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
NCT ID: NCT04460885
Last Updated: 2025-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
984 participants
INTERVENTIONAL
2020-11-25
2022-12-01
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin icodec
Insulin 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
Insulin icodec
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks.
Insulin glargine
Insulin 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
Insulin glargine
Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks
Interventions
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Insulin icodec
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks.
Insulin glargine
Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Kaplan MC - Metabolic Unit
Rehovot, , Israel
Uni of Alabama at Birmingham
Birmingham, Alabama, United States
Lakeview Clinical Research, LLC
Guntersville, Alabama, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Anaheim Clinical Trials
Anaheim, California, United States
Advanced Clinical Research/Rancho Paseo Medical Group
Banning, California, United States
American Clinical Trials
Buena Park, California, United States
San Fernando Valley Hlth Inst, LLC
Canoga Park, California, United States
Med Center Medical Clinic
Carmichael, California, United States
Headlands Research California, LLC
Escondido, California, United States
Valley Research
Fresno, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
First Valley Medical Group
Lancaster, California, United States
Clinical Trials Research_Sacramento
Lincoln, California, United States
Torrance Clin Res Inst, Inc.
Lomita, California, United States
Providence Clinical Research
North Hollywood, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
NorCal Endocrinology and Internal Medicine_Roseville
Roseville, California, United States
Diabetes Research Center
Tustin, California, United States
Coastal Metabolic Research Center
Ventura, California, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Revival Research
Doral, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
University Of Miami
Miami, Florida, United States
Suncoast Clin Res Port Richey
New Port Richey, Florida, United States
Florida Inst For Clin Res
Orlando, Florida, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
Clinical Research of Cent FL
Winter Haven, Florida, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Physicians Research Assoc. LLC
Lawrenceville, Georgia, United States
RNA America Health Sciences
Sugar Hill, Georgia, United States
East West Medical Research Institute_Honolulu
Honolulu, Hawaii, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Clinical Invest Special_Gurnee
Gurnee, Illinois, United States
Central Illinois Diabetes and Clinical Research
Springfield, Illinois, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Cotton-O'Neil Diab & Endo Ctr
Topeka, Kansas, United States
St Elizabeth Physicians Heart
Covington, Kentucky, United States
Four Rivers Clinical Research Inc
Paducah, Kentucky, United States
MedStar Hlth Res Institute
Hyattsville, Maryland, United States
Endo And Metab Cons
Rockville, Maryland, United States
Arcturus Healthcare, PLC.
Troy, Michigan, United States
Diabetes & Endo Specialists Inc
Chesterfield, Missouri, United States
Methodist Phys. Clinic
Omaha, Nebraska, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Southern NH Diabetes and Endo_Nashua
Nashua, New Hampshire, United States
Albuquerque Clin Trials, Inc.
Albuquerque, New Mexico, United States
N.Y. Total Medical Care PC
Brooklyn, New York, United States
Northwell Health Div of Endo
Great Neck, New York, United States
NYU Grossman School of Med
New York, New York, United States
Endocrine Associates of Long Island, PC
Smithtown, New York, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Physicians East Endocrinology
Greenville, North Carolina, United States
Medication Management, LLC
Raleigh, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Ardmore Family Practice
Winston-Salem, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, United States
Providence Health Partners Ctr
Dayton, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, United States
Clinical Research Source Inc
Perrysburg, Ohio, United States
Intend Research
Norman, Oklahoma, United States
Oregon Health & Science University_Portland
Portland, Oregon, United States
Heritage Valley Medical Group Inc
Beaver, Pennsylvania, United States
Indiana-Armstrong Endocrinology Associates
Indiana, Pennsylvania, United States
The Diabetes Center, LLC
Murrells Inlet, South Carolina, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, United States
AM Diabetes And Endocrinology Center
Bartlett, Tennessee, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Texas Diab & Endo, P.A.
Austin, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
PrimeCare Medical Group
Houston, Texas, United States
JCCT- Juno NW Houston
Houston, Texas, United States
Fmc Science, Llc
Lampasas, Texas, United States
Texas Diab & Endo, P.A.
Round Rock, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
NE Clin Res of San Antonio
San Antonio, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Elite Medical Care
Sugar Land, Texas, United States
Wade Family Medicine
Bountiful, Utah, United States
Advanced Research Institute
Ogden, Utah, United States
Chrysalis Clinical Research
St. George, Utah, United States
Danville Internal Medicine Inc
Danville, Virginia, United States
TPMG Clinical Research
Newport News, Virginia, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Poliklinika SLAVONIJA OSIJEK
Osijek, County of Osijek-Baranja, Croatia
Opca bolnica Karlovac
Karlovac, , Croatia
KBC Rijeka, Endokrinologija
Rijeka, , Croatia
Opca bolnica Varazdin_Endocrinology
Varaždin, , Croatia
PGIMS Rohtak
Rohtak, Haryana, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India
BYL Nair Hospital and T N Medical College Department of endo
Mumbai, Maharashtra, India
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, India
chelleram Diabetes Institute
Pune, Maharashtra, India
All India Institute of Medical Sciences
New Dehli, New Delhi, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, India
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, India
Gandhi Hospital & Medical college
Hyderabad, Telangana, India
Osmania General Hospital
Hyderabad, Telangana, India
Ramdev Rao Hospital
Hyderabad, Telangana, India
SSKM
Kolkata, West Bengal, India
Soroka MC - Outpatient Diabetes Clinic
Beersheba, , Israel
Wolfson MC - Diabetes Clinic
Holon, , Israel
Hadassah Ein Karam MC - Diabetes Unit
Jerusalem, , Israel
Diabetes Clinic Meir MC
Kfar Saba, , Israel
Rabin MC Beilinson - Department of Cardiothoracic Surgery
Petah Tikva, , Israel
Policlinico Umberto I Seconda Clinica Medica
Roma, RM, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Policlinico Mater Domini Università di Catanzaro
Catanzaro, , Italy
Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
Milan, , Italy
Policlinico Universitario Paolo Giaccone
Palermo, , Italy
Hayashi Diabetes Clinic
Chigasaki-shi, Kanagawa, Kanagawa, Japan, Japan
Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
Chigasaki-shi, Kanagawa, Japan, Japan
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, Japan
The University of Tokyo Hospital, Diabetes and Metabolic
Bunkyo-ku, Tokyo, , Japan
Tokuyama clinic_Diabetic internal medicine
Chiba, , Japan
Futata Tetsuhiro Clinic Meinohama_Internal medicine
Fukuoka-shi, Fukuoka, , Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, , Japan
Sugimoto Clinic,Internal Medicine
Kitakyusyu-shi, Fukuoka, , Japan
Toranomon Hospital, Endocrinology and Metabolism
Minato-ku, Tokyo, , Japan
Shinden Higashi Clinic_Miyagi
Miyagi, , Japan
Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.
Osaka, , Japan
Shimizu Clinic Fusa
Saitama, , Japan
Wakakusa Clinic
Shimotsuke-shi, Tochigi, , Japan
Oyama East Clinic_Internal Medicine
Tochigi, , Japan
Noritake Clinic
Ushiku-shi, Ibaraki, , Japan
InstitutoJalisciense de Investigación en Diabetes y Obesidad
Guadalajara, Jalisco, Mexico
Clínica Omega Diabetes, S.C.
Mexico City, México, D.F., Mexico
Hospital Universitario Dr. José Eleuterio González_Monterrey
Monterrey, Nuevo León, Mexico
Investigación Médica Sonora S.C.
Hermosillo, Sonora, Mexico
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, Poland
NZOZ "CenterMed Lublin" Sp. z o.o.
Lublin, Lublin Voivodeship, Poland
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, Lubusz Voivodeship, Poland
NBR Polska Tomasz Klodawski
Warsaw, Masovian Voivodeship, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne "Diabetika"
Radom, , Poland
Centrum Zdrowia Tuchow Sp z o.o.
Wierzchosławice, , Poland
Prywatny Gabinet Janusz Gumprecht
Zabrze, , Poland
Advanced Clinical Research LLC
Bayamón, , Puerto Rico
Manati Ctr For Clin Research
Manatí, , Puerto Rico
Consultorio Medico
San Juan, , Puerto Rico
SAHI Kuzbass Hospital(former Regional clinical hospital)
Kemerovo, , Russia
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
Moscow, , Russia
Setchenov First Moscow State Medical University
Moscow, , Russia
Limited Law Company "Healthy Family" Medicine Center"
Novosibirsk, , Russia
Scientifc Institute of Clinical and Experimental Lymphology
Novosibirsk, , Russia
Penza Regional Clinical Hospital named after N.N. Burdenko
Penza, , Russia
Limited Liability Company "Energiya Zdoroviya"
Saint Petersburg, , Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
Medinet LLC
Saint Petersburg, , Russia
Consultative & Diagnostic Center with a Outpatient Hospital
Saint Petersburg, , Russia
Regional clinical cardiology dispensary
Saratov, , Russia
Siberian State Medical University
Tomsk, , Russia
Voronezh Regional Clinical Consultive-diagnostic Centre
Voronezh, , Russia
Polyclinic #2 in Yoshkar-Ola
Yoshkar-Ola, , Russia
Peter Farkas MD, s.r.o.
Šahy, Slovak Republic, Slovakia
Amb. diabetologie a poruch latkovej premeny a vyzivy
Bratislava, , Slovakia
Diacrin s. r. o.
Bratislava, , Slovakia
MEDISPEKTRUM s.r.o.
Bratislava, , Slovakia
MediVet s.r.o.
Malacky, , Slovakia
SIN AZUCAR s.r.o.
Malacky, , Slovakia
Diabetologicka ambulancia SchronerMED, s.r.o.
Moldava nad Bodvou, , Slovakia
ARETEUS s.r.o.
Trebišov, , Slovakia
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
ABS La Roca del Vallés_Endocrinología
La Roca Del Vallés, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Centro de Especialidades José Marva
Madrid, , Spain
Hospital Quirón
Pozuelo de Alarcón, , Spain
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, , Spain
Bollington Medical Centre
Bollington, Cheshire, United Kingdom
Layton Medical Centre
Blackpool, , United Kingdom
The Health Centre
Bradford-on-Avon, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Addenbrooke's Hospital_Cambridge
Cambridge, , United Kingdom
Countess of Chester Hospital
Chester, , United Kingdom
The Adam Practice
Dorset, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Wycombe General Hospital
High Wycombe, , United Kingdom
Burbage Surgery
Hinckley, , United Kingdom
Queen Alexandra Hospital_Portsmouth
Portsmouth, , United Kingdom
The Staploe Medical Centre
Soham, , United Kingdom
Joint Clinical Research Facility - Swansea
Swansea, , United Kingdom
Royal Cornwall Hospital (Treliske)
Truro, , United Kingdom
Albany House Medical Centre
Wellingborough, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1247-3878
Identifier Type: OTHER
Identifier Source: secondary_id
2020-000442-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1436-4477
Identifier Type: -
Identifier Source: org_study_id
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