Weekly insulin shot could replace daily shots for type 1 diabetes

NCT ID NCT07076199

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 6 times

Summary

This study compares a new insulin that is injected once a week (insulin icodec) to a standard daily insulin (insulin glargine) in about 877 adults with type 1 diabetes. The goal is to see if the weekly insulin controls blood sugar just as well as the daily one. Participants will also use a fast-acting insulin at meals. The study lasts about 8.5 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 877 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1

Contacts and locations

Locations

AMC Community Endocrinology

Albany, New York, 12203, United States
Accellacare Wilmington

Wilmington, North Carolina, 28401, United States
Accellacare of Raleigh

Raleigh, North Carolina, 27609, United States
Advanced Clinical Research LLC

Bayamón, 00961, Puerto Rico
Albuquerque Clinical Trials Inc.

Albuquerque, New Mexico, 87102, United States
Alliance Clinical Network

San Diego, California, 92120, United States
Alliance Clinical Network

Dallas, Texas, 75203, United States
Alliance for Multispecialty Research

Norman, Oklahoma, 73069, United States
Amarillo Medical Specialists

Amarillo, Texas, 79124, United States
Amir Ali Hassan, MD, PA

Houston, Texas, 77089, United States
Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States
Austin Health, Metabolic Disorders Centre

Heidelberg Heights, Victoria, 3081, Australia
Bayside Clinical Research

Tampa, Florida, 33607, United States
Be Well Clinical Studies

Round Rock, Texas, 78681, United States
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.

Legnica, Lower Silesian Voivodeship, 59-220, Poland
Brigham & Women's Hospital

Boston, Massachusetts, 02115-5804, United States
CMI Dr. Pletea Noemi SRL

Bacau, 600154, Romania
Center for Diab,Obes & Metab

Pembroke Pines, Florida, 33024, United States
Center for Endocrine DM and Metabolic Disorders

Santa Clarita, California, 91321, United States
Centre de Médecine Métabolique de Lanaudière

Terrebonne, Quebec, J6X 4P7, Canada
Centricity Res New Bern Multispeciality

New Bern, North Carolina, 28562, United States
Centricity Research Brampton Endocrinology

Brampton, Ontario, L6S 0C6, Canada
Centricity Research Calgary Endocrinology

Calgary, Alberta, T2H 2G4, Canada
Centricity Research Columbus

Columbus, Georgia, 31904, United States
Centricity Research Etobicoke Endocrinology

Etobicoke, Ontario, M9R 4E1, Canada
Centricity Research LMC (Toronto)

Toronto, Ontario, M9W 4L6, Canada
Centricity Research Mirabel

Mirabel, Quebec, J7J 2K8, Canada
Centricity Research Toronto LMC Multispec

Toronto, Ontario, M4G 3E8, Canada
Centricity Rsrch MHCity Multi

Morehead City, North Carolina, 28557, United States
Centro de Endo Altagracia

Bayamón, 00959, Puerto Rico
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed

Brasov, 500283, Romania
Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, 85-605, Poland
Cleveland Clinic_Cleveland

Cleveland, Ohio, 44195, United States
Clinica Korall S.R.L. Satu Mare

Satu Mare, 440055, Romania
Clinical Res of Central Ca

Fresno, California, 93704, United States
Clinique Endocrinologie OASIS.

Montreal, Quebec, H4J 1E3, Canada
Clinique des Maladies Lipidiques de Quebec Inc.

Québec, G1V 4W2, Canada
Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, 66606, United States
Ctr de recherche Clinique de Laval

Laval, Quebec, H7T 2P5, Canada
Cullman Clinical Trials

Cullman, Alabama, 35055, United States
DIABEDA s.r.o.

Bratislava, 831 06, Slovakia
DIADAN, s.r.o. Kosice

Košice, 04011, Slovakia
DIOLI s.r.o.

Košice, 040 01, Slovakia
DSP Bochum, Diabetes- und Stoffwechselpraxis

Bochum, 44869, Germany
Denver Endocrinology Diabetes and Thyroid Center

Englewood, Colorado, 80113, United States
Diab & Endo Assoc of Stark Co

Canton, Ohio, 44718, United States
Diab - Int, s.r.o.

Bytča, 014 01, Slovakia
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR

Hamburg, 22041, Germany
Diabetes and Thyroid Center of Fort Worth

Fort Worth, Texas, 76132, United States
Diabetes-Zentrum-Wilhelmsburg GbR

Hamburg, 21109, Germany
Diabetespraxis Mergentheim

Bad Mergentheim, 97980, Germany
Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States
Diabmed Dr Popescu Alexandrina SRL

Ploieşti, Prahova, 100179, Romania
Diabs&Nutricare Srl

Bucharest, 040172, Romania
Die Praxis am Ludwigsplatz

Ludwigshafen, 67059, Germany
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spolka cywilna

Opole, 45-301, Poland
Elite Clinical Research Center

Flint, Michigan, 48532, United States
Encore Medical Research LLC

Hollywood, Florida, 33024, United States
Endeavor Health

Skokie, Illinois, 60077, United States
Endocrine Research Solutions, Inc

Roswell, Georgia, 30076, United States
Epic Medical Research

DeSoto, Texas, 75115, United States
Etg Zamosc Sp. z o.o.

Zamość, 22-400, Poland
Formed 2 Sp. z o.o.

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
Formed 2 Sp. z o.o.

Oświęcim, 32-600, Poland
Frontier Medical Ctr

El Paso, Texas, 79935, United States
Gabinet Lekarski Malgorzata Saryusz-Wolska

Lodz, 90-132, Poland
HUMAN-CARE, s.r.o.

Košice, 040 01, Slovakia
Hanson Clinical Research Center

Port Charlotte, Florida, 33952, United States
Headlands Research California, LLC

Escondido, California, 92025, United States
Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, 32545, Germany
Holston Medical Group_Bristol

Bristol, Tennessee, 37620, United States
Houston Endocrinology Center

Houston, Texas, 77040, United States
Illawarra Diabetes Service Clinical Trials & Research Unit

Wollongong, New South Wales, 2500, Australia
Indiana Uni School of Med-Ped

Indianapolis, Indiana, 46202-5209, United States
InnoDiab Forschung GmbH

Essen, 45136, Germany
Institut für Diabetesforschung Osnabrück

Osnabrück, 49080, Germany
International Diabetes Center

Minneapolis, Minnesota, 55416, United States
Iowa Diabetes Research

West Des Moines, Iowa, 50266, United States
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.

Piotrkow Trybunalski, 97-300, Poland
John Muir Health

Concord, California, 94520, United States
Latin Clinical Trial Ctr

Tamarac, Florida, 33321, United States
Life Spring Research Foundation LLC

Miami, Florida, 33130, United States
Loma Linda University Faculty Medical Clinics

Loma Linda, California, 92354, United States
Los Angeles Institute for Metabolic Research

Los Angeles, California, 90015, United States
Lynn Institute - East OKC

Oklahoma City, Oklahoma, 73111, United States
Lynn Institute of Norman

Norman, Oklahoma, 73069, United States
MEDISPEKTRUM s.r.o.

Bratislava, 851 01, Slovakia
MVZ Diabeteszentrum Dr. Tews GmbH

Gelnhausen, 63571, Germany
Maciej Wiza Gaja Poradnie Lekarskie

Poznan, 61-251, Poland
Macquarie University - Clinical Trials Unit

Macquarie Park, New South Wales, 2109, Australia
Mayo Clinic

Rochester, Minnesota, 55905, United States
McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, 31-261, Poland
MedStar Health Research Institute

Olney, Maryland, 20832, United States
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

Münster, 48153, Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

Berlin, 13597, Germany
Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States
Metabolica Sp. z o.o.

Tarnów, Lesser Poland Voivodeship, 33-100, Poland
MidState Endocrine Associates

Nashville, Tennessee, 37203, United States
Mills Health Center

San Mateo, California, 94401, United States
Minimed S.R.L.

Bacau, 600238, Romania
N. Texas Diab & Endo - Prime

Flower Mound, Texas, 75028, United States
NYC Research, Inc.

New York, New York, 10016, United States
NYU Langone Orthopedic Center

New York, New York, 10017, United States
North Texas Endocrine Center

Dallas, Texas, 75231, United States
Northeast Clinical Research of San Antonio

San Antonio, Texas, 78233, United States
Northeast Research Institute

Fleming Island, Florida, 32003, United States
Northeast Research Institute

Jacksonville, Florida, 32204, United States
Northwestern University

Chicago, Illinois, 60611, United States
Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada
Optumcare Clinical Trials,LLC-Golden

Golden, Colorado, 80401, United States
PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, 02-507, Poland
Pacific Clinical Studies

Los Alamitos, California, 90720, United States
Palm Research Center Inc.

Las Vegas, Nevada, 89148, United States
Pasadena Clinical Trials

Pasadena, California, 91101, United States
Physicians East Endocrinology

Greenville, North Carolina, 27834, United States
Physicians Research Assoc. LLC

Lawrenceville, Georgia, 30046, United States
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach

Eisenach, 99817, Germany
Precision Endo - Revival

Denton, Texas, 76210, United States
Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, L8L 5G4, Canada
Prevea Health

Green Bay, Wisconsin, 54303, United States
Prisma Health Endo Spc Thy Ctr

Greenville, South Carolina, 29605, United States
Profound Research LLC

Clarkston, Michigan, 48346, United States
Profound Research LLC

Farmington Hills, Michigan, 48334, United States
Providence Medical Foundation

Fullerton, California, 92835, United States
QCR Network

Omaha, Nebraska, 68114, United States
RGV Endocrine Center

McAllen, Texas, 78503, United States
Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States
Research Institute Of Dallas

Dallas, Texas, 75231, United States
Reumed Sp. z o.o.

Lublin, 20-607, Poland
Rio Clinical Trials

Ogden, Utah, 84404, United States
Robley Rex VA Medical Center

Louisville, Kentucky, 40206, United States
Rocky Mt Clin Res, LLC

Idaho Falls, Idaho, 83404-7596, United States
S.C. Dianutrilife Medica S.R.L.

Ploieşti, 100561, Romania
S.C. Top Diabet Srl

Craiova, Dolj, 200515, Romania
SC Diamed Obesity SRL

Galati, 800291, Romania
SC Nutrilife SRL

Bucharest, 013764, Romania
SRA Trials-Broward

Pembroke Pines, Florida, 33024, United States
Saint Louis University

St Louis, Missouri, 63103, United States
Scripps Whittier Diabetes Inst

La Jolla, California, 92037, United States
Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, South Australia, 5046, Australia
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

Timișoara, 300723, Romania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta

Constanța, 900591, Romania
Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, 550245, Romania
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava

Suceava, 720224, Romania
St Vincent's Hospital Melbourne - Endocrinology & Diabetes Department

Fitzroy, Victoria, 3065, Australia
Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States
Suncoast Clinical Research, Inc.

Palm Harbor, Florida, 34684, United States
Tekton Research

McKinney, Texas, 75069, United States
Texas Diab Endo ATX N Mopac EXPR

Austin, Texas, 78731, United States
Texas Diabetes & Endocrinology

Austin, Texas, 78749, United States
Texas Diabetes & Endocrinology_Round Rock

Round Rock, Texas, 78681, United States
The Endocrine Center

Houston, Texas, 77079, United States
The Ohio State University Medical Center

Columbus, Ohio, 43203, United States
The Royal Melbourne Hospital - Diabetes & Endocrinology Department

Parkville, Victoria, 3050, Australia
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
Thyroid Endocrinology & Diabetes PA

Dallas, Texas, 75208, United States
Townsville University Hospital

Townsville, Queensland, 4814, Australia
UVM Endocrinology

South Burlington, Vermont, 05403, United States
Uniklinik TU Dresden - Med. Klinik III

Dresden, 01307, Germany
University Clin Investigators

Tustin, California, 92780, United States
University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411, United States
University Of Chicago

Chicago, Illinois, 60637-1447, United States
University at Buffalo

Williamsville, New York, 14221, United States
University of Calgary

Calgary, Alberta, T2T 5C7, Canada
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
Uniwersyteckie Centrum Kliniczne (UCK)

Gdansk, 80-214, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.

Poznan, 60-354, Poland
Valley Diab. & Endo Comp Ctr

Weslaco, Texas, 78596, United States
Vancouver General Hospital_Vancouver_0

Vancouver, British Columbia, V5Z 1M9, Canada
Vanderbilt Medical Center_Nashville

Nashville, Tennessee, 37212, United States
Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States
Washington University

St Louis, Missouri, 63110, United States
Wendisch - Dahl Hamburg - DZHW

Hamburg, 22607, Germany
West Orange Endocrinology

Ocoee, Florida, 34761, United States
WestenU Health

Pomona, California, 91766, United States
Western University Centre for Studies in Fam Med

London, Ontario, N6G 2M1, Canada
Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada
Zanamed Medical Clinic Sp. z o.o.

Lublin, 20-601, Poland
Zentrum für klinische Studien Alexander Segner

Saint Ingbert-Oberwürzbach, 66386, Germany
Zentrum für klinische Studien Allgäu Oberschwaben

Wangen, 88239, Germany
Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZ

Zabrze, 41-800, Poland

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