AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3ONWARDS 4NCT04880850

A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)

A Phase 3 study testing Insulin icodec, Insulin glargine and Insulin aspart in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 116 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin icodec, Insulin glargine and Insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
582 participants
Where
116 sitesin 9 countries
Study dates
14 May 2021to 16 Jun 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female aged above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus (T2D) greater than or equal to 180 days prior to the day of screening.
  • Glycated haemoglobin (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 basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, insulin glulisine) 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.

Who cannot join

  • 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.

Trial locations and contacts

116 sites in 9 countries.

116 sites in 9 countries

United States52 sites

  • AMC Community Endocrinology

    Albany, New York, 12206

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Mountain Diabetes & Endocrine Center

    Asheville, North Carolina, 28803

  • Texas Diab & Endo, P.A.

    Austin, Texas, 78731

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78749

  • AM Diabetes And Endocrinology Center

    Bartlett, Tennessee, 38133

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • John Muir Physicians Network

    Concord, California, 94520

  • Osvaldo A. Brusco MD PA

    Corpus Christi, Texas, 78414

  • Baylr Sctt White Rs Inst, Endo

    Dallas, Texas, 75226

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Protenium Clinical Research_Hurst

    Fort Worth, Texas, 76113

  • Valley Research

    Fresno, California, 93720

  • Physician's East Endocrinology

    Greenville, North Carolina, 27834

  • Prisma Health-Upstate

    Greenville, South Carolina, 29605-4254

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • Diabetes/Lipid Mgmt & Res Ctr

    Huntington Beach, California, 92648

  • Indiana-Armstrong Endocrinology Associates

    Indiana, Pennsylvania, 15701

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida, 32216

  • Jefferson City Medical Group, PC

    Jefferson City, Missouri, 65109

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148

  • Physicians Research Assoc. LLC

    Lawrenceville, Georgia, 30046

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605

  • Your Diabetes Endocrine Nutrition Group, Inc.

    Mentor, Ohio, 44060

  • Saltzer Medical Group Research

    Nampa, Idaho, 83686-6011

  • Vanderbilt Diab Obes Clin Tri

    Nashville, Tennessee, 37212

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Northport VA Medical Center_Northport_0

    Northport, New York, 11768

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • VA NEB - Western IA Health Stm

    Omaha, Nebraska, 68105

  • Methodist Physicians Clin

    Omaha, Nebraska, 68114

  • Clinical Trial Res Assoc,Inc

    Plantation, Florida, 33324

  • Oregon Health & Science University_Portland_0

    Portland, Oregon, 97239

  • Clinical Trials Research_Sacramento_0

    Sacramento, California, 95821

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Diabetes Research Center

    Tustin, California, 92780

  • Velocity Clin. Res Valparaiso

    Valparaiso, Indiana, 46383

  • Coastal Metabolic Research Center

    Ventura, California, 93003

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • MassResearch, LLC

    Waltham, Massachusetts, 02453

  • MedStar Diabetes Institute

    Washington D.C., District of Columbia, 20010

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

Other trials in United States

India17 sites

  • St.John's Hospital

    Bangalore, Karnataka, 560034

  • Bangalore Clinisearch

    Bangalore, Karnataka, 560043

  • Lifecare Hospital and Research Centre

    Bangalore, Karnataka, 560092

  • Belgaum Diabetes Centre

    Belagavi, Karnataka, 590001

  • Manipal Hospital, Hebbal, Bengaluru

    Bengaluru, Karnataka, 560 024

  • S.C.B. Medical College

    Cuttack, Odisha, 753007

  • Maulana Azad Medical College

    Delhi, New Delhi, 110002

  • Medanta - The Medicity Multi-Speciality Hospital, Gurugram

    Gurgaon, Haryana, 122001

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006

  • Renai Medicity

    Kochi, Kerala, 682025

  • Kurnool Medical Collage

    Kurnool, Andhra Pradesh, 518002

  • Prince Aly Khan Hospital

    Mumbai, Maharashtra, 400010

  • BSES MG hospital

    Mumbai, Maharashtra, 400058

  • All India Institute of Medical Sciences

    New Dehli, New Delhi, 110029

  • Max Super Speciality Hospital, Saket

    New Delhi, National Capital Territory of Delhi, 110017

  • Fortis Hospital, Shalimar Bagh, New Delhi

    New Delhi, National Capital Territory of Delhi, 110088

  • Grant Medical Foundation

    Pune, Maharashtra, 411001

Other trials in India

Russia11 sites

  • Arkhangelsk Regional Clinical Hospital

    Arkhangelsk, 163045

  • City Hospital #5

    Barnaul, 656045

  • KSFMU, Inrereginal Clinical Diagnostic center

    Kazan', 420010

  • Kirov Clinical Hospital #7

    Kirov, 610014

  • Limited Liability Company "AriVa-Med"

    Kursk, 305016

  • City Clinical Hospital №52

    Moscow, 123182

  • LLC "Centr Targetnoy Terapii"

    Moscow, 125008

  • Limited Law Company "Healthy Family" Medicine Center"

    Novosibirsk, 630099

  • SPb SBHI City Outpatient clinic #37

    Saint Petersburg, 191119

  • Regional clinical cardiology dispensary

    Saratov, 410039

  • Tumen State Medical University

    Tyumen, Russia, 625023

Other trials in Russia

Japan9 sites

  • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine

    Chigasaki-shi, Kanagawa, Japan, 253-0044

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006

  • Sasaki Internal Medicine

    Hokkaido, 062-0007

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

  • Sugimoto Clinic,Internal Medicine

    Kitakyusyu-shi, Fukuoka, 800-0222

  • Shimizu Clinic Fusa

    Saitama, 336-0967

  • Oyama East Clinic_Internal Medicine

    Tochigi, 323-0022

  • The Jikei University Hospital Dept of Diabetes, Metabolic

    Tokyo, 105-8471

  • Noritake Clinic

    Ushiku-shi, Ibaraki, 300-1207

Other trials in Japan

Netherlands7 sites

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn, 7334 DZ

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD

  • Maxima Medisch Centrum

    Eindhoven, 5631 BM

  • Bethesda Diabetes Research Center en Bethesda ziekenhuis

    Hoogeveen, 7909 AA

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Italy6 sites

  • A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura

    Bologna, 40138

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, Cz, 88100

  • Università degli Studi G. D'Annunzio

    Chieti, 66100

  • Istituto Scientifico San Raffaele

    Milan, MI, 20132

  • A.O.U. Università Studi della Campania "Luigi Vanvitelli"

    Naples, Campania, 80138

  • Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale

    Roma, 00161

Other trials in Italy

Romania6 sites

  • Mariodiab Clinic SRL

    Brasov, 500101

  • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

    Bucharest, Bucurestii, 020475

  • S.C. Medcon S.R.L

    Buzău, 120203

  • Clinical Emergency Sf. Apostol Andrei Hospital

    Galati, 800578

  • Spitalul Judetean de Urgenta Targoviste

    Targoviste, Dâmbovița County, 130083

  • Sc Mediab Srl

    Târgu Mureş, Mureș County, 540142

Other trials in Romania

Belgium5 sites

  • Imeldaziekenhuis - Bonheiden - Department of Endocrinology

    Bonheiden, 2820

  • CHU Helora - Site Warquignies

    Boussu, 7300

  • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

    Brussels, 1200

  • UZA - UZ Antwerpen - Department of Endocrinology

    Edegem, 2650

  • UZ Leuven - Endocrinology

    Leuven, 3000

Other trials in Belgium

Mexico3 sites

  • Hospital Universitario Dr. José Eleuterio González_Monterrey

    Monterrey, Nuevo León, 64460

  • Unidad Biomedica Avanzada Monterrey

    Monterrey, Nuevo León, 64460

  • Centro de Investigacion Medica de Occidente S.C.

    Zapopan, Jalisco, 45116

Other trials in Mexico

About this study

Official title: A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen

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.

Read more

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 will get is decided by chance. 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 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.

Being tested
Insulin icodec, Insulin glargine, Insulin aspart
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin icodecDrug

    Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks

  • Insulin glargineDrug

    Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 26 weeks

  • Insulin aspartDrug

    Participants will receive subcutaneous (s.c.) injections of insulin aspart 2-4 times daily for 26 weeks

Study groups in NCT04880850
Study groupRoleWhat they receive
insulin icodec + insulin aspartExperimentalParticipants will get once weekly injections in combination with 2-4 times daily injections of insulin aspart
Receives: Drug: Insulin icodec; Drug: Insulin aspart
Insulin glargine + insulin aspartActive comparatorParticipants will get once daily injections in combination with 2-4 times daily injections of insulin aspart
Receives: Drug: Insulin glargine; Drug: Insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (week 0), Week 26

Secondary outcomes (9)

  1. 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.

    Measured: Baseline (week 0), Week 26

  2. 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 milligrams per deciliter [mg/dL]) using continuous glucose monitoring (CGM) system from week 22 to week 26 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.

    Measured: From week 22 to week 26

  3. Number of Severe Hypoglycaemic Episodes (Level 3)

    Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the on-treatment observation period. The on-treatment observation 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, 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.

    Measured: From baseline (week 0) to week 31

  4. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL) Confirmed by Blood Glucose (BG) Meter)

    Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). The outcome data was evaluated based on the on-treatment observation period. The on-treatment observation 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, 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.

    Measured: From baseline (week 0) to week 31

  5. 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)

    Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the in-trial observation period. The on-treatment observation 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, 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.

    Measured: From baseline (week 0) to week 31

  6. Percentage of Time Spent Below 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System

    Percentage of time spent less than (<) 3.0 mmol/L (54 mg/dL) using CGM system from week 22 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.

    Measured: From week 22 to week 26

  7. Percentage of Time Spent Above 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System

    Percentage of time spent > 10 mmol/L (180 mg/dL) using CGM system from week 22 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.

    Measured: From week 22 to week 26

  8. 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 observation 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, 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.

    Measured: From week 24 to week 26

  9. 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.

    Measured: Baseline (week 0), Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start14 May 2021
  3. Primary completion16 Jun 2022
  4. Study completion16 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
582 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04880850
Sponsor's protocol ID
NN1436-4480
Other IDs
U1111-1247-5269, 2020-000474-16
Acronym
ONWARDS 4
Status last verified
Nov 2025
First submitted
6 May 2021
Last updated
4 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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.

    PubMed 36106652

  • Mathieu C, Asbjornsdottir B, Bajaj HS, Lane W, Matos ALSA, Murthy S, Stachlewska K, Rosenstock J. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet. 2023 Jun 10;401(10392):1929-1940. doi: 10.1016/S0140-6736(23)00520-2. Epub 2023 May 5.

    PubMed 37156252

  • Kristensen NR, Haridas MP, Philis-Tsimikas A, Ribel-Madsen R, Mathieu C. The Effect of Intrinsic Factors on the Pharmacokinetics of Once-Weekly Insulin Icodec in Type 1 and Type 2 Diabetes: A Population Pharmacokinetic Analysis of Phase II and Phase III trials. Clin Pharmacokinet. 2026 Sep 30. doi: 10.1007/s40262-026-01710-9. Online ahead of print.

    PubMed 42814374

  • 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.

    PubMed 41051694

  • 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.

    PubMed 40465144

  • 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.

    PubMed 40186685

  • 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.

    PubMed 39344833

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin icodec, Insulin glargine and Insulin aspart in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 116 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, India, Russia, Japan, Netherlands and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (week 0), Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04880850, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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ONWARDS 4 Clinical Trial NCT04880850 | AzTrials