AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3ONWARDS 1NCT04460885

A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before

A Phase 3 study testing Insulin icodec and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 198 sites in 13 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?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin icodec and Insulin glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
984 participants
Where
198 sitesin 13 countries
Study dates
25 Nov 2020to 1 Dec 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 type 2 diabetes mellitus (T2D) 180 days or more prior to the day of screening.
  • HbA1c 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) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a. Any metformin formulations at least or greater than 1500 mg or maximum tolerated or effective dose. b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes including combinations ((equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral anti-diabetic drugs), Oral or injectable glucagon-like peptide 1 (GLP-1) receptor agonists
  • Body mass index (BMI) equal to or below 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

198 sites in 13 countries.

198 sites in 13 countries

United States97 sites

  • Albuquerque Clin Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Anaheim Clinical Trials

    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 Medical Group Inc

    Beaver, Pennsylvania, 15009

  • Uni of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • 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

  • 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

  • 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

  • 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

  • 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

  • Physicians East Endocrinology

    Greenville, North Carolina, 27834

  • Lakeview Clinical Research, LLC

    Guntersville, Alabama, 35976

  • Clinical Invest Special_Gurnee

    Gurnee, Illinois, 60031

  • East West Medical Research Institute_Honolulu

    Honolulu, Hawaii, 96814

  • PrimeCare Medical Group

    Houston, Texas, 77024

  • JCCT- Juno NW Houston

    Houston, Texas, 77040

  • MedStar Hlth Res Institute

    Hyattsville, Maryland, 20782

  • Indiana-Armstrong Endocrinology Associates

    Indiana, Pennsylvania, 15701

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida, 32216

  • 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, 89128

  • 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 NH Diabetes and Endo_Nashua

    Nashua, New Hampshire, 03060

  • Suncoast Clin Res Port Richey

    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 Phys. Clinic

    Omaha, Nebraska, 68114

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198-3020

  • Florida Inst For Clin Res

    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

  • Oregon Health & Science University_Portland

    Portland, Oregon, 97239-3098

  • Medication Management, LLC

    Raleigh, North Carolina, 27609

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Endo And Metab Cons

    Rockville, Maryland, 20852

  • NorCal Endocrinology and Internal Medicine_Roseville

    Roseville, California, 95661

  • 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

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538

  • Endocrine Associates of Long Island, PC

    Smithtown, New York, 11787

  • Central Illinois Diabetes and Clinical Research

    Springfield, Illinois, 62711

  • 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-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

  • 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

United Kingdom16 sites

  • Layton Medical Centre

    Blackpool, FY3 7EN

  • Bollington Medical Centre

    Bollington, Cheshire, SK10 5JH

  • The Health Centre

    Bradford on Avon, BA15 1DQ

  • Southmead Hospital

    Bristol, BS10 5NB

  • Addenbrooke's Hospital_Cambridge

    Cambridge, CB2 0QQ

  • Countess of Chester Hospital

    Chester, CH2 1UL

  • The Adam Practice

    Dorset, BH16 5PW

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Wycombe General Hospital

    High Wycombe, HP11 2TT

  • Burbage Surgery

    Hinckley, LE10 2SE

  • Queen Alexandra Hospital_Portsmouth

    Portsmouth, PO6 3LY

  • The Staploe Medical Centre

    Soham, CB7 5JD

  • Joint Clinical Research Facility - Swansea

    Swansea, SA2 8PP

  • Royal Cornwall Hospital (Treliske)

    Truro, TR1 3LJ

  • Albany House Medical Centre

    Wellingborough, NN8 4RW

Other trials in United Kingdom

Japan15 sites

  • The University of Tokyo Hospital, Diabetes and Metabolic

    Bunkyo-ku, Tokyo, 113-8655

  • Tokuyama clinic_Diabetic internal medicine

    Chiba, 261-0004

  • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine

    Chigasaki-shi, Kanagawa, Japan, 253-0044

  • Hayashi Diabetes Clinic

    Chigasaki-shi, Kanagawa, Kanagawa, Japan, 253-0044

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

  • Sugimoto Clinic,Internal Medicine

    Kitakyusyu-shi, Fukuoka, 800-0222

  • Toranomon Hospital, Endocrinology and Metabolism

    Minato-ku, Tokyo, 105-8470

  • Shinden Higashi Clinic_Miyagi

    Miyagi, 983-0039

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034

  • Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.

    Osaka, 569-1045

  • Shimizu Clinic Fusa

    Saitama, 336-0967

  • Wakakusa Clinic

    Shimotsuke-shi, Tochigi, 329-0433

  • Oyama East Clinic_Internal Medicine

    Tochigi, 323-0022

  • Noritake Clinic

    Ushiku-shi, Ibaraki, 300-1207

Other trials in Japan

Russia14 sites

  • SAHI Kuzbass Hospital(former Regional clinical hospital)

    Kemerovo, 650066

  • FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia

    Moscow, 117292

  • Setchenov First Moscow State Medical University

    Moscow, 119435

  • Limited Law Company "Healthy Family" Medicine Center"

    Novosibirsk, 630099

  • Scientifc Institute of Clinical and Experimental Lymphology

    Novosibirsk, 630117

  • Penza Regional Clinical Hospital named after N.N. Burdenko

    Penza, 440052

  • Limited Liability Company "Energiya Zdoroviya"

    Saint Petersburg, 194156

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • Medinet LLC

    Saint Petersburg, 194356

  • Consultative & Diagnostic Center with a Outpatient Hospital

    Saint Petersburg, 197110

  • Regional clinical cardiology dispensary

    Saratov, 410039

  • Siberian State Medical University

    Tomsk, 634050

  • Voronezh Regional Clinical Consultive-diagnostic Centre

    Voronezh, 394018

  • Polyclinic #2 in Yoshkar-Ola

    Yoshkar-Ola, 424004

Other trials in Russia

India12 sites

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • Gandhi Hospital & Medical college

    Hyderabad, Telangana, 500003

  • Osmania General Hospital

    Hyderabad, Telangana, 500012

  • Ramdev Rao Hospital

    Hyderabad, Telangana, 500072

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh, 452010

  • SSKM

    Kolkata, West Bengal, 700020

  • BYL Nair Hospital and T N Medical College Department of endo

    Mumbai, Maharashtra, 400008

  • Seth GS medical college and KEM Hospital

    Mumbai, Maharashtra, 400012

  • All India Institute of Medical Sciences

    New Dehli, New Delhi, 110029

  • chelleram Diabetes Institute

    Pune, Maharashtra, 411021

  • PGIMS Rohtak

    Rohtak, Haryana, 124001

  • Christian Medical College Hospital, Vellore

    Vellore, Tamil Nadu, 632004

Other trials in India

Poland8 sites

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie Voivodeship, 15-435

  • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

    Gorzów Wielkopolski, Lubusz Voivodeship, 66-400

  • NZOZ Przychodnia Specjalistyczna Medica

    Lublin, Lubelski, 20-538

  • NZOZ "CenterMed Lublin" Sp. z o.o.

    Lublin, Lublin Voivodeship, 20-044

  • Centrum Medyczne "Diabetika"

    Radom, 26-600

  • NBR Polska Tomasz Klodawski

    Warsaw, Masovian Voivodeship, 00-710

  • Centrum Zdrowia Tuchow Sp z o.o.

    Wierzchosławice, 33-122

  • Prywatny Gabinet Janusz Gumprecht

    Zabrze, 41-800

Other trials in Poland

Slovakia8 sites

  • Amb. diabetologie a poruch latkovej premeny a vyzivy

    Bratislava, 821 02

  • Diacrin s. r. o.

    Bratislava, 84102

  • MEDISPEKTRUM s.r.o.

    Bratislava, 851 01

  • MediVet s.r.o.

    Malacky, 901 01

  • SIN AZUCAR s.r.o.

    Malacky, 901 01

  • Diabetologicka ambulancia SchronerMED, s.r.o.

    Moldava nad Bodvou, 045 01

  • Peter Farkas MD, s.r.o.

    Šahy, Slovak Republic, 93601

  • ARETEUS s.r.o.

    Trebišov, 07501

Other trials in Slovakia

Israel6 sites

  • Soroka MC - Outpatient Diabetes Clinic

    Beersheba, 84101

  • Wolfson MC - Diabetes Clinic

    Holon, 58100

  • Hadassah Ein Karam MC - Diabetes Unit

    Jerusalem, 91120

  • Diabetes Clinic Meir MC

    Kfar Saba, 44281

  • Rabin MC Beilinson - Department of Cardiothoracic Surgery

    Petah Tikva, 49100

  • Kaplan MC - Metabolic Unit

    Rehovot, 76100

Other trials in Israel

Spain6 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • ABS La Roca del Vallés_Endocrinología

    La Roca Del Vallés, 08430

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Centro de Especialidades José Marva

    Madrid, 28020

  • Hospital Quirón

    Pozuelo de Alarcón, 28223

  • Hospital Universitario Quirónsalud Madrid

    Pozuelo de Alarcón, 28223

Other trials in Spain

Italy5 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Policlinico Mater Domini Università di Catanzaro

    Catanzaro, 88100

  • Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia

    Milan, 20122

  • Policlinico Universitario Paolo Giaccone

    Palermo, 90127

  • Policlinico Umberto I Seconda Clinica Medica

    Roma, RM, 00161

Other trials in Italy

Croatia4 sites

  • Opca bolnica Karlovac

    Karlovac, 47000

  • Poliklinika SLAVONIJA OSIJEK

    Osijek, County of Osijek-Baranja, 31000

  • KBC Rijeka, Endokrinologija

    Rijeka, 51000

  • Opca bolnica Varazdin_Endocrinology

    Varaždin, 42 000

Other trials in Croatia

Mexico4 sites

  • InstitutoJalisciense de Investigación en Diabetes y Obesidad

    Guadalajara, Jalisco, 44600

  • Investigación Médica Sonora S.C.

    Hermosillo, Sonora, 83280

  • Clínica Omega Diabetes, S.C.

    Mexico City, México, D.F., 06700

  • Hospital Universitario Dr. José Eleuterio González_Monterrey

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Puerto Rico3 sites

  • Advanced Clinical Research LLC

    Bayamón, 00959

  • Manati Ctr For Clin Research

    Manati, 00674

  • Consultorio Medico

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes

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. 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 get is decided by chance.

Read more

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 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 the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Being tested
Insulin icodec, Insulin glargine
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 78 weeks.

  • Insulin glargineDrug

    Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks

Study groups in NCT04460885
Study groupRoleWhat they receive
Insulin icodecExperimentalInsulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
Receives: Drug: Insulin icodec
Insulin glargineActive comparatorInsulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
Receives: Drug: Insulin glargine

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. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.

    Measured: Baseline (week 0), Week 52

Secondary outcomes (12)

  1. 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 mg/dL) using CGM system from week 48 to week 52 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. The in-trial period started at randomization 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), death for participants who died before any of the above.

    Measured: From week 48 to week 52

  2. Change in Fasting Plasma Glucose (FPG)

    Change in FPG from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.

    Measured: Baseline (week 0), Week 52

  3. Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 52

    Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

    Measured: From baseline (week 0) to week 52

  4. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 mg/dL] Confirmed by Blood Glucose [BG] Meter) Until Week 52

    Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia 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 main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

    Measured: From baseline (week 0) to week 52

  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) Until Week 52

    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. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

    Measured: From baseline (week 0) to week 52

  6. Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 83

    Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), 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 subject was considered exposed to trial product.

    Measured: From baseline (week 0) to week 83

  7. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL) Confirmed by BG Meter) Until Week 83

    Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia 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 on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), 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 subject was considered exposed to trial product.

    Measured: From baseline (week 0) to week 83

  8. 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) Until Week 83

    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. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. On-treatment period started at the date of first dose of trial product as recorded on the eCRF and ended at the first date of any of the following: The end of trial visit (V63), 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. On-treatment period was the period in which a participant was exposed to trial product.

    Measured: From baseline (week 0) to week 83

  9. Mean Weekly Insulin Dose

    Mean weekly insulin dose from week 50 to week 52 is presented. The outcome data was evaluated based on main on treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit, the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

    Measured: From week 50 to week 52

  10. Change in Body Weight

    Change in body weight from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.

    Measured: Baseline (week 0), Week 52

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

    Percentage of time spent < 3.0 mmol/L (54 mg/dL) from week 48 to week 52 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.

    Measured: From week 48 to week 52

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

    Percentage of time spent > 10 mmol/L (180 mg/dL) is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.

    Measured: From week 48 to week 52

Timeline

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

  1. First posted8 Jul 2020
  2. Study start25 Nov 2020
  3. Primary completion29 May 2022
  4. Study completion1 Dec 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
984 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04460885
Sponsor's protocol ID
NN1436-4477
Other IDs
U1111-1247-3878, 2020-000442-34
Acronym
ONWARDS 1
Status last verified
Nov 2025
First submitted
6 Jul 2020
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

  • 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

  • Bergenstal RM, Asbjornsdottir B, Watt SK, Lingvay I, Mader JK, Nishida T, Rosenstock J. Continuous glucose monitoring-based metrics and the duration of hypoglycaemia events with once-weekly insulin icodec versus once-daily insulin glargine U100 in insulin-naive type 2 diabetes: an exploratory analysis of ONWARDS 1. Lancet Diabetes Endocrinol. 2024 Nov;12(11):799-810. doi: 10.1016/S2213-8587(24)00220-1. Epub 2024 Oct 4.

    PubMed 39374601

  • 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

  • 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

  • Rosenstock J, Bain SC, Gowda A, Jodar E, Liang B, Lingvay I, Nishida T, Trevisan R, Mosenzon O; ONWARDS 1 Trial Investigators. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. N Engl J Med. 2023 Jul 27;389(4):297-308. doi: 10.1056/NEJMoa2303208. Epub 2023 Jun 24.

    PubMed 37356066

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin icodec and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 198 sites in 13 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 198 sites in United States, United Kingdom, Japan, Russia, India and 8 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 12 Jun 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 NCT04460885, which also lists 8 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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