Clinica Medica DH Diabetologia \| Roma , Italy, 00161Master Centre for Italy \| Rome , Italy, 00144Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche \| Rome , Italy, 00168Seino Internal Medicine Clinic_Internal medicine \| Koriyama-shi Fukushima, Japan, Japan, 963-8851Manda Memorial Hospital_Internal Medicine \| Sapporo-shi, Hokkaido Hokkaido, Japan, Japan, 060-0062Jinnouchi Hospital_Internal Medicine \| Kumamoto Kumamoto, Japan, Japan, 862-0976The Institute of Medical Science, Asahi Life Foundation_Internal Medicine \| Chuo-ku, Tokyo , Japan, 103-0002H.E.C Science Clinic \| Kanagawa , Japan, 235-0045Yuri Ono Clinic \| Sapporo-shi, Hokkaido , Japan, 060-0001Tokyo Women's Medical University_Metabolism and Diabetology \| Tokyo , Japan, 162 8666Gelre Ziekenhuizen Apeldoorn \| Apeldoorn , Netherlands, 7334 DZRijnstate Ziekenhuis \| Arnhem , Netherlands, 6815 ADMaxima Medisch Centrum \| Eindhoven , Netherlands, 5631 BMBethesda Diabetes Research Center en Bethesda ziekenhuis \| Hoogeveen , Netherlands, 7909 AAMaastricht Universitair Medisch Centrum \| Maastricht , Netherlands, 6229 HXIkazia Ziekenhuis \| Rotterdam , Netherlands, 3083 ANUniversitair Medisch Centrum Utrecht \| Utrecht , Netherlands, 3584 CXVolosevich First City Clinical Hospital \| Arkhangelsk , Russia, 163001LLC "Clinic of new technologies in Medicine" \| Dzerzhinskiy , Russia, 140091FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia \| Moscow , Russia, 117292Endocrinological Dispensary of Department of healthcare ser. \| Moscow , Russia, 119034Endocrinology Dpt,Post-Graduate Medical Education Faculty \| Moscow , Russia, 123448SPb SBHI "Snegirev Maternity Hospital No. 6" \| Saint Petersburg , Russia, 191014City Consultative & Diagnostic Centre #1 \| Saint Petersburg , Russia, 194354SPb SBHI City Multifield Hospital #2 \| Saint Petersburg , Russia, 194354SPb SBHI City polyclinic #117 \| Saint Petersburg , Russia, 194358LLC "Endocrinolog" \| Samara , Russia, 443031SHI Saratov City Clinical Hospital #9 \| Saratov , Russia, 410031Saratov regional clinical hospital \| Saratov , Russia, 410053Voronezh Regional Clinical Consultive-diagnostic Centre \| Voronezh , Russia, 394018Yaroslavl Regional Hospital \| Yaroslavl , Russia, 150062Hospital Clinic i Provincial \| Barcelona , Spain, 08036Hospital Clinico Virgen de la Victoria \| Málaga , Spain, 29010Hospital Univ. Central de Asturias \| Oviedo , Spain, 33011Clínica Nuevas Tecnologías en Diabetes y Endocrinología \| Seville , Spain, 41003Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Endokrinoloji \| Adana , Turkey (Türkiye), 01150Aydın Adnan Menderes Üniversitesi Hastanesi \| Aydin , Turkey (Türkiye), 09010Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji \| Istanbul , Turkey (Türkiye), 34371Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi- Endokrinoloji \| Istanbul , Turkey (Türkiye), 34400Haydarpaşa Numune Eğitim ve Araştırma Hastanesi - Endokrinoloji \| Istanbul , Turkey (Türkiye), 34668Erciyes Üniversitesi Hastanesi- Nefroloji \| Kayseri , Turkey (Türkiye), 38039İnönü Üniversitesi Turgut Özal Tıp Merkezi - Kardiyoloji \| Malatya , Turkey (Türkiye), 44280Southmead Hospital \| Bristol , United Kingdom, BS10 5NBAddenbrooke's Hospital_Cambridge \| Cambridge , United Kingdom, CB2 0QQRoyal Derby Hospital \| Derby , United Kingdom, DE1 2QYWestern General Hospital \| Edinburgh , United Kingdom, EH4 2XURoyal Surrey County Hospital - Diabetes \| Guildford , United Kingdom, GU2 7XXChurchill Hospital \| Oxford , United Kingdom, OX3 7LELister Hospital \| Stevenage , United Kingdom, SG1 4ABJoint Clinical Research Facility - Swansea \| Swansea , United Kingdom, SA2 8PP
Investigators	Study Director: Clinical Transparency (1452), Novo Nordisk A/S

Study Documents (Full Text)

Documents provided by Novo Nordisk A/S: Study Protocol June 26, 2022Documents provided by Novo Nordisk A/S: Statistical Analysis Plan April 14, 2021

More Information

Publications

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. 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. 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. Russell-Jones D, Babazono T, Cailleteau R, Engberg S, Irace C, Kjaersgaard MIS, Mathieu C, Rosenstock J, Woo V, Klonoff DC. Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial. Lancet. 2023 Nov 4;402(10413):1636-1647. doi: 10.1016/S0140-6736(23)02179-7. Epub 2023 Oct 17.

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 1Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases