A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin
NCT ID: NCT04770532
Last Updated: 2025-12-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
526 participants
INTERVENTIONAL
2021-03-05
2022-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 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 8 months. Participants will have 17 clinic visits and 13 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 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 their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study.
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)
NCT04795531
A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before
NCT04460885
A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before
NCT04760626
A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes
NCT06340854
A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
NCT07076199
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Insulin icodec
Insulin icodec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.
Insulin Icodec
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks
Insulin degludec
Insulin degludec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.
Insulin degludec
Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily for 26 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Insulin degludec
Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily for 26 weeks
Insulin Icodec
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed with T2D greater than or equal to 180 days prior to the day of screening.
* HbA1c from 7.0-10.0% (53.0 85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
* Treated with once daily or twice daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL): greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to screening:
* Metformin
* Sulfonylureas
* Meglitinides (glinides)
* DPP-4 inhibitors
* SGLT2 inhibitors
* Thiazolidinediones
* Alpha-glucosidase inhibitors
* Oral combination products (for the allowed individual oral anti-diabetic drugs)
* Oral or injectable GLP-1-receptor agonists
* Body mass index (BMI) below or equal to 40.0 kg/m\^2.
Exclusion Criteria
* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
* Chronic heart failure classified as being in New York Heart Association 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
American Clinical Trials
Buena Park, California, United States
Cedars-Sinai Medical Group
Encino, California, United States
Valley Research
Fresno, California, United States
Diabetes/Lipid Mgmt & Res Ctr
Huntington Beach, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Clinical Trials Research_Sacramento
Lincoln, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
South Broward Research LLC
Miramar, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Endo Res Solutions Inc
Roswell, Georgia, United States
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, United States
Four Rivers Clinical Research Inc
Paducah, Kentucky, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
Ileana J Tandron APMC
Slidell, Louisiana, United States
Endo And Metab Cons
Rockville, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
MassResearch, LLC
Waltham, Massachusetts, United States
Palm Research Center Inc.
Las Vegas, Nevada, United States
AMC Community Endocrinology
Albany, New York, United States
Northport VA Med Ctr Northport
Northport, New York, United States
Mountain Diabetes & Endocrine Center
Asheville, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Amarillo Med Spec LLP
Amarillo, Texas, United States
Osvaldo A. Brusco MD PA
Corpus Christi, Texas, United States
Thyroid, Endocrinology, and Diabetes, PA
Dallas, Texas, United States
Baylr Sctt White Rs Inst, Endo
Dallas, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
Diabetes and Thyroid Ctr of FW
Fort Worth, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Hillcrest Family Health Center
Waco, Texas, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, United States
Medical center Medi City 21 OOD
Kyustendil, , Bulgaria
MHAT Med Line Clinic
Plovdiv, , Bulgaria
OCIPSOMCEMD ENDO MED-CONSULT - Dr. Nikolay Botushanov
Plovdiv, , Bulgaria
ASOMCEM - Individual Practice - Dr. Antoanela Slavcheva
Rousse, , Bulgaria
MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases
Sofia, , Bulgaria
UMHAT Sofiamed EAD
Sofia, , Bulgaria
InnoDiab Forschung GmbH
Essen, , Germany
Wendisch/Dahl Hamburg (DZHW)
Hamburg, , Germany
Milek, Hohenmölsen
Hohenmölsen, , Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, , Germany
Praxis Dr. med. Wenzl-Bauer
Rehlingen-Siersburg, , Germany
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, , Germany
VvP Kliniken gGmbH Marienhospital Stuttgart - Innere Medizin I
Stuttgart, , Germany
MZM Praxis Drs. Erlinger
Stuttgart, , Germany
Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
Chigasaki-shi, Kanagawa, Japan, Japan
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, Japan
Tokuyama clinic_Diabetic internal medicine
Chiba, , Japan
Futata Tetsuhiro Clinic Meinohama_Internal medicine
Fukuoka-shi, Fukuoka, , Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, , Japan
Yuri Ono Clinic
Sapporo-shi, Hokkaido, , Japan
Oyama East Clinic_Internal Medicine
Tochigi, , Japan
Juntendo University Hospital_Tokyo
Tokyo, , Japan
Noritake Clinic
Ushiku-shi, Ibaraki, , Japan
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, , Poland
NZOZ "DiabMed" Poradnia Diabetologiczna
Poznan, , Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, , Poland
Unidade Local De Saude De Matosinhos E.P.E.
Senhora Da Hora, Matosinhos, Matosinhos, Portugal
Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta
Almada, , Portugal
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, , Portugal
Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon, , Portugal
Unidade Local de Saúde de Santo António, E.P.E
Porto, , Portugal
Unidade Local de Saude de Sao Joao E.P.E
Porto, , Portugal
Hospital Luz Arrabida, S.A.
Vila Nova de Gaia, , Portugal
Greenacres Hospital
Port Elizabeth, Eastern Cape, South Africa
Medi-Clinic Bloemfontein
Bloemfontein, Free State, South Africa
Hemant Makan
Johannesburg, Gauteng, South Africa
Chris Hani Baragwanath Hospital
Johannesburg, Gauteng, South Africa
Centre for Diabetes
Johannesburg, Gauteng, South Africa
Dr A Amod
Durban, KwaZulu-Natal, South Africa
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, , South Korea
"University Clinic" of Dnipro State Medical University - Endocrinology department
Dnipro, , Ukraine
Department of Medical Service and Rehabilitation of "ARTEM" - day hospital department
Kyiv, , Ukraine
Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
Kyiv, , Ukraine
Ternopil Central District Hospital - Outpatient department
Ternopil, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Philis-Tsimikas A, Asong M, Franek E, Jia T, Rosenstock J, Stachlewska K, Watada H, Kellerer M. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 Jun;11(6):414-425. doi: 10.1016/S2213-8587(23)00093-1. Epub 2023 May 3.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1247-4945
Identifier Type: OTHER
Identifier Source: secondary_id
2020-000454-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1436-4478
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.