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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

NCT07076199 · Novo Nordisk A/S
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Official title
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
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Study design
Enrollment target: 877 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-11
Estimated completion: 2027-03-01
Last updated: 2026-04-06
Interventions
Drug: Insulin icodecDrug: Insulin glargineDrug: Insulin aspart
Primary outcomes
  • Change in glycosylated haemoglobin (HbA1c) (From baseline (week 0) to week 26)
Sponsor
Novo Nordisk A/S · industry
Contacts & investigators
ContactNovo Nordisk · contact · clinicaltrials@novonordisk.com · (+1) 866-867-7178
InvestigatorClinical Transparency (dept. 2834) · study_director, Novo Nordisk A/S
All locations (193)
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Concord, California, United States
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Escondido, California, United States
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Fresno, California, United States
Providence Medical FoundationRecruiting
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Scripps Whittier Diabetes InstRecruiting
La Jolla, California, United States
Loma Linda University Faculty Medical ClinicsRecruiting
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Pomona, California, United States
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Center for Endocrine DM and Metabolic DisordersRecruiting
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Walnut Creek, California, United States
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Golden, Colorado, United States
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Hollywood, Florida, United States
Northeast Research InstituteNot Yet Recruiting
Jacksonville, Florida, United States
Life Spring Research Foundation LLCNot Yet Recruiting
Miami, Florida, United States
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New Port Richey, Florida, United States
West Orange EndocrinologyRecruiting
Ocoee, Florida, United States
Suncoast Clinical Research, Inc.Active Not Recruiting
Palm Harbor, Florida, United States
Center for Diab,Obes & MetabRecruiting
Pembroke Pines, Florida, United States
SRA Trials-BrowardRecruiting
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Hanson Clinical Research CenterRecruiting
Port Charlotte, Florida, United States
Latin Clinical Trial CtrRecruiting
Tamarac, Florida, United States
Bayside Clinical ResearchRecruiting
Tampa, Florida, United States
Metabolic Research Institute IncRecruiting
West Palm Beach, Florida, United States
Atlanta Diabetes AssociatesRecruiting
Atlanta, Georgia, United States
Centricity Research ColumbusRecruiting
Columbus, Georgia, United States
Physicians Research Assoc. LLCRecruiting
Lawrenceville, Georgia, United States
Endocrine Research Solutions, IncRecruiting
Roswell, Georgia, United States
Rocky Mt Clin Res, LLCRecruiting
Idaho Falls, Idaho, United States
Northwestern UniversityCompleted
Chicago, Illinois, United States
University Of ChicagoRecruiting
Chicago, Illinois, United States
Endeavor HealthRecruiting
Skokie, Illinois, United States
Indiana Uni School of Med-PedCompleted
Indianapolis, Indiana, United States
Iowa Diabetes ResearchRecruiting
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes & EndocrinologyRecruiting
Topeka, Kansas, United States
Robley Rex VA Medical CenterNot Yet Recruiting
Louisville, Kentucky, United States
MedStar Health Research InstituteRecruiting
Olney, Maryland, United States
Brigham & Women's HospitalRecruiting
Boston, Massachusetts, United States
Profound Research LLCRecruiting
Clarkston, Michigan, United States
Profound Research LLCRecruiting
Farmington Hills, Michigan, United States
Elite Clinical Research CenterRecruiting
Flint, Michigan, United States
International Diabetes CenterRecruiting
Minneapolis, Minnesota, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Saint Louis UniversityCompleted
St Louis, Missouri, United States
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St Louis, Missouri, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
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University of Nebraska Medical CenterRecruiting
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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NYC Research, Inc.Recruiting
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University at BuffaloRecruiting
Williamsville, New York, United States
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Centricity Rsrch MHCity MultiRecruiting
Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Cleveland Clinic_ClevelandRecruiting
Cleveland, Ohio, United States
The Ohio State University Medical CenterRecruiting
Columbus, Ohio, United States
Alliance for Multispecialty ResearchRecruiting
Norman, Oklahoma, United States
Lynn Institute of NormanRecruiting
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Lynn Institute - East OKCRecruiting
Oklahoma City, Oklahoma, United States
Thomas Jefferson University HospitalRecruiting
Philadelphia, Pennsylvania, United States
Prisma Health Endo Spc Thy CtrRecruiting
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Bristol, Tennessee, United States
University Diabetes & Endocrine ConsultantsRecruiting
Chattanooga, Tennessee, United States
MidState Endocrine AssociatesRecruiting
Nashville, Tennessee, United States
Vanderbilt Medical Center_NashvilleRecruiting
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Amarillo Medical SpecialistsRecruiting
Amarillo, Texas, United States
Texas Diab Endo ATX N Mopac EXPRRecruiting
Austin, Texas, United States
Texas Diabetes & EndocrinologyRecruiting
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Alliance Clinical NetworkRecruiting
Dallas, Texas, United States
Thyroid Endocrinology & Diabetes PARecruiting
Dallas, Texas, United States
Velocity Clinical Res-DallasRecruiting
Dallas, Texas, United States
North Texas Endocrine CenterCompleted
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Research Institute Of DallasRecruiting
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Precision Endo - RevivalRecruiting
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Epic Medical ResearchRecruiting
DeSoto, Texas, United States
Frontier Medical CtrRecruiting
El Paso, Texas, United States
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Houston Endocrinology CenterCompleted
Houston, Texas, United States
The Endocrine CenterRecruiting
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Amir Ali Hassan, MD, PARecruiting
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RGV Endocrine CenterRecruiting
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Tekton ResearchRecruiting
McKinney, Texas, United States
Be Well Clinical StudiesRecruiting
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Texas Diabetes & Endocrinology_Round RockRecruiting
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Northeast Clinical Research of San AntonioRecruiting
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Valley Diab. & Endo Comp CtrRecruiting
Weslaco, Texas, United States
Rio Clinical TrialsRecruiting
Ogden, Utah, United States
UVM EndocrinologyCompleted
South Burlington, Vermont, United States
Rainier Clin Res Ctr IncRecruiting
Renton, Washington, United States
Prevea HealthRecruiting
Green Bay, Wisconsin, United States
Macquarie University - Clinical Trials UnitRecruiting
Macquarie Park, New South Wales, Australia
Illawarra Diabetes Service Clinical Trials & Research UnitRecruiting
Wollongong, New South Wales, Australia
Townsville University HospitalRecruiting
Townsville, Queensland, Australia
Southern Adelaide Diabetes & Endocrine ServicesRecruiting
Oaklands Park, South Australia, Australia
St Vincent's Hospital Melbourne - Endocrinology & Diabetes DepartmentRecruiting
Fitzroy, Victoria, Australia
Austin Health, Metabolic Disorders CentreRecruiting
Heidelberg Heights, Victoria, Australia
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Parkville, Victoria, Australia
Centricity Research Calgary EndocrinologyRecruiting
Calgary, Alberta, Canada
University of CalgaryCompleted
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Vancouver General Hospital_Vancouver_0Not Yet Recruiting
Vancouver, British Columbia, Canada
Winnipeg ClinicRecruiting
Winnipeg, Manitoba, Canada
Nova Scotia Health AuthorityRecruiting
Halifax, Nova Scotia, Canada
Centricity Research Brampton EndocrinologyRecruiting
Brampton, Ontario, Canada
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Etobicoke, Ontario, Canada
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Western University Centre for Studies in Fam MedRecruiting
London, Ontario, Canada
Centricity Research Toronto LMC MultispecRecruiting
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Laval, Quebec, Canada
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Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.Recruiting
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Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.Recruiting
Poznan, Poland
Gaja Poradnie LekarskieCompleted
Poznan, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiARecruiting
Warsaw, Poland
Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZRecruiting
Zabrze, Poland
Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZNot Yet Recruiting
Zabrze, Poland
Etg Zamosc Sp. z o.o.Recruiting
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Advanced Clinical Research LLCRecruiting
Bayamón, Puerto Rico
S.C. Top Diabet SrlRecruiting
Craiova, Dolj, Romania
Diabmed Dr Popescu Alexandrina SRLRecruiting
Ploieşti, Prahova, Romania
CMI Dr. Pletea Noemi SRLRecruiting
Bacau, Romania
Minimed S.R.L.Recruiting
Bacau, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu NeomedRecruiting
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SC Nutrilife SRLRecruiting
Bucharest, Romania
Diabs&Nutricare SrlNot Yet Recruiting
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Constanța, Romania
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Galati, Romania
S.C. Dianutrilife Medica S.R.L.Recruiting
Ploieşti, Romania
Clinica Korall S.R.L. Satu MareRecruiting
Satu Mare, Romania
Spitalul Clinic Judetean de Urgenta SibiuRecruiting
Sibiu, Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou SuceavaRecruiting
Suceava, Romania
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MEDISPEKTRUM s.r.o.Recruiting
Bratislava, Slovakia
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DIOLI s.r.o.Recruiting
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HUMAN-CARE, s.r.o.Recruiting
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DIADAN, s.r.o. KosiceRecruiting
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