TrialPath
Recruiting

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
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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: 2026-06-29
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 (196)
Cullman Clinical TrialsCompleted
Cullman, Alabama, United States
John Muir HealthRecruiting
Concord, California, United States
Headlands Research California, LLCCompleted
Escondido, California, United States
Clinical Res of Central CaRecruiting
Fresno, California, United States
Providence Medical FoundationActive Not Recruiting
Fullerton, California, United States
Scripps Whittier Diabetes InstCompleted
La Jolla, California, United States
Loma Linda University Faculty Medical ClinicsRecruiting
Loma Linda, California, United States
Loma Linda University Faculty Medical ClinicsNot Yet Recruiting
Loma Linda, California, United States
Pacific Clinical StudiesActive Not Recruiting
Los Alamitos, California, United States
Los Angeles Institute for Metabolic ResearchActive Not Recruiting
Los Angeles, California, United States
Pasadena Clinical TrialsRecruiting
Pasadena, California, United States
WestenU HealthCompleted
Pomona, California, United States
WestenU HealthWithdrawn
Pomona, California, United States
Alliance Clinical NetworkCompleted
San Diego, California, United States
Mills Health CenterRecruiting
San Mateo, California, United States
Center for Endocrine DM and Metabolic DisordersRecruiting
Santa Clarita, California, United States
University Clin InvestigatorsCompleted
Tustin, California, United States
Diablo Clinical Research, Inc.Recruiting
Walnut Creek, California, United States
Denver Endocrinology Diabetes and Thyroid CenterNot Yet Recruiting
Englewood, Colorado, United States
Denver Endocrinology Diabetes and Thyroid CenterActive Not Recruiting
Englewood, Colorado, United States
Optumcare Clinical Trials,LLC-GoldenCompleted
Golden, Colorado, United States
Northeast Research InstituteRecruiting
Fleming Island, Florida, United States
Encore Medical Research LLCActive Not Recruiting
Hollywood, Florida, United States
Northeast Research InstituteCompleted
Jacksonville, Florida, United States
Life Spring Research Foundation LLCCompleted
Miami, Florida, United States
Suncoast Clinical Research, Inc.Active Not Recruiting
New Port Richey, Florida, United States
West Orange EndocrinologyActive Not Recruiting
Ocoee, Florida, United States
Suncoast Clinical Research, Inc.Completed
Palm Harbor, Florida, United States
Center for Diab,Obes & MetabRecruiting
Pembroke Pines, Florida, United States
SRA Trials-BrowardRecruiting
Pembroke Pines, Florida, United States
Hanson Clinical Research CenterRecruiting
Port Charlotte, Florida, United States
Latin Clinical Trial CtrRecruiting
Tamarac, Florida, United States
Bayside Clinical ResearchCompleted
Tampa, Florida, United States
Metabolic Research Institute IncActive Not Recruiting
West Palm Beach, Florida, United States
Atlanta Diabetes AssociatesActive Not Recruiting
Atlanta, Georgia, United States
Centricity Research ColumbusRecruiting
Columbus, Georgia, United States
Physicians Research Assoc. LLCActive Not Recruiting
Lawrenceville, Georgia, United States
Endocrine Research Solutions, IncActive Not Recruiting
Roswell, Georgia, United States
Rocky Mt Clin Res, LLCActive Not Recruiting
Idaho Falls, Idaho, United States
Northwestern UniversityCompleted
Chicago, Illinois, United States
University Of ChicagoActive Not Recruiting
Chicago, Illinois, United States
Endeavor HealthActive Not Recruiting
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 & EndocrinologyActive Not Recruiting
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 LLCActive Not Recruiting
Clarkston, Michigan, United States
Profound Research LLCRecruiting
Farmington Hills, Michigan, United States
Elite Clinical Research CenterCompleted
Flint, Michigan, United States
International Diabetes CenterActive Not Recruiting
Minneapolis, Minnesota, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Saint Louis UniversityCompleted
St Louis, Missouri, United States
Saint Louis UniversityNot Yet Recruiting
St Louis, Missouri, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Washington UniversityNot Yet Recruiting
St Louis, Missouri, United States
QCR NetworkRecruiting
Omaha, Nebraska, United States
University of Nebraska Medical CenterActive Not Recruiting
Omaha, Nebraska, United States
Palm Research Center Inc.Recruiting
Las Vegas, Nevada, United States
Albuquerque Clinical Trials Inc.Recruiting
Albuquerque, New Mexico, United States
AMC Community EndocrinologyActive Not Recruiting
Albany, New York, United States
NYC Research, Inc.Recruiting
New York, New York, United States
NYU Langone Orthopedic CenterRecruiting
New York, New York, United States
University at BuffaloRecruiting
Williamsville, New York, United States
Physicians East EndocrinologyActive Not Recruiting
Greenville, North Carolina, United States
Centricity Rsrch MHCity MultiActive Not Recruiting
Morehead City, North Carolina, United States
Centricity Res New Bern MultispecialityCompleted
New Bern, North Carolina, United States
Accellacare of RaleighRecruiting
Raleigh, North Carolina, United States
Accellacare WilmingtonActive Not Recruiting
Wilmington, North Carolina, United States
Diab & Endo Assoc of Stark CoActive Not Recruiting
Canton, Ohio, United States
Cleveland Clinic_ClevelandActive Not Recruiting
Cleveland, Ohio, United States
The Ohio State University Medical CenterActive Not Recruiting
Columbus, Ohio, United States
Alliance for Multispecialty ResearchActive Not Recruiting
Norman, Oklahoma, United States
Lynn Institute of NormanActive Not Recruiting
Norman, Oklahoma, United States
Lynn Institute - East OKCCompleted
Oklahoma City, Oklahoma, United States
Lynn Institute - East OKCRecruiting
Oklahoma City, Oklahoma, United States
Thomas Jefferson University HospitalActive Not Recruiting
Philadelphia, Pennsylvania, United States
Prisma Health Endo Spc Thy CtrActive Not Recruiting
Greenville, South Carolina, United States
Holston Medical Group_BristolCompleted
Bristol, Tennessee, United States
University Diabetes & Endocrine ConsultantsActive Not Recruiting
Chattanooga, Tennessee, United States
MidState Endocrine AssociatesActive Not Recruiting
Nashville, Tennessee, United States
Vanderbilt Medical Center_NashvilleRecruiting
Nashville, Tennessee, United States
Amarillo Medical SpecialistsActive Not Recruiting
Amarillo, Texas, United States
Texas Diab Endo ATX N Mopac EXPRRecruiting
Austin, Texas, United States
Texas Diabetes & EndocrinologyActive Not Recruiting
Austin, Texas, United States
Alliance Clinical NetworkRecruiting
Dallas, Texas, United States
Thyroid Endocrinology & Diabetes PACompleted
Dallas, Texas, United States
Velocity Clinical Res-DallasActive Not Recruiting
Dallas, Texas, United States
Velocity Clinical Res-DallasRecruiting
Dallas, Texas, United States
North Texas Endocrine CenterCompleted
Dallas, Texas, United States
Research Institute Of DallasRecruiting
Dallas, Texas, United States
Precision Endo - RevivalRecruiting
Denton, Texas, United States
Epic Medical ResearchRecruiting
DeSoto, Texas, United States
Frontier Medical CtrRecruiting
El Paso, Texas, United States
N. Texas Diab & Endo - PrimeCompleted
Flower Mound, Texas, United States
N. Texas Diab & Endo - PrimeWithdrawn
Flower Mound, Texas, United States
Diabetes and Thyroid Center of Fort WorthActive Not Recruiting
Fort Worth, Texas, United States
Houston Endocrinology CenterCompleted
Houston, Texas, United States
The Endocrine CenterActive Not Recruiting
Houston, Texas, United States
Amir Ali Hassan, MD, PARecruiting
Houston, Texas, United States
RGV Endocrine CenterActive Not Recruiting
McAllen, Texas, United States
Tekton ResearchActive Not Recruiting
McKinney, Texas, United States
Tekton ResearchRecruiting
McKinney, Texas, United States
Be Well Clinical StudiesActive Not Recruiting
Round Rock, Texas, United States
Texas Diabetes & Endocrinology_Round RockRecruiting
Round Rock, Texas, United States
Northeast Clinical Research of San AntonioActive Not Recruiting
San Antonio, Texas, United States
Valley Diab. & Endo Comp CtrActive Not Recruiting
Weslaco, Texas, United States
Rio Clinical TrialsRecruiting
Ogden, Utah, United States
UVM EndocrinologyCompleted
South Burlington, Vermont, United States
Rainier Clin Res Ctr IncActive Not Recruiting
Renton, Washington, United States
Prevea HealthActive Not Recruiting
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
The Royal Melbourne Hospital - Diabetes & Endocrinology DepartmentRecruiting
Parkville, Victoria, Australia
Centricity Research Calgary EndocrinologyRecruiting
Calgary, Alberta, Canada
University of CalgaryCompleted
Calgary, Alberta, Canada
Vancouver General Hospital_Vancouver_0Recruiting
Vancouver, British Columbia, Canada
Winnipeg ClinicRecruiting
Winnipeg, Manitoba, Canada
Nova Scotia Health AuthorityRecruiting
Halifax, Nova Scotia, Canada
Centricity Research Brampton EndocrinologyRecruiting
Brampton, Ontario, Canada
Centricity Research Etobicoke EndocrinologyRecruiting
Etobicoke, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)Recruiting
Hamilton, Ontario, Canada
Western University Centre for Studies in Fam MedRecruiting
London, Ontario, Canada
Centricity Research Toronto LMC MultispecRecruiting
Toronto, Ontario, Canada
Centricity Research LMC (Toronto)Completed
Toronto, Ontario, Canada
Ctr de rech Clin de LavalWithdrawn
Laval, Quebec, Canada
Ctr de recherche Clinique de LavalCompleted
Laval, Quebec, Canada
Centricity Research MirabelRecruiting
Mirabel, Quebec, Canada
McGill University Health CentreNot Yet Recruiting
Montreal, Quebec, Canada
Clinique Endocrinologie OASIS.Completed
Montreal, Quebec, Canada
Centre de Médecine Métabolique de LanaudièreRecruiting
Terrebonne, Quebec, Canada
Centre de Médecine Métabolique de LanaudièreNot Yet Recruiting
Terrebonne, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Inc.Recruiting
Québec, Canada
Diabetespraxis MergentheimCompleted
Bad Mergentheim, Germany
Herz- und Diabeteszentrum NRW - Bad OeynhausenActive Not Recruiting
Bad Oeynhausen, Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbRActive Not Recruiting
Berlin, Germany
DSP Bochum, Diabetes- und StoffwechselpraxisActive Not Recruiting
Bochum, Germany
Uniklinik TU Dresden - Med. Klinik IIIActive Not Recruiting
Dresden, Germany
Praxis für Diabetologie, Angiologie und Innere Medizin EisenachNot Yet Recruiting
Eisenach, Germany
InnoDiab Forschung GmbHActive Not Recruiting
Essen, Germany
MVZ Diabeteszentrum Dr. Tews GmbHCompleted
Gelnhausen, Germany
Diabetes-Zentrum-Wilhelmsburg GbRActive Not Recruiting
Hamburg, Germany
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbRActive Not Recruiting
Hamburg, Germany
Wendisch - Dahl Hamburg - DZHWActive Not Recruiting
Hamburg, Germany
Die Praxis am LudwigsplatzActive Not Recruiting
Ludwigshafen, Germany
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und ErnährungsmedizinActive Not Recruiting
Münster, Germany
Institut für Diabetesforschung OsnabrückActive Not Recruiting
Osnabrück, Germany
Zentrum für klinische Studien Alexander SegnerActive Not Recruiting
Saint Ingbert-Oberwürzbach, Germany
Zentrum für klinische Studien Allgäu OberschwabenCompleted
Wangen, Germany
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-METRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Formed 2 Sp. z o.o.Recruiting
Oświęcim, Lesser Poland Voivodeship, Poland
Metabolica Sp. z o.o.Recruiting
Tarnów, Lesser Poland Voivodeship, Poland
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.Recruiting
Legnica, Lower Silesian Voivodeship, Poland
Centrum Medyczne Intercor Sp. z o.o.Recruiting
Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne (UCK)Not Yet Recruiting
Gdansk, Poland
Gabinet Lekarski Malgorzata Saryusz-WolskaRecruiting
Lodz, Poland
Gabinet Lekarski Malgorzata Saryusz-WolskaNot Yet Recruiting
Lodz, Poland
Zanamed Medical Clinic Sp. z o.o.Recruiting
Lublin, Poland
Zanamed Medical Clinic Sp. z o.o.Not Yet Recruiting
Lublin, Poland
Reumed Sp. z o.o.Recruiting
Lublin, Poland
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spolka cywilnaNot Yet Recruiting
Opole, Poland
Formed 2 Sp. z o.o.Not Yet Recruiting
Oświęcim, Poland
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.Recruiting
Piotrkow Trybunalski, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.Recruiting
Poznan, Poland
Maciej Wiza 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
Zamość, Poland
Centro de Endo AltagraciaActive Not Recruiting
Bayamón, Puerto Rico
Advanced Clinical Research LLCRecruiting
Bayamón, Puerto Rico
S.C. Top Diabet SrlActive Not Recruiting
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 NeomedActive Not Recruiting
Brasov, Romania
SC Nutrilife SRLActive Not Recruiting
Bucharest, Romania
Diabs&Nutricare SrlNot Yet Recruiting
Bucharest, Romania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei ConstantaActive Not Recruiting
Constanța, Romania
SC Diamed Obesity SRLCompleted
Galati, Romania
S.C. Dianutrilife Medica S.R.L.Active Not Recruiting
Ploieşti, Romania
Clinica Korall S.R.L. Satu MareActive Not Recruiting
Satu Mare, Romania
Spitalul Clinic Judetean de Urgenta SibiuActive Not Recruiting
Sibiu, Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou SuceavaRecruiting
Suceava, Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu TimisoaraRecruiting
Timișoara, Romania
DIABEDA s.r.o.Completed
Bratislava, Slovakia
MEDISPEKTRUM s.r.o.Active Not Recruiting
Bratislava, Slovakia
Diab - Int, s.r.o.Active Not Recruiting
Bytča, Slovakia
DIOLI s.r.o.Active Not Recruiting
Košice, Slovakia
HUMAN-CARE, s.r.o.Recruiting
Košice, Slovakia
DIADAN, s.r.o. KosiceActive Not Recruiting
Košice, Slovakia
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 · TrialPath