AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3ONWARDS 5NCT04760626

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

A Phase 3 study testing Insulin icodec, Insulin Glargine 100U/mL and Insulin Degludec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 311 sites in 10 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 to different daily insulins in people with type 2 diabetes. The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once 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 100U/mL and Insulin Degludec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,085 participants
Where
311 sitesin 10 countries
Study dates
1 Mar 2021to 29 Aug 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

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • Male or female.
  • Age 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 above 7.0% (53 mmol/mol) as measured by central lab.
  • 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 antidiabetic 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 non-insulin antidiabetic 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):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists.
  • Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

Who cannot join

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Previous participation in this trial. Participation is defined as signed informed consent.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)
  • Any disorder which in the investigator's opinion might jeopardise subject's safety.

Trial locations and contacts

311 sites in 10 countries.

311 sites in 10 countries

United States142 sites

  • AMC Community Endocrinology

    Albany, New York, 12203

  • Albuquerque Clin Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Athens Medical Group

    Athens, Tennessee, 37303

  • Emory University SOM

    Atlanta, Georgia, 30303

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Texas Diab & Endo, P.A.

    Austin, Texas, 78731

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78749

  • American Health Network of Indiana, LLC_Avon_0

    Avon, Indiana, 46123

  • 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

  • Rocky Mountain Health Network

    Billings, Montana, 59102

  • Univ of Alabama Birmingham

    Birmingham, Alabama, 35233

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Progressive Clinical Research UT

    Bountiful, Utah, 84010

  • N.Y. Total Medical Care PC

    Brooklyn, New York, 11215

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • American Clinical Trials

    Buena Park, California, 90620

  • San Fernando Valley Hlth Inst, LLC

    Canoga Park, California, 91304

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718

  • Med Center Medical Clinic

    Carmichael, California, 95608

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • PMG Research of Charlotte

    Charlotte, North Carolina, 28209

  • Chatham Family Medical Center

    Chatham, Virginia, 24531

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • Univ Diab & Endo Consultants

    Chattanooga, Tennessee, 37411

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Diabetes & Endo Specialists Inc

    Chesterfield, Missouri, 63017

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Clinical Res Of W Florida Inc

    Clearwater, Florida, 33765

  • The Ohio State University Medical Center

    Columbus, Ohio, 43203

  • 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

  • Danville Internal Medicine Inc

    Danville, Virginia, 24541-2834

  • Providence Health Partners Ctr

    Dayton, Ohio, 45439

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Revival Research

    Doral, Florida, 33122

  • Denver Endocrinology Diabetes and Thyroid Center

    Englewood, Colorado, 80113

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Clinical Research Advantage, Inc.-Evansville

    Evansville, Indiana, 47714

  • Plains Clinical Research Center, LLC_Fargo

    Fargo, North Dakota, 58104

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Valley Research

    Fresno, California, 93720

  • Pri Med Grp dba/Gil Ctr Fam

    Gilbert, Arizona, 85296

  • Northwell Health Div of Endo

    Great Neck, New York, 11021

  • Physicians East Endocrinology

    Greenville, North Carolina, 27834

  • Lakeview Clinical Research, LLC

    Guntersville, Alabama, 35976

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California, 90250

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • PrimeCare Medical Group

    Houston, Texas, 77024

  • Juno Research, LLC

    Houston, Texas, 77074

  • Endocrine And Psychiatry Center

    Houston, Texas, 77095

  • Diabetes/Lipid Mgmt & Res Ctr

    Huntington Beach, California, 92648

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • MedStar Community Clin Res Ctr

    Hyattsville, Maryland, 20782

  • Indiana-Armstrong Endocrinology Associates

    Indiana, Pennsylvania, 15701

  • Est Cst Inst for Rsrch,Jksnvil

    Jacksonville, Florida, 32216

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida, 32216

  • Jefferson City Medical Group, PC

    Jefferson City, Missouri, 65109

  • Medical Colleagues-Texas LLP

    Katy, Texas, 77450

  • Clinical Investigation Specialists Inc, Kenosha

    Kenosha, Wisconsin, 53144

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Altman Clin & Trans Res Inst

    La Jolla, California, 92037

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

  • Fmc Science, Llc

    Lampasas, Texas, 76550

  • First Valley Medical Group

    Lancaster, California, 93534

  • Andres Garcia-Zuniga, MD, P.A

    Laredo, Texas, 78041

  • 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

  • Torrance Clin Res Inst, Inc.

    Lomita, California, 90717

  • Adventist Health White Memorial

    Los Angeles, California, 90033

  • Your Diabetes Endocrine Nutrition Group, Inc.

    Mentor, Ohio, 44060

  • University Of Miami

    Miami, Florida, 33136

  • HealthStar Physicians PC

    Morristown, Tennessee, 37813

  • Adult Medicine of Lake County, Inc

    Mt. Dora, Florida, 32757

  • The Diabetes Center, LLC

    Murrells Inlet, South Carolina, 29576

  • Southern New Hampshire Diabetes and Endocrinology

    Nashua, New Hampshire, 03060

  • Southern New Hampshire Diabete

    Nashua, New Hampshire, 03060

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Suncoast Clin Res Port Richey

    New Port Richey, Florida, 34652

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York, 12553

  • CTSI Research Center

    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

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • 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

  • Tristar Clin Investigations, PC

    Philadelphia, Pennsylvania, 19114

  • 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

  • Endo Res Solutions Inc

    Roswell, Georgia, 30076

  • Endo Res Solutions, Inc

    Roswell, Georgia, 30076

  • Texas Diab & Endo, P.A.

    Round Rock, Texas, 78681

  • Clinical Trials Research_Sacramento

    Sacramento, California, 95821

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • NE Clin Res of San Antonio

    San Antonio, Texas, 78233

  • San Diego Family Care

    San Diego, California, 92111

  • 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

  • Encompass Clinical Research_Spring Valley

    Spring Valley, California, 91978

  • Central Illinois Diabetes and Clinical Research

    Springfield, Illinois, 62711

  • St Johns Health System

    Springfield, Missouri, 65807-7304

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Staten Island Diabetes

    Staten Island, New York, 10301-3914

  • RNA America Health Sciences

    Sugar Hill, Georgia, 30518

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478

  • Elite Medical Care

    Sugar Land, Texas, 77479

  • SUNY Upstate Medical University_Syracuse_0

    Syracuse, New York, 13131

  • Handelsman Yehuda

    Tarzana, California, 91356-3551

  • Javara Inc.

    The Woodlands, Texas, 77382

  • Cotton O'Neil Diab & Endo Ctr

    Topeka, Kansas, 66606

  • Arcturus Healthcare, PLC.

    Troy, Michigan, 48098

  • Diabetes Research Center

    Tustin, California, 92780

  • Coastal Metabolic Research Center

    Ventura, California, 93003

  • New Venture Medical Research

    Wadsworth, Ohio, 44281

  • MassResearch, LLC_Waltham

    Waltham, Massachusetts, 02453

  • MedStar Diabetes Institute

    Washington D.C., District of Columbia, 20010

  • 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

    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

Canada67 sites

  • LMC Diabetes & Endocrinology (Barrie)

    Barrie, Ontario, L4N 7L3

  • Centricity Research LMC (Toronto)

    Brampton, Ontario, L6S 0C6

  • Clinique Santé Dix30

    Brossard, Quebec, J4Y 0E2

  • ViaCar Recherche Clinique Inc

    Brossard, Quebec, J4Z 2K9

  • LMC Clin Res Inc. Calgary

    Calgary, Alberta, T2H 2G4

  • Dawson Clinical Research

    Cambridge, Ontario, N1H 1B1

  • Joanne F. Liutkus Medicine Professional Corporation

    Cambridge, Ontario, N1R 7L6

  • Saul Vizel Pro. Med. Corp

    Cambridge, Ontario, N1R 7R1

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • LMC Clinical Res Thornhill

    Concord, Ontario, L4K 4M2

  • Medical Trust Clinics, Inc.

    Courtice, Ontario, L1E2J5

  • LMC Endo Ctr (Etobicoke) Ltd

    Etobicoke, Ontario, M9R 4E1

  • Janik Research

    Greater Sudbury, Ontario, P3B 4H5

  • Four Corners Walk-In Clinic

    Greater Sudbury, Ontario, P3E 1Y8

  • Wharton Medical Clinic Clinical Trials (Hamilton)

    Hamilton, Ontario, L8L 5G8

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8M 1K7

  • Ctr de recherche Clinique de Laval

    Laval, Quebec, H7T 2P5

  • Milestone Research

    London, Ontario, N5W 6A2

  • St. Joseph's Hospital

    London, Ontario, N6A 4V2

  • Western Univ. Cnt for Studies in Fam Med

    London, Ontario, N6G 2M1

  • My Endo Diabetes & Endo Cent

    Markham, Ontario, L3P 7P2

  • Manna Research Mirabel

    Mirabel, Quebec, J7J 2K8

  • Malton Medical Clinic

    Mississauga, Ontario, L4V1P1

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Recherche GCP Research

    Montreal, Quebec, H1Y 3H5

  • Clinique de Recherche Medpharmgene Inc.

    Montreal, Quebec, H2K 1H2

  • IRCM

    Montreal, Quebec, H2W 1R7

  • LMC Clinical Research, Inc. (Montreal Glen)

    Montreal, Quebec, H4A 2C6

  • Applied Med Inf Res

    Montreal, Quebec, H4A 3T2

  • 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

  • SKDS Research Inc.

    Newmarket, Ontario, L3Y 5G8

  • LMC Oakville

    Oakville, Ontario, L6M 1M1

  • Enhanced Care Clinic

    Oshawa, Ontario, L1J 1T4

  • Dr. James Cha

    Oshawa, Ontario, L1J 2K1

  • The Ottawa Hospital Riverside Campus

    Ottawa, Ontario, K1H7W9

  • Kawartha Cardiology Clinical Trials

    Peterborough, Ontario, K9J 0B2

  • Centricity Res Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S5

  • Recherche Clinique Sigma inc

    Québec, G1G 5X1

  • Diex Recherche Quebec

    Québec, G1V 4T3

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, G1V 4W2

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4

  • ALPHA Recherche Clinique

    Québec, G3K 2P8

  • The Bailey Clinic

    Red Deer, Alberta, T4N 6V7

  • Diex Recherche Joliette

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • LMC Clin Rsrch Inc. (Montreal)

    Saint-Laurent, Quebec, H4T 1Z9

  • Ctr Méd. et pro d l'Ost d port

    Saint-Marc-des-Carrieres, Quebec, G0A 4B0

  • Bluewater Clin Res Group,Inc

    Sarnia, Ontario, N7T 4X3

  • Q & T Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1J 2G2

  • Canadian Centre for Research on Diabetes

    Smiths Falls, Ontario, K7A 4W8

  • Eastern Health Authority

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

  • Winterberry Family Medicine

    Stoney Creek, Ontario, L8J 0B6

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z 2N6

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 0K2

  • Keele Medical

    Toronto, Ontario, M3M3E5

  • Stephen S. Chow Medicine Professional Corporation

    Toronto, Ontario, M4C 5T2

  • LMC Endo Centres Ltd.(Bayview)

    Toronto, Ontario, M4G 3E8

  • Leadership Sinai Centre for Diabetes, Mount Sinai Hospital

    Toronto, Ontario, M5T 3L9

  • Dr Anil K Gupta Med Prof Corp

    Toronto, Ontario, M9V 4B4

  • BC Diabetes Canada

    Vancouver, British Columbia, V5Y 3W2

  • Saint Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Dr. M.B. Jones Inc

    Victoria, British Columbia, V8V 4A1

  • Diex Recherche Victoriaville

    Victoriaville, Quebec, G6P 6P6

  • Rivergrove Medical Clinic

    Winnipeg, Manitoba, R2V 4W3

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Poland23 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Szpital Specjalistyczny Nr 2 Poradnia Diabetologiczna

    Bytom, 41-902

  • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

    Gdansk, 80-858

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomeranian Voivodeship, 81-338

  • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

    Gorzów Wielkopolski, Lubusz Voivodeship, 66-400

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET

    Krakow, 31-261

  • Gabinet Lekarski Malgorzata Saryusz-Wolska

    Lodz, 90-132

  • Gabinet Lekarski Katarzyna Cypryk

    Lodz, 90-553

  • Pro Salus Centrum Medyczne

    Lodz, 91-473

  • Qualimed

    Lodz, 91-849

  • NZOZ Przychodnia Specjalistyczna Medica

    Lublin, Lubelski, 20-538

  • Katedra i Klinika Chorob Wewnetrznych AM w Lublinie

    Lublin, 20-081

  • Oddzial Chorób - Wewn.

    Poznan, 60-834

  • Velocity Nova Sp. z o.o.

    Puławy, 24-100

  • Niepubliczny Zakład Opieki Zdrowotnej Beta-Med

    Rzeszów, 35-073

  • Velocity Nova Sp. z o.o.

    Staszów, Świętokrzyskie Voivodeship, 28-200

  • Lubelskie Centrum Diagnostyczne Tomasz Blicharski

    Świdnik, 21-040

  • NBR Polska Tomasz Klodawski

    Warsaw, 00-710

  • SP CSK Klinika Diabetologii i Chorob Wewnetrznych

    Warsaw, 02-097

  • Master Center for Poland

    Warsaw, PL-02-274

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

  • Poradnia dla Chorych na Cukrzycę

    Zabrze, 41-800

Other trials in Poland

Greece16 sites

  • NIMTS Army Share Fund Hospital

    Athens, 115 21

  • Iatriko Psychicou Private Clinic

    Athens, 115 25

  • 'G. Gennimatas' General Hospital of Athens

    Athens, 115 27

  • Group Euroclinic - Athens Euroclinic

    Athens, 11521

  • "Laiko" General Hospital of Athens

    Athens, 11527

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, 17562

  • General Hospital Of Athens Korgialenio Benakio H.R.C. - Department of Endocrinology

    Athens, GR-11526

  • Gen Hosp Athens Ippokrateio,B' Uni Clinic Internal Medicine

    Athens, GR-11527

  • Univ Gen Hospital Larisa

    Larissa, 41110

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, 54635

  • AHEPA General University Hospital

    Thessaloniki, 54636

  • "Ippokrateio" G.H. of Thessaloniki

    Thessaloniki, 54642

  • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes

    Thessaloniki, 54645

  • "Thermi" Private Hosital

    Thessaloniki, 57001

  • General Hospital of Thessaloniki "G.Papanikolaou"

    Thessaloniki, 57010

  • "Ippokrateio" General Hosp Thessaloniki, A' Internal Med

    Thessaloniki, GR-54642

Other trials in Greece

Turkey (Türkiye)15 sites

  • Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi

    Adana, 01250

  • Ankara Üniversitesi Tıp Fakültesi İbni Sina Hastanesi-Endokrinoloji

    Ankara, 06100

  • Eskişehir Osmangazi Üniversitesi Sağlık, Uygulama ve Araştırma Hastanesi

    Eskişehir, 26040

  • Gaziantep Üniversitesi Hastanesi

    Gaziantep, 27070

  • Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm

    Hatay, 31060

  • Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi

    Istanbul, 34303

  • Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji

    Istanbul, 34371

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji

    Istanbul, 34390

  • Haydarpaşa Numune Eğitim ve Araştırma Hastanesi

    Istanbul, 34718

  • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

    Istanbul, 34722

  • Umraniye Egitim ve Arastirma Hastanesi

    Istanbul, 34760

  • T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34899

  • Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi-Endokrinoloji

    Izmir, 35340

  • Erciyes Üniversitesi Hastanesi- Endokrinoloji

    Kayseri, 38039

  • Adana Şehir Eğitim ve Araştırma Hastanesi

    Yüreğir/Adana, 1370

Other trials in Turkey (Türkiye)

Germany14 sites

  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980

  • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

    Berlin, 13597

  • InnoDiab Forschung GmbH

    Essen, 45136

  • Zentrum für klinische Forschung, Dr. med. Lüdemann

    Falkensee, 14612

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607

  • Dr. Milek medikum

    Hohenmölsen, 06679

  • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

    Münster, 48145

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758

  • Praxis Dr. med. Wenzl-Bauer

    Rehlingen-Siersburg, 66780

  • Med.Versorgungszentrum Riesa-Dr. Bieler

    Riesa, 01587

  • Zentrum für klinische Studien Alexander Segner

    Saint Ingbert-Oberwürzbach, 66386

  • MZM Praxis Drs. Erlinger

    Stuttgart, 70378

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239

Other trials in Germany

Hungary13 sites

  • Óbudai Egészségügyi Centrum

    Budapest, Pest County, 1036

  • Szent Margit Kórház

    Budapest, 1032

  • Szőcs Depot Egészségügyi Szolgáltató Kft.

    Budapest, 1042

  • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1089

  • MED-TIMA Kft.

    Budapest, 1132

  • MH Egészségügyi Központ

    Budapest, 1134

  • Uno Medical Trials Eü. Szolgáltató és Kereskedelmi Kft.

    Budapest, 1152

  • Belinus Bt.

    Debrecen, Hajdú-Bihar, 4025

  • Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Komáromi Selye János Kórház

    Komárom, Komárom-Esztergom, 2900

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6725

  • Vas Vármegyei Markusovszky Egyetemi Oktatókórház

    Szombathely, 9700

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, 8900

Other trials in Hungary

Bulgaria11 sites

  • UMHAT - Burgas AD

    Burgas, 8000

  • Medical Center Cherven bryag EOOD

    Cherven Bryag, 5980

  • Medical Center Zdrave Lom EOOD

    Lom, 3600

  • MHAT - Pazardzhik AD

    Pazardzhik, 4401

  • UMHAT Kanev AD

    Rousse, 7000

  • MHAT Dr. Bratan Shukerov

    Smolyan, 4700

  • Medical Institute of Ministry of interior

    Sofia, 1606

  • UMHAT Sofiamed EAD

    Sofia, 1797

  • UMHAT Sveta Marina EAD, Clinic of Internal Diseases

    Varna, 9010

  • Medical center - Varna

    Varna

  • MHAT Sveti Panteleimon - Yambol AD

    Yambol, 8600

Other trials in Bulgaria

Serbia7 sites

  • CHC Zvezdara, Clinical department for endocrinology

    Belgrade, 11000

  • Endocrinology, Diabetes and Metabolism Diseases Clinic

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

    Kragujevac, 34000

  • Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.

    Novi Sad, Vojvodina, 21000

  • Policlinic for diabetes

    Zaječar, 19000

Other trials in Serbia

Puerto Rico3 sites

  • Instituto De Endronilogia Diabetes Y Metabolismo

    Bayamón, 00961

  • Manati Ctr For Clin Research

    Manati, 00674

  • Consultorio Medico

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting

This study compares insulin icodec to different daily insulins in people with type 2 diabetes.

The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random.

Read more

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App.

The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken.

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

Being tested
Insulin icodec, Insulin Glargine 100U/mL, Insulin Degludec, Insulin Glargine 300U/mL
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 52 weeks.

  • Insulin Glargine 100U/mLDrug

    Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

  • Insulin DegludecDrug

    Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

  • Insulin Glargine 300U/mLDrug

    Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Study groups in NCT04760626
Study groupRoleWhat they receive
Insulin icodec with DoseGuideExperimentalParticipants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.
Receives: Drug: Insulin icodec
Once daily basal insulin analoguesActive comparatorParticipants randomised to basal insulin analogue injections once daily
Receives: Drug: Insulin Glargine 100U/mL; Drug: Insulin Degludec; Drug: Insulin Glargine 300U/mL

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 52 is presented.

    Measured: Baseline (week 0), week 52

Secondary outcomes (6)

  1. Time From Baseline to Treatment Discontinuation or Intensification

    Time from baseline to treatment discontinuation or intensification from baseline (week 0) to week 52 is presented.

    Measured: From baseline (week 0) to week 52

  2. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction

    Change in DTSQs in total treatment satisfaction is presented. The DTSQs questionnaire was used to assess participants treatment satisfaction which contained 8 components (DTSQs Item 1-8 : how satisfied are you with your current treatment, how often have you felt that blood sugars have been unacceptably high, how often have you felt that blood sugars have been unacceptably low, how convenient have you been finding your treatment to be recently, how flexible have you been finding your treatment to be recently, how satisfied are you with your understanding of your diabetes, would you recommend treatment to someone else with your kind of diabetes, how satisfied would you be to continue with present form of treatment). The result presented is the treatment satisfaction summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Total scores for treatment satisfaction range from 0-36 with 0 being the lowest and 36 being the highest score in total treatment satisfaction.

    Measured: Baseline (week 0), week 52

  3. Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance Domain

    Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance domain at week 52 is presented. The TRIM-D questionnaire was developed to capture the impact of diabetes treatment on patients' functioning and well-being. The questionnaire was used to measure the compliance between the treatment groups. The total TRIM-D compliance score is computed by summing across the items and then transforming to a 0-100 scale with higher score indicating better compliance.

    Measured: At end of treatment (week 52)

  4. 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 57

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

    Number of clinically significant hypoglycaemic episodes (level 2) (below 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.

    Measured: From baseline (week 0) to week 57

  6. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 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) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) 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. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.

    Measured: From baseline (week 0) to week 57

Timeline

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

  1. First posted18 Feb 2021
  2. Study start1 Mar 2021
  3. Primary completion12 Aug 2022
  4. Study completion29 Aug 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
1,085 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04760626
Sponsor's protocol ID
NN1436-4481
Other IDs
U1111-1247-5279, 2020-000476-38
Acronym
ONWARDS 5
Status last verified
Aug 2026
First submitted
17 Feb 2021
Last updated
11 Aug 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

  • 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

  • Billings LK, Asong M, Bog M, Clancy S, Kruse C, de Laguiche E, Maddaloni E. AUGMENTed Real-World Data Enhances Comparative Efficacy Between Once-Weekly Insulin Icodec with Dosing Guide App Versus Once-Daily Insulin Glargine U300 in Insulin-Naive Type 2 Diabetes. Diabetes Ther. 2025 Feb;16(2):227-239. doi: 10.1007/s13300-024-01679-3. Epub 2024 Dec 19.

    PubMed 39699848

  • 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.

    PubMed 39368488

  • Bajaj HS, Aberle J, Davies M, Donatsky AM, Frederiksen M, Yavuz DG, Gowda A, Lingvay I, Bode B. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5) : A Randomized Trial. Ann Intern Med. 2023 Nov;176(11):1476-1485. doi: 10.7326/M23-1288. Epub 2023 Sep 26.

    PubMed 37748181

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin icodec, Insulin Glargine 100U/mL and Insulin Degludec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 311 sites in 10 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 8 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 311 sites in United States, Canada, Poland, Greece, Turkey (Türkiye) and 5 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 26 Aug 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 52). 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 NCT04760626, 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 11 Aug 2026.

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