AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3ONWARDS 3NCT04795531

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)

A Phase 3 study testing Insulin icodec and Insulin degludec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 190 sites in 12 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin icodec and Insulin degludec
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
588 participants
Where
190 sitesin 12 countries
Study dates
24 Mar 2021to 23 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 18 years and older
  • All sexes
  • No healthy volunteers
  • 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 T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening.
  • HbA1c (glycated haemoglobin) from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
  • Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
  • Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s):
  • a.) Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b.) Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c.) Any of the following oral anti-diabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose).:Sulfonylureas - Meglitinides (glinides) - DPP-4 inhibitors - SGLT2 inhibitors - Thiazolidinediones - Alpha-glucosidase inhibitors - Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs)) - 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 (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.

Trial locations and contacts

190 sites in 12 countries.

190 sites in 12 countries

United States94 sites

  • Albuquerque Clin Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Texas Diab & Endo, P.A.

    Austin, Texas, 78731

  • Advanced Clinical Research/Rancho Paseo Medical Group

    Banning, California, 92220

  • AM Diabetes And Endocrinology Center

    Bartlett, Tennessee, 38133

  • Heritage Valley Multispeciality Group Inc

    Beaver, Pennsylvania, 15009

  • Univ of Alabama Birmingham

    Birmingham, Alabama, 35222

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Wade Family Medicine

    Bountiful, Utah, 84010

  • N.Y. Total Medical Care PC

    Brooklyn, New York, 11215

  • American Clinical Trials

    Buena Park, California, 90620

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718

  • Med Center Medical Clinic

    Carmichael, California, 95608

  • University of North Carolina

    Chapel Hill, North Carolina, 27517

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Diabetes & Endo Specialists Inc

    Chesterfield, Missouri, 63017

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • St Elizabeth Physicians Heart

    Covington, Kentucky, 41011

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • Spectrum Medical, Inc

    Danville, Virginia, 24541

  • Providence Health Partners Ctr

    Dayton, Ohio, 45439

  • Revival Research

    Doral, Florida, 33122

  • Denver Endocrinology Diabetes and Thyroid Center

    Englewood, Colorado, 80113

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Plains Clinical Research Center, LLC

    Fargo, North Dakota, 58104

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Valley Research

    Fresno, California, 93720

  • Northwell Health Div of Endo

    Great Neck, New York, 11021

  • Physician's East Endocrinology

    Greenville, North Carolina, 27834

  • Lakeview Clinical Research, LLC

    Guntersville, Alabama, 35976

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • PrimeCare Medical Group

    Houston, Texas, 77024

  • JCCT- Juno NW Houston

    Houston, Texas, 77040

  • MedStar Community Clin Res Ctr

    Hyattsville, Maryland, 20782

  • Est Cst Inst for Rsrch,Jksnvil

    Jacksonville, Florida, 32216

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida, 32216

  • Clinical Investigation Specialists Inc, Kenosha

    Kenosha, Wisconsin, 53144

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

  • Fmc Science, Llc

    Lampasas, Texas, 76550

  • First Valley Medical Group

    Lancaster, California, 93534

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148

  • Physicians Research Assoc. LLC

    Lawrenceville, Georgia, 30046

  • Clinical Trials Research_Sacramento

    Lincoln, California, 95648

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • Torrance Clin Res Inst, Inc.

    Lomita, California, 90717

  • Your Diabetes Endocrine Nutrition Group, Inc.

    Mentor, Ohio, 44060

  • University Of Miami

    Miami, Florida, 33136

  • The Diabetes Center, LLC

    Murrells Inlet, South Carolina, 29576

  • Southern New Hampshire Diabete

    Nashua, New Hampshire, 03060

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • NYU Grossman School of Med

    New York, New York, 10016

  • TPMG Clinical Research

    Newport News, Virginia, 23606

  • Intend Research

    Norman, Oklahoma, 73069

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Methodist Physicians Clin

    Omaha, Nebraska, 68114

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198-3020

  • Florida Institute for Clinical research

    Orlando, Florida, 32825

  • Four Rivers Clinical Research Inc

    Paducah, Kentucky, 42001

  • Palm Harbor Medical Associates

    Palm Harbor, Florida, 34684-3609

  • Suncoast Clinical Research, Inc.

    Palm Harbor, Florida, 34684

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262

  • Clinical Research Source Inc

    Perrysburg, Ohio, 43551

  • Daniel G Williams MD

    Perrysburg, Ohio, 43551

  • Oregon Health & Science University_Portland_0

    Portland, Oregon, 97239

  • Medication Management, LLC

    Raleigh, North Carolina, 27609

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Endo and Metab Consultants

    Rockville, Maryland, 20852

  • Texas Diab & Endo, P.A.

    Round Rock, Texas, 78681

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • NE Clin Res of San Antonio

    San Antonio, Texas, 78233

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538

  • Endocrine Associates of Long Island, PC

    Smithtown, New York, 11787

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • RNA America Health Sciences

    Sugar Hill, Georgia, 30518

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478

  • Elite Medical Care

    Sugar Land, Texas, 77479

  • Cotton-Oneill Diabetes and End

    Topeka, Kansas, 66606-2806

  • Arcturus HC PLC Troy Med Res

    Troy, Michigan, 48098

  • Diabetes Research Center

    Tustin, California, 92780

  • Coastal Metabolic Research Center

    Ventura, California, 93003

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

  • Accellacare

    Wilmington, North Carolina, 28401

  • Ardmore Family Practice

    Winston-Salem, North Carolina, 27103

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157

  • Clinical Research of Cent FL

    Winter Haven, Florida, 33880

Other trials in United States

Canada32 sites

  • LMC Diabetes & Endocrinology (Barrie)

    Barrie, Ontario, L4N 7L3

  • LMC ClinRsrh Inc.Brampton

    Brampton, Ontario, L6S 0C6

  • ViaCar Recherche Clinique Inc

    Brossard, Quebec, J4Z 2K9

  • LMC Clin Res Inc. Calgary

    Calgary, Alberta, T2H 2G4

  • Saul Vizel Pro. Med. Corp

    Cambridge, Ontario, N1R 7R1

  • LMC Clinical Res Thornhill

    Concord, Ontario, L4K 4M2

  • LMC Endo Ctr (Etobicoke) Ltd

    Etobicoke, Ontario, M9R 4E1

  • Janik Research

    Greater Sudbury, Ontario, P3B 4H5

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8M 1K7

  • St. Joseph's Hospital

    London, Ontario, N6A 4V2

  • Western Univ. Cnt for Studies in Fam Med

    London, Ontario, N6G 2M1

  • Clinique de Recherche Medpharmgene Inc.

    Montreal, Quebec, H1Y 3L1

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2

  • Commonwealth Medical Clinic

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • LMC Research Inc. Ottawa

    Nepean, Ontario, K2J 0V2

  • Manna Research Ottawa

    Nepean, Ontario, K2J 4A7

  • LMC Oakville

    Oakville, Ontario, L6M 1M1

  • Dr. James Cha

    Oshawa, Ontario, L1J 2K1

  • Recherche Clinique Sigma inc

    Québec, G1G 5X1

  • Centre Hospitalier de l'Université Laval

    Québec, G1V 4G2

  • The Bailey Clinic

    Red Deer, Alberta, T4N 6V7

  • LMC Clin Rsrch Inc. (Montreal)

    Saint-Laurent, Quebec, H4T 1Z9

  • Bluewater Clin Res Group,Inc

    Sarnia, Ontario, N7T 4X3

  • Q & T Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1J 2G2

  • Eastern Health Authority

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 0K2

  • Centricity Research LMC (Toronto)

    Toronto, Ontario, M4G 3E8

  • Dr Anil K Gupta Med Prof Corp

    Toronto, Ontario, M9V 4B4

  • BC Diabetes Canada

    Vancouver, British Columbia, V5Y 3W2

  • Dr. Ehud Ur

    Vancouver, British Columbia, V6H 3X8

  • Diex Recherche Victoriaville

    Victoriaville, Quebec, G6P 6P6

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

China18 sites

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing, Beijing Municipality, 100853

  • Beijing Pinggu Hospital-Endocrinology

    Beijing, Beijing Municipality, 101200

  • Beijing Pinggu Hospital

    Beijing, Beijing Municipality, 101200

  • Cangzhou People's Hospital-Endocrinology

    Cangzhou, Hebei, 061000

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • Changzhou No.2 People's Hospital, Yanghu Branch

    Changzhou, Jiangsu, 213003

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

  • The First Affiliated Hospital of Anhui Medical University-Endocrinology

    Hefei, Anhui, 230061

  • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

    Hengshui, Hebei, 053000

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu, 210011

  • Nanjing Jiangning Hospital-Endocrinology

    Nanjing, Jiangsu, 211199

  • Shanghai Tenth People's Hospital (Tenth People's of Tongji University)-Endocrinology

    Shanghai, Shanghai Municipality, 200072

  • Shanghai Fifth People's Hospital-Endocrinology

    Shanghai, Shanghai Municipality, 200240

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University General Hospital-Endocrinology

    Tianjin, Tianjin Municipality, 300052

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu, 212001

Other trials in China

France10 sites

  • Les Hopitaux de Chartres-Hopital Louis Pasteur

    Le Coudray, 28630

  • Centre Medical Medicina Rockefeller

    Lyon, 69008

  • Centre Hospitalier de Narbonne

    Narbonne, 11100

  • Ap-Hp-Hopital Bichat-Claude Bernard

    Paris, 75877

  • Master centre for France

    Paris La Défense, 92936

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2

    Pessac, 33600

  • Hospices Civils de Lyon-Hopital Lyon Sud

    Pierre-Bénite, 69310

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-3

    Saint-Herblain, 44800

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

    Toulouse, 31054

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200

Other trials in France

Austria7 sites

  • Universitätsklinik für Innere Medizin Graz

    Graz, 8036

  • Universitätsklinik für Innere Medizin

    Graz, 8036

  • Barmh. Brüder Linz, Konventspital

    Linz, 4021

  • Gesundheitszentrum Hetzendorf

    Vienna, 1120

  • Ordination Dr. Günter Sokol

    Vienna, 1120

  • Klinik Hietzing 3. Med. Abt.

    Vienna, 1130

  • Hanusch-Krankenhaus, Wien

    Vienna, 1140

Other trials in Austria

Czechia7 sites

  • Edumed Broumov

    Broumov, 550 01

  • Diahelp - diabetologie

    Pardubice, 530 02

  • DIALINE s.r.o.

    Plzeň 3, 301 00

  • Diabet2 s.r.o.

    Prague, 110 00

  • EUC Klinika Praha a.s.

    Prague, 150 00

  • Fledip s.r.o.

    Prague, 160 00

  • Master Centre for Czech Rep

    Prague, 18600

Other trials in Czechia

Taiwan5 sites

  • Changhua Christian Hospital_Metabolic Dept.

    Changhua, 500

  • Chung Shan Medical University Hospital

    Taichung, 402

  • Taichung Veterans General Hospital

    Taichung, 407

  • Chi Mei Medical Center

    Tainan, 710

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Argentina4 sites

  • STAT Research

    Buenos Aires, C1023AAB

  • CEDIC Centro de Investigación Clínica

    CABA, C1060ABA

  • CENUDIAB Centro Médico de Nutrición v Diabetes

    CABA, C1440AAD

  • Instituto de Clínica Médica y Diabetes

    Mendoza, 5500

Other trials in Argentina

Brazil4 sites

  • Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV

    Curitiba, Paraná, 80045-110

  • Centro de Diabetes Curitiba

    Curitiba, Paraná, 80810-040

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

    Porto Alegre, Rio Grande do Sul, 90430-001

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

Other trials in Brazil

Denmark4 sites

  • Aarhus Universitetshospital Diabetes og Hormonsygdomme

    Aarhus N, 8200

  • Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden

    Esbjerg, 6700

  • Steno Diabetes Center Cph_Steno Diabetes Center Cph

    Hellerup, 2900

  • Hvidovre Hospital Endokrinologisk forsk. afs. 159

    Hvidovre, 2650

Other trials in Denmark

Puerto Rico3 sites

  • Advanced Clinical Research LLC

    Bayamón, 00959

  • Manati Ctr For Clin Research

    Manati, 00674

  • Luis Rivera Colon, M.D., FACDS

    Rio Piedras, 00921

Other trials in Puerto Rico

Mexico2 sites

  • Consultorio Arechavaleta Granell María del Rosario

    Guadalajara, Jalisco, 44650

  • Investigación Médica Sonora S.C.

    Hermosillo, Sonora, 83280

Other trials in Mexico

About this study

Official title: A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.

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.

Read more

Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get.

The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 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.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Being tested
Insulin icodec, Placebo insulin icodec, Insulin degludec, Placebo insulin degludec
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

    You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo.

    Subcutaneously (under the skin) injections

  • Placebo insulin icodecDrug

    You will get a pen for weekly injection and one for daily injection. One will be insulin degludec 100 units/mL and the other will be placebo.

    Subcutaneously (under the skin) injections

  • Insulin degludecDrug

    You will get a pen for weekly injection and one for daily injection. One will be degludec 100 units/mL and the other will be placebo.

    Subcutaneously (under the skin) injections

  • Placebo insulin degludecDrug

    You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo.

    Subcutaneously (under the skin) injections

Study groups in NCT04795531
Study groupRoleWhat they receive
Once weekly insulin icodec + once daily placeboExperimentalParticipants will get once daily and once weekly injections
Receives: Drug: Insulin icodec; Drug: Placebo insulin degludec
Once weekly placebo and once daily insulin degludecExperimentalParticipants will get once daily and once weekly injections
Receives: Drug: Placebo insulin icodec; Drug: Insulin degludec

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 is evaluated based on the in-trial observation period. The in-trial 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. The in-trial 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. 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-tratment 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.

    Measured: From baseline (week 0) to week 31

  3. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (< 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose [BG] Meter)

    Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per liter (mmol/L) (54 mg/dL), confirmed by 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 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.

    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 BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

    Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L) (54 mg/dL), confirmed by blood glucose [BG] meter) or severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment 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.

    Measured: From baseline (week 0) to week 31

  5. 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.

    Measured: From baseline (week 0) to week 26

  6. 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 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.

    Measured: From baseline (week 0) to week 26

  7. 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 BG meter) or severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter [mg/dL]) confirmed by blood glucose (BG) meter.

    Measured: From baseline (week 0) to week 26

  8. 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. The in-trial 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

  9. 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 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.

    Measured: From week 24 to 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 posted12 Mar 2021
  2. Study start24 Mar 2021
  3. Primary completion23 Jun 2022
  4. Study completion23 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
588 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04795531
Sponsor's protocol ID
NN1436-4479
Other IDs
U1111-1247-5218, 2020-000472-37
Acronym
ONWARDS 3
Status last verified
May 2026
First submitted
10 Mar 2021
Last updated
12 Jun 2026
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

  • 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

  • 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

  • Li Y, Kar S, Li C, Liu M, Luan Z, Yuan G, Zhong X, Mu Y. Once-Weekly Insulin Icodec Versus Once-Daily Insulin Degludec in Insulin-Naive Chinese Participants with Type 2 Diabetes: A Post Hoc Analysis of ONWARDS 3. Diabetes Ther. 2025 Apr;16(4):685-699. doi: 10.1007/s13300-025-01701-2. Epub 2025 Feb 28.

    PubMed 40016570

  • Lingvay I, Asong M, Desouza C, Gourdy P, Kar S, Vianna A, Vilsboll T, Vinther S, Mu Y. Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial. JAMA. 2023 Jul 18;330(3):228-237. doi: 10.1001/jama.2023.11313.

    PubMed 37354562

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin icodec and Insulin degludec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 190 sites in 12 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 7 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 190 sites in United States, Canada, China, France, Austria and 7 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 4 Dec 2024). 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 NCT04795531, which also lists 6 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 12 Jun 2026.

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