A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
ONWARDS 11
A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
3 other identifiers
interventional
877
8 countries
182
Brief Summary
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2025
182 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2025
CompletedFirst Posted
Study publicly available on registry
July 22, 2025
CompletedStudy Start
First participant enrolled
August 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
September 25, 2026
September 1, 2026
1.5 years
July 14, 2025
September 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in glycosylated haemoglobin (HbA1c)
Measured in percentage (%)-points.
From baseline (week 0) to week 26
Secondary Outcomes (9)
Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))
From baseline (week-2-0) to week 22-26
Time spent less than (<)3.0 mmol/L (54 mg/dL)
From week 22 to week 26
Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)
From baseline (week-2-0) to week 22-26
Number of severe hypoglycaemic episodes (level 3)
From baseline (week 0) to week 31
Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter)
From baseline (week 0) to week 31
- +4 more secondary outcomes
Study Arms (2)
Insulin icodec + insulin aspart
EXPERIMENTALParticipants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
Insulin glargine+ insulin aspart
ACTIVE COMPARATORParticipants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
Interventions
Insulin icodec will be administered as subcutaneous injection
Insulin glargine will be administered as subcutaneous injection.
Insulin aspart will be administered as a subcutaneous injection.
Eligibility Criteria
You may qualify if:
- Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
- Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
- HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
- Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.
You may not qualify if:
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous participation in this study. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
- Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (182)
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
John Muir Health
Concord, California, 94520, United States
Headlands Research California, LLC
Escondido, California, 92025, United States
Clinical Res of Central Ca
Fresno, California, 93704, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Scripps Whittier Diabetes Inst
La Jolla, California, 92037, United States
Loma Linda University Faculty Medical Clinics
Loma Linda, California, 92354, United States
Pacific Clinical Studies
Los Alamitos, California, 90720, United States
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015, United States
Pasadena Clinical Trials
Pasadena, California, 91101, United States
WestenU Health
Pomona, California, 91766, United States
Alliance Clinical Network
San Diego, California, 92120, United States
Mills Health Center
San Mateo, California, 94401, United States
Center for Endocrine DM and Metabolic Disorders
Santa Clarita, California, 91321, United States
University Clin Investigators
Tustin, California, 92780, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, 80113, United States
Optumcare Clinical Trials,LLC-Golden
Golden, Colorado, 80401, United States
Northeast Research Institute
Fleming Island, Florida, 32003, United States
Encore Medical Research LLC
Hollywood, Florida, 33024, United States
Northeast Research Institute
Jacksonville, Florida, 32204, United States
Life Spring Research Foundation LLC
Miami, Florida, 33130, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
West Orange Endocrinology
Ocoee, Florida, 34761, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, 34684, United States
Center for Diab,Obes & Metab
Pembroke Pines, Florida, 33024, United States
SRA Trials-Broward
Pembroke Pines, Florida, 33024, United States
Hanson Clinical Research Center
Port Charlotte, Florida, 33952, United States
Latin Clinical Trial Ctr
Tamarac, Florida, 33321, United States
Bayside Clinical Research
Tampa, Florida, 33607, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, 33401, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Centricity Research Columbus
Columbus, Georgia, 31904, United States
Physicians Research Assoc. LLC
Lawrenceville, Georgia, 30046, United States
Endocrine Research Solutions, Inc
Roswell, Georgia, 30076, United States
Rocky Mt Clin Res, LLC
Idaho Falls, Idaho, 83404-7596, United States
Northwestern University
Chicago, Illinois, 60611, United States
University Of Chicago
Chicago, Illinois, 60637-1447, United States
Endeavor Health
Skokie, Illinois, 60077, United States
Indiana Uni School of Med-Ped
Indianapolis, Indiana, 46202-5209, United States
Iowa Diabetes Research
West Des Moines, Iowa, 50266, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
Robley Rex VA Medical Center
Louisville, Kentucky, 40206, United States
MedStar Health Research Institute
Olney, Maryland, 20832, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115-5804, United States
Profound Research LLC
Clarkston, Michigan, 48346, United States
Profound Research LLC
Farmington Hills, Michigan, 48334, United States
Elite Clinical Research Center
Flint, Michigan, 48532, United States
International Diabetes Center
Minneapolis, Minnesota, 55416, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Saint Louis University
St Louis, Missouri, 63103, United States
Washington University
St Louis, Missouri, 63110, United States
QCR Network
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Palm Research Center Inc.
Las Vegas, Nevada, 89148, United States
Albuquerque Clinical Trials Inc.
Albuquerque, New Mexico, 87102, United States
AMC Community Endocrinology
Albany, New York, 12203, United States
NYC Research, Inc.
New York, New York, 10016, United States
NYU Langone Orthopedic Center
New York, New York, 10017, United States
University at Buffalo
Williamsville, New York, 14221, United States
Physicians East Endocrinology
Greenville, North Carolina, 27834, United States
Centricity Rsrch MHCity Multi
Morehead City, North Carolina, 28557, United States
Centricity Res New Bern Multispeciality
New Bern, North Carolina, 28562, United States
Accellacare of Raleigh
Raleigh, North Carolina, 27609, United States
Accellacare Wilmington
Wilmington, North Carolina, 28401, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, 44718, United States
Cleveland Clinic_Cleveland
Cleveland, Ohio, 44195, United States
The Ohio State University Medical Center
Columbus, Ohio, 43203, United States
Alliance for Multispecialty Research
Norman, Oklahoma, 73069, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
Lynn Institute - East OKC
Oklahoma City, Oklahoma, 73111, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Prisma Health Endo Spc Thy Ctr
Greenville, South Carolina, 29605, United States
Holston Medical Group_Bristol
Bristol, Tennessee, 37620, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37411, United States
MidState Endocrine Associates
Nashville, Tennessee, 37203, United States
Vanderbilt Medical Center_Nashville
Nashville, Tennessee, 37212, United States
Amarillo Medical Specialists
Amarillo, Texas, 79124, United States
Texas Diab Endo ATX N Mopac EXPR
Austin, Texas, 78731, United States
Texas Diabetes & Endocrinology
Austin, Texas, 78749, United States
Alliance Clinical Network
Dallas, Texas, 75203, United States
Thyroid Endocrinology & Diabetes PA
Dallas, Texas, 75208, United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
Research Institute Of Dallas
Dallas, Texas, 75231, United States
Precision Endo - Revival
Denton, Texas, 76210, United States
Epic Medical Research
DeSoto, Texas, 75115, United States
Frontier Medical Ctr
El Paso, Texas, 79935, United States
N. Texas Diab & Endo - Prime
Flower Mound, Texas, 75028, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132, United States
Houston Endocrinology Center
Houston, Texas, 77040, United States
The Endocrine Center
Houston, Texas, 77079, United States
Amir Ali Hassan, MD, PA
Houston, Texas, 77089, United States
RGV Endocrine Center
McAllen, Texas, 78503, United States
Tekton Research
McKinney, Texas, 75069, United States
Be Well Clinical Studies
Round Rock, Texas, 78681, United States
Texas Diabetes & Endocrinology_Round Rock
Round Rock, Texas, 78681, United States
Northeast Clinical Research of San Antonio
San Antonio, Texas, 78233, United States
Valley Diab. & Endo Comp Ctr
Weslaco, Texas, 78596, United States
Rio Clinical Trials
Ogden, Utah, 84404, United States
UVM Endocrinology
South Burlington, Vermont, 05403, United States
Rainier Clin Res Ctr Inc
Renton, Washington, 98057, United States
Prevea Health
Green Bay, Wisconsin, 54303, United States
Macquarie University - Clinical Trials Unit
Macquarie Park, New South Wales, 2109, Australia
Illawarra Diabetes Service Clinical Trials & Research Unit
Wollongong, New South Wales, 2500, Australia
Townsville University Hospital
Townsville, Queensland, 4814, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, 5046, Australia
St Vincent's Hospital Melbourne - Endocrinology & Diabetes Department
Fitzroy, Victoria, 3065, Australia
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria, 3081, Australia
The Royal Melbourne Hospital - Diabetes & Endocrinology Department
Parkville, Victoria, 3050, Australia
Centricity Research Calgary Endocrinology
Calgary, Alberta, T2H 2G4, Canada
University of Calgary
Calgary, Alberta, T2T 5C7, Canada
Vancouver General Hospital_Vancouver_0
Vancouver, British Columbia, V5Z 1M9, Canada
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, L6S 0C6, Canada
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, M9R 4E1, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, L8L 5G4, Canada
Western University Centre for Studies in Fam Med
London, Ontario, N6G 2M1, Canada
Centricity Research Toronto LMC Multispec
Toronto, Ontario, M4G 3E8, Canada
Centricity Research LMC (Toronto)
Toronto, Ontario, M9W 4L6, Canada
Ctr de recherche Clinique de Laval
Laval, Quebec, H7T 2P5, Canada
Centricity Research Mirabel
Mirabel, Quebec, J7J 2K8, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Clinique Endocrinologie OASIS.
Montreal, Quebec, H4J 1E3, Canada
Centre de Médecine Métabolique de Lanaudière
Terrebonne, Quebec, J6X 4P7, Canada
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, G1V 4W2, Canada
Diabetespraxis Mergentheim
Bad Mergentheim, 97980, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
Berlin, 13597, Germany
DSP Bochum, Diabetes- und Stoffwechselpraxis
Bochum, 44869, Germany
Uniklinik TU Dresden - Med. Klinik III
Dresden, 01307, Germany
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
Eisenach, 99817, Germany
InnoDiab Forschung GmbH
Essen, 45136, Germany
MVZ Diabeteszentrum Dr. Tews GmbH
Gelnhausen, 63571, Germany
Diabetes-Zentrum-Wilhelmsburg GbR
Hamburg, 21109, Germany
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, 22041, Germany
Wendisch - Dahl Hamburg - DZHW
Hamburg, 22607, Germany
Die Praxis am Ludwigsplatz
Ludwigshafen, 67059, Germany
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
Münster, 48153, Germany
Institut für Diabetesforschung Osnabrück
Osnabrück, 49080, Germany
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, 66386, Germany
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, 88239, Germany
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261, Poland
Formed 2 Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
Metabolica Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, 59-220, Poland
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, 85-605, Poland
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, 80-214, Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, 90-132, Poland
Zanamed Medical Clinic Sp. z o.o.
Lublin, 20-601, Poland
Reumed Sp. z o.o.
Lublin, 20-607, Poland
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spolka cywilna
Opole, 45-301, Poland
Formed 2 Sp. z o.o.
Oświęcim, 32-600, Poland
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
Piotrkow Trybunalski, 97-300, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.
Poznan, 60-354, Poland
Maciej Wiza Gaja Poradnie Lekarskie
Poznan, 61-251, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, 02-507, Poland
Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZ
Zabrze, 41-800, Poland
Etg Zamosc Sp. z o.o.
Zamość, 22-400, Poland
Centro de Endo Altagracia
Bayamón, 00959, Puerto Rico
Advanced Clinical Research LLC
Bayamón, 00961, Puerto Rico
S.C. Top Diabet Srl
Craiova, Dolj, 200515, Romania
Diabmed Dr Popescu Alexandrina SRL
Ploieşti, Prahova, 100179, Romania
CMI Dr. Pletea Noemi SRL
Bacau, 600154, Romania
Minimed S.R.L.
Bacau, 600238, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
Brasov, 500283, Romania
SC Nutrilife SRL
Bucharest, 013764, Romania
Diabs&Nutricare Srl
Bucharest, 040172, Romania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Constanța, 900591, Romania
SC Diamed Obesity SRL
Galati, 800291, Romania
S.C. Dianutrilife Medica S.R.L.
Ploieşti, 100561, Romania
Clinica Korall S.R.L. Satu Mare
Satu Mare, 440055, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245, Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Suceava, 720224, Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, 300723, Romania
DIABEDA s.r.o.
Bratislava, 831 06, Slovakia
MEDISPEKTRUM s.r.o.
Bratislava, 851 01, Slovakia
Diab - Int, s.r.o.
Bytča, 014 01, Slovakia
DIOLI s.r.o.
Košice, 040 01, Slovakia
HUMAN-CARE, s.r.o.
Košice, 040 01, Slovakia
DIADAN, s.r.o. Kosice
Košice, 04011, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2025
First Posted
July 22, 2025
Study Start
August 11, 2025
Primary Completion (Estimated)
January 25, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com