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
Status: Recruiting
Location: See all (182) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Cullman Clinical Trials
RECRUITING
Cullman
California
John Muir Health
RECRUITING
Concord
Headlands Research California, LLC
RECRUITING
Escondido
Clinical Res of Central Ca
RECRUITING
Fresno
Providence Medical Foundation
NOT_YET_RECRUITING
Fullerton
Scripps Whittier Diabetes Inst
RECRUITING
La Jolla
Loma Linda University Faculty Medical Clinics
RECRUITING
Loma Linda
Loma Linda University Faculty Medical Clinics
NOT_YET_RECRUITING
Loma Linda
Pacific Clinical Studies
RECRUITING
Los Alamitos
Pasadena Clinical Trials
RECRUITING
Pasadena
WestenU Health
COMPLETED
Pomona
WestenU Health
WITHDRAWN
Pomona
Alliance Clinical Network
RECRUITING
San Diego
Mills Health Center
RECRUITING
San Mateo
Center for Endocrine DM and Metabolic Disorders
RECRUITING
Santa Clarita
University Clin Investigators
RECRUITING
Tustin
Diablo Clinical Research, Inc.
RECRUITING
Walnut Creek
Colorado
Optumcare Clinical Trials,LLC-Golden
RECRUITING
Golden
Florida
Northeast Research Institute
RECRUITING
Fleming Island
Suncoast Clinical Research, Inc.
RECRUITING
New Port Richey
West Orange Endocrinology
RECRUITING
Ocoee
Suncoast Clinical Research, Inc.
RECRUITING
Palm Harbor
SRA Trials-Broward
RECRUITING
Pembroke Pines
Hanson Clinical Research Center
RECRUITING
Port Charlotte
Latin Clinical Trial Ctr
RECRUITING
Tamarac
Bayside Clinical Research
RECRUITING
Tampa
Metabolic Research Institute Inc
RECRUITING
West Palm Beach
Georgia
Atlanta Diabetes Associates
RECRUITING
Atlanta
Centricity Research Columbus
RECRUITING
Columbus
Physicians Research Assoc. LLC
RECRUITING
Lawrenceville
Endocrine Research Solutions, Inc
RECRUITING
Roswell
Iowa
Iowa Diabetes Research
RECRUITING
Des Moines
Idaho
Rocky Mt Clin Res, LLC
RECRUITING
Idaho Falls
Illinois
Northwestern University
COMPLETED
Chicago
University Of Chicago
RECRUITING
Chicago
Endeavor Health
RECRUITING
Skokie
Indiana
Indiana Uni School of Med-Ped
COMPLETED
Indianapolis
Kansas
Cotton O’Neil Diabetes & Endocrinology
RECRUITING
Topeka
Kentucky
Robley Rex VA Medical Center
NOT_YET_RECRUITING
Louisville
Massachusetts
Brigham & Women's Hospital
RECRUITING
Boston
Maryland
MedStar Health Research Institute
RECRUITING
Hyattsville
Michigan
Profound Research LLC
RECRUITING
Clarkston
Elite Clinical Research Center
RECRUITING
Flint
Minnesota
International Diabetes Center
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
Missouri
Saint Louis University
NOT_YET_RECRUITING
St Louis
Washington University
NOT_YET_RECRUITING
St Louis
North Carolina
Physicians East Endocrinology
RECRUITING
Greenville
Lucas Research Inc.
RECRUITING
Morehead City
Centricity Res New Bern
RECRUITING
New Bern
Accellacare Wilmington
RECRUITING
Wilmington
Nebraska
QCR Network
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Mexico
Albuquerque Clinical Trials Inc.
RECRUITING
Albuquerque
Nevada
Palm Research Center Inc.
RECRUITING
Las Vegas
New York
AMC Community Endocrinology
RECRUITING
Albany
NYC Research, Inc.
RECRUITING
New York
NYU Langone Health
NOT_YET_RECRUITING
New York
University at Buffalo
RECRUITING
Williamsville
Ohio
Diab & Endo Assoc of Stark Co
RECRUITING
Canton
Cleveland Clinic_Cleveland
NOT_YET_RECRUITING
Cleveland
The Ohio State University Medical Center
RECRUITING
Columbus
Oklahoma
Alliance for Multispecialty Research
RECRUITING
Norman
Lynn Institute of Norman
RECRUITING
Norman
Lynn Institute - East OKC
RECRUITING
Oklahoma City
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
South Carolina
Prisma Health Endo Spc Thy Ctr
RECRUITING
Greenville
Tennessee
Holston Medical Group_Bristol
RECRUITING
Bristol
University Diabetes & Endocrine Consultants
RECRUITING
Chattanooga
MidState Endocrine Associates
RECRUITING
Nashville
Vanderbilt Medical Center_Nashville
NOT_YET_RECRUITING
Nashville
Texas
Amarillo Medical Specialists
RECRUITING
Amarillo
Texas Diab Endo ATX N Mopac EXPR
RECRUITING
Austin
Texas Diabetes & Endocrinology
RECRUITING
Austin
Alliance Clinical Network
RECRUITING
Dallas
North Texas Endocrine Center
COMPLETED
Dallas
Research Institute Of Dallas
RECRUITING
Dallas
Thyroid Endocrinology & Diabetes PA
RECRUITING
Dallas
Velocity Clinical Res-Dallas
RECRUITING
Dallas
Precision Endo - Revival
RECRUITING
Denton
Epic Medical Research
RECRUITING
Desoto
Frontier Medical Ctr
RECRUITING
El Paso
N. Texas Diab & Endo - Prime
WITHDRAWN
Flower Mound
N. Texas Diab & Endo - Prime
COMPLETED
Flower Mound
Diabetes and Thyroid Center of Fort Worth
RECRUITING
Fort Worth
Amir Ali Hassan, MD, PA
RECRUITING
Houston
Houston Endocrinology Center
RECRUITING
Houston
The Endocrine Center
RECRUITING
Houston
RGV Endocrine Center
RECRUITING
Mcallen
Tekton Research
RECRUITING
Mckinney
Be Well Clinical Studies
RECRUITING
Round Rock
Texas Diabetes & Endocrinology_Round Rock
RECRUITING
Round Rock
Northeast Clinical Research of San Antonio
RECRUITING
San Antonio
Valley Diab. & Endo Comp Ctr
RECRUITING
Weslaco
Utah
Rio Clinical Trials
RECRUITING
Ogden
Vermont
UVM Endocrinology
COMPLETED
South Burlington
Washington
Rainier Clin Res Ctr Inc
RECRUITING
Renton
Wisconsin
Prevea Health
RECRUITING
Green Bay
Other Locations
Australia
St Vincent's Hospital - Melbourne
RECRUITING
Fitzroy
Austin Health, Metabolic Disorders Centre
RECRUITING
Heidelberg Heights
Macquarie University
RECRUITING
Macquarie Park
Southern Adelaide Diabetes & Endocrine Services
RECRUITING
Oaklands Park
The Royal Melbourne Hospital
RECRUITING
Parkville
Townsville University Hospital
RECRUITING
Townsville
Illawarra Diabetes Service Clinical Trials & Research Unit
RECRUITING
Wollongong
Canada
Centricity Research Brampton
RECRUITING
Brampton
Centricity Research Calgary
RECRUITING
Calgary
University of Calgary
COMPLETED
Calgary
Centricity Research Etobicoke
RECRUITING
Etobicoke
Nova Scotia Health Authority
RECRUITING
Halifax
Premier Clinical Trial Research Network (PCTRN)
RECRUITING
Hamilton
Ctr de rech Clin de Laval
COMPLETED
Laval
Ctr de rech Clin de Laval
WITHDRAWN
Laval
Western University Centre for Studies in Fam Med
RECRUITING
London
Centricity Research Mirabel
RECRUITING
Mirabel
Clinique Endocrinologie OASIS.
RECRUITING
Montreal
McGill University Health Centre
NOT_YET_RECRUITING
Montreal
Clin des Mal Lipid de Quebec
RECRUITING
Québec
Centre de Médecine Métabolique de Lanaudière
NOT_YET_RECRUITING
Terrebonne
Centre de Médecine Métabolique de Lanaudière
RECRUITING
Terrebonne
Centricity Research LMC
COMPLETED
Toronto
Centricity Research Toronto LMC Multispec
RECRUITING
Toronto
Vancouver General Hospital_Vancouver_0
NOT_YET_RECRUITING
Vancouver
Winnipeg Clinic
RECRUITING
Winnipeg
Germany
Diabetespraxis Mergentheim
RECRUITING
Bad Mergentheim
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
RECRUITING
Bad Oeynhausen
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
RECRUITING
Berlin
DSP Bochum, Diabetes- und Stoffwechselpraxis
RECRUITING
Bochum
Uniklinik TU Dresden - Med. Klinik III
RECRUITING
Dresden
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
NOT_YET_RECRUITING
Eisenach
InnoDiab Forschung GmbH
RECRUITING
Essen
MVZ Diabeteszentrum Dr. Tews GmbH
COMPLETED
Gelnhausen
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
RECRUITING
Hamburg
Diabetes-Zentrum-Wilhelmsburg GbR
RECRUITING
Hamburg
Wendisch/Dahl Hamburg (DZHW)
RECRUITING
Hamburg
Die Praxis am Ludwigsplatz
RECRUITING
Ludwigshafen
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
RECRUITING
Münster
Institut für Diabetesforschung Osnabrück
RECRUITING
Osnabrück
Zentrum für klinische Studien Alexander Segner
RECRUITING
Saint Ingbert-oberwürzbach
Zentrum für klinische Studien Allgäu Oberschwaben
RECRUITING
Wangen
Poland
Centrum Medyczne Intercor Sp. z o.o.
NOT_YET_RECRUITING
Bydgoszcz
Uniwersyteckie Centrum Kliniczne (UCK)
NOT_YET_RECRUITING
Gdansk
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
RECRUITING
Krakow
Beata Miklaszewicz & Dariusz Dabrowski CARDIAMED s.j.
RECRUITING
Legnica
Gabinet Lekarski Malgorzata Saryusz-Wolska
NOT_YET_RECRUITING
Lodz
Gabinet Lekarski Malgorzata Saryusz-Wolska
RECRUITING
Lodz
Reumed Sp. z o.o.
RECRUITING
Lublin
Zanamed Medical Clinic Sp. z o.o.
RECRUITING
Lublin
Zanamed Medical Clinic Sp. z o.o.
NOT_YET_RECRUITING
Lublin
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spolka cywilna
NOT_YET_RECRUITING
Opole
Formed 2 Sp. z o.o.
RECRUITING
Oświęcim
Formed 2 Sp. z o.o.
NOT_YET_RECRUITING
Oświęcim
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
RECRUITING
Piotrkow Trybunalski
Gaja Poradnie Lekarskie
COMPLETED
Poznan
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.
RECRUITING
Poznan
Metabolica Sp. z o.o.
RECRUITING
Tarnów
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
RECRUITING
Warsaw
Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZ
NOT_YET_RECRUITING
Zabrze
Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZ
RECRUITING
Zabrze
Etg Zamosc Sp. z o.o.
RECRUITING
Zamość
Puerto Rico
Advanced Clinical Research LLC
RECRUITING
Bayamón
Centro de Endo Altagracia
RECRUITING
Bayamón
Romania
CMI Dr. Pletea Noemi SRL
RECRUITING
Bacau
Minimed S.R.L.
RECRUITING
Bacau
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
RECRUITING
Brasov
Diabs&Nutricare Srl
NOT_YET_RECRUITING
Bucharest
SC Nutrilife SRL
RECRUITING
Bucharest
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
RECRUITING
Constanța
S.C. Top Diabet Srl
RECRUITING
Craiova
SC Diamed Obesity SRL
RECRUITING
Galati
Diabmed Dr Popescu Alexandrina SRL
RECRUITING
Ploieşti
S.C. Dianutrilife Medica S.R.L.
RECRUITING
Ploieşti
Clinica Korall S.R.L. Satu Mare
RECRUITING
Satu Mare
Spitalul Clinic Judetean de Urgenta Sibiu
RECRUITING
Sibiu
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
RECRUITING
Suceava
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
RECRUITING
Timișoara
Slovakia
DIABEDA s.r.o.
RECRUITING
Bratislava
MEDISPEKTRUM s.r.o.
RECRUITING
Bratislava
Diab - Int, s.r.o.
RECRUITING
Bytča
DIADAN, s.r.o. Kosice
RECRUITING
Košice
DIOLI s.r.o.
RECRUITING
Košice
HUMAN-CARE, s.r.o.
RECRUITING
Košice
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-08-11
Estimated Completion Date: 2026-12-28
Participants
Target number of participants: 877
Treatments
Experimental: Insulin icodec + insulin aspart
Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
Active_comparator: Insulin glargine+ insulin aspart
Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S