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
NCT ID: NCT07076199
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
877 participants
INTERVENTIONAL
2025-08-11
2026-12-28
Brief Summary
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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 aspart
Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
Insulin icodec
Insulin icodec will be administered as subcutaneous injection
Insulin aspart
Insulin aspart will be administered as a subcutaneous injection.
Insulin glargine+ insulin aspart
Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
Insulin glargine
Insulin glargine will be administered as subcutaneous injection.
Insulin aspart
Insulin aspart will be administered as a subcutaneous injection.
Interventions
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Insulin icodec
Insulin icodec will be administered as subcutaneous injection
Insulin glargine
Insulin glargine will be administered as subcutaneous injection.
Insulin aspart
Insulin aspart will be administered as a subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
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 (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Cullman Clinical Trials
Cullman, Alabama, United States
John Muir Health
Concord, California, United States
Headlands Research California, LLC
Escondido, California, United States
Clinical Res of Central Ca
Fresno, California, United States
Providence Medical Foundation
Fullerton, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Loma Linda University Faculty Medical Clinics
Loma Linda, California, United States
Loma Linda University Faculty Medical Clinics
Loma Linda, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Pasadena Clinical Trials
Pasadena, California, United States
WestenU Health
Pomona, California, United States
WestenU Health
Pomona, California, United States
Alliance Clinical Network
San Diego, California, United States
Mills Health Center
San Mateo, California, United States
Center for Endocrine DM and Metabolic Disorders
Santa Clarita, California, United States
University Clin Investigators
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, United States
Optumcare Clinical Trials,LLC-Golden
Golden, Colorado, United States
Northeast Research Institute
Fleming Island, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, United States
SRA Trials-Broward
Pembroke Pines, Florida, United States
Hanson Clinical Research Center
Port Charlotte, Florida, United States
Latin Clinical Trial Ctr
Tamarac, Florida, United States
Bayside Clinical Research
Tampa, Florida, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Centricity Research Columbus
Columbus, Georgia, United States
Physicians Research Assoc. LLC
Lawrenceville, Georgia, United States
Endocrine Research Solutions, Inc
Roswell, Georgia, United States
Rocky Mt Clin Res, LLC
Idaho Falls, Idaho, United States
Northwestern University
Chicago, Illinois, United States
University Of Chicago
Chicago, Illinois, United States
Endeavor Health
Skokie, Illinois, United States
Indiana Uni School of Med-Ped
Indianapolis, Indiana, United States
Iowa Diabetes Research
Des Moines, Iowa, United States
Cotton O’Neil Diabetes & Endocrinology
Topeka, Kansas, United States
Robley Rex VA Medical Center
Louisville, Kentucky, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Profound Research LLC
Clarkston, Michigan, United States
Elite Clinical Research Center
Flint, Michigan, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
QCR Network
Omaha, Nebraska, United States
Palm Research Center Inc.
Las Vegas, Nevada, United States
Albuquerque Clinical Trials Inc.
Albuquerque, New Mexico, United States
AMC Community Endocrinology
Albany, New York, United States
NYC Research, Inc.
New York, New York, United States
NYU Langone Health
New York, New York, United States
University at Buffalo
Williamsville, New York, United States
Physicians East Endocrinology
Greenville, North Carolina, United States
Lucas Research Inc.
Morehead City, North Carolina, United States
Centricity Res New Bern
New Bern, North Carolina, United States
Accellacare Wilmington
Wilmington, North Carolina, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, United States
Cleveland Clinic_Cleveland
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Alliance for Multispecialty Research
Norman, Oklahoma, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Lynn Institute - East OKC
Oklahoma City, Oklahoma, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Prisma Health Endo Spc Thy Ctr
Greenville, South Carolina, United States
Holston Medical Group_Bristol
Bristol, Tennessee, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States
MidState Endocrine Associates
Nashville, Tennessee, United States
Vanderbilt Medical Center_Nashville
Nashville, Tennessee, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Texas Diab Endo ATX N Mopac EXPR
Austin, Texas, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
Alliance Clinical Network
Dallas, Texas, United States
Thyroid Endocrinology & Diabetes PA
Dallas, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Research Institute Of Dallas
Dallas, Texas, United States
Precision Endo - Revival
Denton, Texas, United States
Epic Medical Research
DeSoto, Texas, United States
Frontier Medical Ctr
El Paso, Texas, United States
N. Texas Diab & Endo - Prime
Flower Mound, Texas, United States
N. Texas Diab & Endo - Prime
Flower Mound, Texas, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, United States
Houston Endocrinology Center
Houston, Texas, United States
The Endocrine Center
Houston, Texas, United States
Amir Ali Hassan, MD, PA
Houston, Texas, United States
RGV Endocrine Center
McAllen, Texas, United States
Tekton Research
McKinney, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States
Texas Diabetes & Endocrinology_Round Rock
Round Rock, Texas, United States
Northeast Clinical Research of San Antonio
San Antonio, Texas, United States
Valley Diab. & Endo Comp Ctr
Weslaco, Texas, United States
Rio Clinical Trials
Ogden, Utah, United States
UVM Endocrinology
South Burlington, Vermont, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Prevea Health
Green Bay, Wisconsin, United States
Macquarie University
Macquarie Park, New South Wales, Australia
Illawarra Diabetes Service Clinical Trials & Research Unit
Wollongong, New South Wales, Australia
Townsville University Hospital
Townsville, Queensland, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, Australia
St Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Centricity Research Calgary Endocrinology
Calgary, Alberta, Canada
University of Calgary
Calgary, Alberta, Canada
Vancouver General Hospital_Vancouver_0
Vancouver, British Columbia, Canada
Winnipeg Clinic
Winnipeg, Manitoba, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, Canada
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Western University Centre for Studies in Fam Med
London, Ontario, Canada
Centricity Research Toronto LMC Multispec
Toronto, Ontario, Canada
Centricity Research LMC
Toronto, Ontario, Canada
Ctr de rech Clin de Laval
Laval, Quebec, Canada
Ctr de recherche Clinique de Laval
Laval, Quebec, Canada
Centricity Research Mirabel
Mirabel, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Clinique Endocrinologie OASIS.
Montreal, Quebec, Canada
Clin des Mal Lipid de Quebec
Québec, Quebec, Canada
Centre de Médecine Métabolique de Lanaudière
Terrebonne, Quebec, Canada
Centre de Médecine Métabolique de Lanaudière
Terrebonne, Quebec, Canada
Diabetespraxis Mergentheim
Bad Mergentheim, , Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, , Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
Berlin, , Germany
DSP Bochum, Diabetes- und Stoffwechselpraxis
Bochum, , Germany
Uniklinik TU Dresden - Med. Klinik III
Dresden, , Germany
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
Eisenach, , Germany
InnoDiab Forschung GmbH
Essen, , Germany
MVZ Diabeteszentrum Dr. Tews GmbH
Gelnhausen, , Germany
Diabetes-Zentrum-Wilhelmsburg GbR
Hamburg, , Germany
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, , Germany
Wendisch/Dahl Hamburg (DZHW)
Hamburg, , Germany
Die Praxis am Ludwigsplatz
Ludwigshafen, , Germany
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
Münster, , Germany
Institut für Diabetesforschung Osnabrück
Osnabrück, , Germany
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, , Germany
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, , Germany
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, Poland
Formed 2 Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, Poland
Metabolica Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, Poland
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, Poland
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, , Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, , Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, , Poland
Zanamed Medical Clinic Sp. z o.o.
Lublin, , Poland
Zanamed Medical Clinic Sp. z o.o.
Lublin, , Poland
Reumed Sp. z o.o.
Lublin, , Poland
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spolka cywilna
Opole, , Poland
Formed 2 Sp. z o.o.
Oświęcim, , Poland
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
Piotrkow Trybunalski, , Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.
Poznan, , Poland
Gaja Poradnie Lekarskie
Poznan, , Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, , Poland
Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZ
Zabrze, , Poland
Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZ
Zabrze, , Poland
Etg Zamosc Sp. z o.o.
Zamość, , Poland
Centro de Endo Altagracia
Bayamón, , Puerto Rico
Advanced Clinical Research LLC
Bayamón, , Puerto Rico
S.C. Top Diabet Srl
Craiova, Dolj, Romania
Diabmed Dr Popescu Alexandrina SRL
Ploieşti, Prahova, Romania
CMI Dr. Pletea Noemi SRL
Bacau, , Romania
Minimed S.R.L.
Bacau, , Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
Brasov, , Romania
SC Nutrilife SRL
Bucharest, , Romania
Diabs&Nutricare Srl
Bucharest, , Romania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Constanța, , Romania
SC Diamed Obesity SRL
Galati, , Romania
S.C. Dianutrilife Medica S.R.L.
Ploieşti, , Romania
Clinica Korall S.R.L. Satu Mare
Satu Mare, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, , Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Suceava, , Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, , Romania
DIABEDA s.r.o.
Bratislava, , Slovakia
MEDISPEKTRUM s.r.o.
Bratislava, , Slovakia
Diab - Int, s.r.o.
Bytča, , Slovakia
DIOLI s.r.o.
Košice, , Slovakia
HUMAN-CARE, s.r.o.
Košice, , Slovakia
DIADAN, s.r.o. Kosice
Košice, , Slovakia
Countries
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Central Contacts
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Other Identifiers
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U1111-1310-7017
Identifier Type: OTHER
Identifier Source: secondary_id
2024-519945-31
Identifier Type: OTHER
Identifier Source: secondary_id
NN1436-8182
Identifier Type: -
Identifier Source: org_study_id
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