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)
NCT ID: NCT04848480
Last Updated: 2025-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
582 participants
INTERVENTIONAL
2021-04-30
2022-12-02
Brief Summary
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The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec 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 degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin.
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 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken.
At 6 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 your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year).
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin icodec + insulin aspart
insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.
insulin icodec
insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly
insulin aspart
insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily
Insulin degludec + insulin aspart
insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times.
insulin degludec
insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily
insulin aspart
insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily
Interventions
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insulin icodec
insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly
insulin degludec
insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily
insulin aspart
insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Klinik Landstraße
Vienna, , Austria
Universitätsklinikum AKH Wien
Vienna, , Austria
Klinik Hietzing
Vienna, , Austria
Winnipeg Clinic
Winnipeg, Manitoba, Canada
Eastern Health Authority
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
LMC Clinical Res Thornhill
Concord, Ontario, Canada
St. Joseph's Health Care
London, Ontario, Canada
Centricity Research LMC
Toronto, Ontario, Canada
Ctr de rech Clin de Laval
Laval, Quebec, Canada
IRCM
Montreal, Quebec, Canada
Centre de recherché du CHUS
Sherbrooke, Quebec, Canada
CHU de Quebec-Universite Laval
Québec, , Canada
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
Berlin, , Germany
InnoDiab Forschung GmbH
Essen, , Germany
Zentrum für klinische Forschung, Dr. med. Lüdemann
Falkensee, , Germany
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Lingen, , Germany
Die Praxis am Ludwigsplatz
Ludwigshafen, , Germany
Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
Lübeck, , Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, , Germany
RED-Institut für medizinische Studien und Fortbildung GmbH
Oldenburg I. Holst, , Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, , Germany
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, , Germany
Diacare diabetes Hormonal Clinic
Ahmedabad, Gujarat, India
Calicut Medical College
Kozhikode, Kerala, India
All India Institute of Medical Sciences
New Dehli, New Delhi, India
Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, India
Fortis Heart Institute and Multispeciality Hospital
Mohali, Punjab, India
Care Hospital
Hyderabad, , India
Lady Hardinge Medical College
New Delhi, , India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, , India
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
John Muir Physicians Network
Concord, California, United States
Headlands Research California, LLC
Escondido, California, United States
Valley Research
Fresno, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Diabetes & Endocrine Associates
La Mesa, California, United States
Mills-Peninsula Hlth Services
San Mateo, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
Christiana Care Health Services, Inc.
Newark, Delaware, United States
Northeast Research Institute
Fleming Island, Florida, United States
Center For Diabetes & Endo Care
Fort Lauderdale, Florida, United States
Hanson Clinical Research Center
Port Charlotte, Florida, United States
Northeast Research Institute
Saint Augustine, Florida, United States
Physicians Research Assoc. LLC
Lawrenceville, Georgia, United States
Endo Res Solutions Inc
Roswell, Georgia, United States
Northwestern University_Chicago
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Cotton-O'Neil Diab & Endo Ctr
Topeka, Kansas, United States
Endo and Metab Consultants
Rockville, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
MassResearch, LLC
Waltham, Massachusetts, United States
Minn Center For Obesity Met & Endocrinology
Eagan, Minnesota, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Jefferson City Medical Group, PC
Jefferson City, Missouri, United States
Mercy Research
Springfield, Missouri, United States
Methodist Physicians Clin
Omaha, Nebraska, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Southern NH Diabetes and Endo_Nashua
Nashua, New Hampshire, United States
John J Shelmet, MD
Lawrenceville, New Jersey, United States
AMC Community Endocrinology
Albany, New York, United States
Accellacare
Wilmington, North Carolina, United States
Prisma Health-Upstate
Greenville, South Carolina, United States
Univ Diab & Endo Consultants
Chattanooga, Tennessee, United States
Amarillo Med Spec LLP
Amarillo, Texas, United States
Texas Diab & Endo, P.A.
Austin, Texas, United States
Texas Diab & Endo, P.A.
Austin, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
NE Clin Res of San Antonio
San Antonio, Texas, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Univ.-Klinik für Innere Medizin
Graz, , Austria
Univ.-Klinik für Innere Medizin I
Innsbruck, , Austria
Fließer-Görzer [Ordination]
Saint Stefan, , Austria
Policlinico Mater Domini Università di Catanzaro
Catanzaro, , Italy
Azienda Ospedaliero Universitaria Careggi MASTER
Florence, , Italy
Osp. San Raffaele Diabetes Research Institute, Dibit 1
Milan, , Italy
Policlinico Umberto I Clinica Medica DH Diabetologia
Roma, , Italy
Master Centre for Italy
Rome, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
Rome, , Italy
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Japan, Japan
Manda Memorial Hospital_Internal Medicine
Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan
Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, Japan
The Institute of Medical Science, Asahi Life Foundation_Internal Medicine
Chuo-ku, Tokyo, , Japan
H.E.C Science Clinic
Kanagawa, , Japan
Yuri Ono Clinic
Sapporo-shi, Hokkaido, , Japan
Tokyo Women's Medical University_Metabolism and Diabetology
Tokyo, , Japan
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
Bethesda Diabetes Research Center en Bethesda ziekenhuis
Hoogeveen, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Volosevich First City Clinical Hospital
Arkhangelsk, , Russia
LLC "Clinic of new technologies in Medicine"
Dzerzhinskiy, , Russia
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
Moscow, , Russia
Endocrinological Dispensary of Department of healthcare ser.
Moscow, , Russia
Endocrinology Dpt,Post-Graduate Medical Education Faculty
Moscow, , Russia
SPb SBHI "Snegirev Maternity Hospital No. 6"
Saint Petersburg, , Russia
City Consultative & Diagnostic Centre #1
Saint Petersburg, , Russia
SPb SBHI City Multifield Hospital #2
Saint Petersburg, , Russia
SPb SBHI City polyclinic #117
Saint Petersburg, , Russia
LLC "Endocrinolog"
Samara, , Russia
SHI Saratov City Clinical Hospital #9
Saratov, , Russia
Saratov regional clinical hospital
Saratov, , Russia
Voronezh Regional Clinical Consultive-diagnostic Centre
Voronezh, , Russia
Yaroslavl Regional Hospital
Yaroslavl, , Russia
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Clinico Virgen de la Victoria
Málaga, , Spain
Hospital Univ. Central de Asturias
Oviedo, , Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, , Spain
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Endokrinoloji
Adana, , Turkey (Türkiye)
Aydın Adnan Menderes Üniversitesi Hastanesi
Aydin, , Turkey (Türkiye)
Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji
Istanbul, , Turkey (Türkiye)
Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi- Endokrinoloji
Istanbul, , Turkey (Türkiye)
Haydarpaşa Numune Eğitim ve Araştırma Hastanesi - Endokrinoloji
Istanbul, , Turkey (Türkiye)
Erciyes Üniversitesi Hastanesi- Nefroloji
Kayseri, , Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi - Kardiyoloji
Malatya, , Turkey (Türkiye)
Southmead Hospital
Bristol, , United Kingdom
Addenbrooke's Hospital_Cambridge
Cambridge, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Surrey County Hospital - Diabetes
Guildford, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Lister Hospital
Stevenage, , United Kingdom
Joint Clinical Research Facility - Swansea
Swansea, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1251-7315
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002374-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1436-4625
Identifier Type: -
Identifier Source: org_study_id
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