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NCT07076199PHASE3Recruiting

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

Novo Nordisk A/S

Start Date

8/11/2025

Completion Date

3/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Insulin icodec

DRUG

Insulin glargine

DRUG

Insulin aspart

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Conditions

Diabetes Mellitus, Type 1

Locations

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

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

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

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

Saint Louis University

St Louis, Missouri 63103

United States

Washington University

St Louis, Missouri 63110

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

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

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

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

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 L8M 1K7

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 rech Clin de Laval

Laval, Quebec H7T 2P5

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

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

Gabinet Lekarski Malgorzata Saryusz-Wolska

Lodz, 90-132

Poland

Zanamed Medical Clinic Sp. z o.o.

Lublin, 20-601

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

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