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 (ONWARDS 2)

A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec, Both With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes Treated With Basal Insulin

This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (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 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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Icodec; Drug: Insulin degludec

• Study Type: Interventional
• Enrollment (Actual): 526
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Kyustendil, Bulgaria, 2500
    • Medical center Medi City 21 OOD
  • Plovdiv, Bulgaria, 4002
    • OCIPSOMCEMD ENDO MED-CONSULT - Dr. Nikolay Botushanov
  • Plovdiv, Bulgaria, 4000
    • MHAT Med Line Clinic
  • Rousse, Bulgaria, 7002
    • ASOMCEM - Individual Practice - Dr. Antoanela Slavcheva
  • Sofia, Bulgaria, 1606
    • MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases
  • Sofia, Bulgaria, 1797
    • UMHAT Sofiamed EAD
• Germany
  • Essen, Germany, 45136
    • InnoDiab Forschung GmbH
  • Hamburg, Germany, 22607
    • Wendisch/Dahl Hamburg (DZHW)
  • Hohenmölsen, Germany, 06679
    • Milek, Hohenmölsen
  • Münster, Germany, 48145
    • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
  • Rehlingen-Siersburg, Germany, 66780
    • Praxis Dr. med. Wenzl-Bauer
  • Saint Ingbert-Oberwürzbach, Germany, 66386
    • Zentrum für klinische Studien Alexander Segner
  • Stuttgart, Germany, 70378
    • MZM Praxis Drs. Erlinger
  • Stuttgart, Germany, 70199
    • VvP Kliniken gGmbH Marienhospital Stuttgart - Innere Medizin I
• Japan
  • Chiba, Japan, 261-0004
    • Tokuyama clinic_Diabetic internal medicine
  • Fukuoka-shi, Fukuoka, Japan, 819-0006
    • Futata Tetsuhiro Clinic Meinohama_Internal medicine
  • Ibaraki, Japan, 311-0113
    • Naka Kinen Clinic_Internal medicine
  • Sapporo-shi, Hokkaido, Japan, 060-0001
    • Yuri Ono Clinic
  • Tochigi, Japan, 323-0022
    • Oyama East Clinic_Internal Medicine
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital_Tokyo
  • Ushiku-shi, Ibaraki, Japan, 300-1207
    • Noritake Clinic
  • Kanagawa, Japan
    • Chigasaki-shi, Kanagawa, Japan, Japan, 253-0044
      • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
  • Miyazaki
    • Miyazaki, Miyazaki, Japan, 880-0034
      • Heiwadai Hospital_Internal Medicine
• Poland
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
  • Poznan, Poland, 60-821
    • NZOZ "DiabMed" Poradnia Diabetologiczna
  • Warsaw, Poland, 02-507
    • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
• Portugal
  • Almada, Portugal, 2805-267
    • Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta
  • Coimbra, Portugal, 3000-561
    • Unidade Local de Saúde de Coimbra, E.P.E.
  • Lisbon, Portugal, 1349-019
    • Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
  • Porto, Portugal, 4099-001
    • Unidade Local de Saúde de Santo António, E.P.E
  • Porto, Portugal, 4200-319
    • Unidade Local de Saude de Sao Joao E.P.E
  • Vila Nova de Gaia, Portugal, 4400-346
    • Hospital Luz Arrabida, S.A.
  • Matosinhos
    • Senhora Da Hora, Matosinhos, Matosinhos, Portugal, 4464-513
      • Unidade Local De Saude De Matosinhos E.P.E.
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6045
      • Greenacres Hospital
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Medi-Clinic Bloemfontein
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1827
      • Hemant Makan
    • Johannesburg, Gauteng, South Africa, 2198
      • Centre for Diabetes
    • Johannesburg, Gauteng, South Africa, 2013
      • Chris Hani Baragwanath Hospital
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4092
      • Dr A Amod
• South Korea
  • Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 139-827
    • Nowon Eulji Medical Center, Eulji University
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16247
      • The Catholic University of Korea, St. Vincent'S Hospital
• Ukraine
  • Dnipro, Ukraine, 49038
    • "University Clinic" of Dnipro State Medical University - Endocrinology department
  • Kyiv, Ukraine, 04114
    • Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
  • Kyiv, Ukraine, 04053
    • Department of Medical Service and Rehabilitation of "ARTEM" - day hospital department
  • Ternopil, Ukraine, 46001
    • Ternopil Central District Hospital - Outpatient department
• United States
  • California
    • Buena Park, California, United States, 90620
      • American Clinical Trials
    • Encino, California, United States, 91436
      • Cedars-Sinai Medical Group
    • Fresno, California, United States, 93720
      • Valley Research
    • Huntington Beach, California, United States, 92648
      • Diabetes/Lipid Mgmt & Res Ctr
    • La Jolla, California, United States, 92037
      • Scripps Whittier Diabetes Inst
    • Lincoln, California, United States, 95648
      • Clinical Trials Research_Sacramento
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Palm Springs, California, United States, 92262
      • Desert Oasis Hlthcr Med Group
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Miramar, Florida, United States, 33027
      • South Broward Research LLC
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Roswell, Georgia, United States, 30076
      • Endo Res Solutions Inc
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clin. Res Valparaiso
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Four Rivers Clinical Research Inc
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • New Orleans Center for Clinical Research
    • Slidell, Louisiana, United States, 70461-4231
      • Ileana J Tandron APMC
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Endo And Metab Cons
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-5804
      • Brigham & Women's Hospital
    • Waltham, Massachusetts, United States, 02453
      • MassResearch, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center Inc.
  • New York
    • Albany, New York, United States, 12203
      • AMC Community Endocrinology
    • Northport, New York, United States, 11768
      • Northport VA Med Ctr Northport
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Mountain Diabetes & Endocrine Center
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest Life Sciences LLC
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Med Spec LLP
    • Corpus Christi, Texas, United States, 78414
      • Osvaldo A. Brusco MD PA
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Res-Dallas
    • Dallas, Texas, United States, 75390-9302
      • UT Southwestern Med Cntr
    • Dallas, Texas, United States, 75208
      • Thyroid, Endocrinology, and Diabetes, PA
    • Dallas, Texas, United States, 75226
      • Baylr Sctt White Rs Inst, Endo
    • Fort Worth, Texas, United States, 76132
      • Diabetes and Thyroid Ctr of FW
    • Houston, Texas, United States, 77079
      • PlanIt Research, PLLC
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • Sugar Land, Texas, United States, 77478
      • Simcare Medical Research, LLC
    • Waco, Texas, United States, 76708
      • Hillcrest Family Health Center
  • Washington
    • Olympia, Washington, United States, 98502
      • Capital Clin Res Ctr,LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female aged above or equal to 18 years at the time of signing informed consent.
• 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:

• Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Insulin Icodec; Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks
Active Comparator: 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.	Drug: Insulin degludec; Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Haemoglobin (HbA1c)	Change in HbA1c from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation 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) and death for participants who died before any of the above.	Baseline (Week 0), Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Plasma Glucose (FPG)	Change in FPG from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation 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) and death for participants who died before any of the above.	Baseline (Week 0), Week 26
Percentage of Time in Target-range 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System	The percentage of time in target-range 3.9-10.0 mmol/L (70-180 milligrams per deciliter [mg/dL]) using continuous glucose monitoring (CGM) system 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. 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) and death for participants who died before any of the above.	From week 22 to week 26
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction	Change in DTSQs in total treatment satisfaction from baseline (week 0) to week 26 is presented. The DTSQ domain score in total treatment satisfaction was calculated by adding the six item scores of items 1, 4-8. Higher scores indicate higher levels of treatment satisfaction for items 1, 4 -8. For items 2 and 3 a higher score indicates a participant perceived experience of hyperglycaemia and hypoglycaemia. Lower scores indicate a perception of blood glucose levels being unacceptably high (item 2) or low (item 3). The score has a minimum of 0 and a maximum of 36. The outcome data was evaluated based on in-trial observation period. In-trial observation period started at randomisation and ended at the date of: Last direct participant-site contact, withdrawal for participants who withdrew their informed consent, last participant-investigator contact as defined by the investigator for participants who were lost to follow-up and death for participants who died before any of the above.	Baseline (Week 0), Week 26
Number of Severe Hypoglycaemic Episodes (Level 3)	Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the on-treatment observation period. The 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 of trial visit (V30), 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 participant was considered exposed to trial product.	From baseline (week 0) to week 31
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)	Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) is 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. The outcome data was evaluated based on the on-treatment observation period. The 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 of trial visit (V30), 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 participant was considered exposed to trial product.	From baseline (week 0) to week 31
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)	Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of < 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. The outcome data was evaluated based on the in-trial observation period. The 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 of trial visit (V30), 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.	From baseline (week 0) to week 31
Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System	Percentage of tiime spent < 3.0 millimoles per liter (mmol/L) (54 mg/dL) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation 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) and death for participants who died before any of the above.	From week 22 to week 26
Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System	Percentage of time spent > 10 millimoles per liter (mmol/L) (180 milligrams per deciliter [mg/dL]) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation 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) and death for participants who died before any of the above.	From week 22 to week 26
Mean Weekly Insulin Dose	Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The outcome data was evaluated based on the on-treatment observation period. The 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 of trial visit (V30), 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 participant was considered exposed to trial product.	From week 24 to week 26
Change in Body Weight	Change in body weight from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation 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) and death for participants who died before any of the above.	Baseline (Week 0), Week 26

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): January 27, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Hypoglycemic Agents; insulin icodec; insulin degludec
• Other Study ID Numbers: NN1436-4478; U1111-1247-4945 (Other Identifier: World Health Organization (WHO)); 2020-000454-10 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No