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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Insulin icodec + insulin aspart 		Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
  • Drug: Insulin icodec
    Insulin icodec will be administered as subcutaneous injection
  • Drug: Insulin aspart
    Insulin aspart will be administered as a subcutaneous injection.
Active Comparator
Insulin glargine+ insulin aspart 		Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
  • Drug: Insulin glargine
    Insulin glargine will be administered as subcutaneous injection.
  • Drug: Insulin aspart
    Insulin aspart will be administered as a subcutaneous injection.

Recruiting Locations

Cullman Clinical Trials
Cullman 4057835, Alabama 4829764 35055

John Muir Health
Concord 5339111, California 5332921 94520

Headlands Research California, LLC
Escondido 5346827, California 5332921 92025

Clinical Res of Central Ca
Fresno 5350937, California 5332921 93704

Providence Medical Foundation
Fullerton 5351247, California 5332921 92835

Scripps Whittier Diabetes Inst
La Jolla 5363943, California 5332921 92037

Loma Linda University Faculty Medical Clinics
Loma Linda 5367696, California 5332921 92354

Pacific Clinical Studies
Los Alamitos 5368304, California 5332921 90720

Pasadena Clinical Trials
Pasadena 5381396, California 5332921 91101

Alliance Clinical Network
San Diego 5391811, California 5332921 92120

Mills Health Center
San Mateo 5392423, California 5332921 94401

Center for Endocrine DM and Metabolic Disorders
Santa Clarita 5393049, California 5332921 91321

University Clin Investigators
Tustin 5404119, California 5332921 92780

Diablo Clinical Research, Inc.
Walnut Creek 5406990, California 5332921 94598

Optumcare Clinical Trials,LLC-Golden
Golden 5423294, Colorado 5417618 80401

Northeast Research Institute
Fleming Island 4155594, Florida 4155751 32003

Suncoast Clinical Research, Inc.
New Port Richey 4165869, Florida 4155751 34652

West Orange Endocrinology
Ocoee 4166776, Florida 4155751 34761

Suncoast Clinical Research, Inc.
Palm Harbor 4167545, Florida 4155751 34684

SRA Trials-Broward
Pembroke Pines 4168139, Florida 4155751 33024

Hanson Clinical Research Center
Port Charlotte 4169130, Florida 4155751 33952

Latin Clinical Trial Ctr
Tamarac 4174738, Florida 4155751 33321

Bayside Clinical Research
Tampa 4174757, Florida 4155751 33607

Metabolic Research Institute Inc
West Palm Beach 4177887, Florida 4155751 33401

Atlanta Diabetes Associates
Atlanta 4180439, Georgia 4197000 30318

Centricity Research Columbus
Columbus 4188985, Georgia 4197000 31904

Physicians Research Assoc. LLC
Lawrenceville 4205196, Georgia 4197000 30046

Endocrine Research Solutions, Inc
Roswell 4219934, Georgia 4197000 30076

Rocky Mt Clin Res, LLC
Idaho Falls 5596475, Idaho 5596512 83404-7596

University Of Chicago
Chicago 4887398, Illinois 4896861 60637-1447

Endeavor Health
Skokie 4911600, Illinois 4896861 60077

Iowa Diabetes Research
Des Moines 4853828, Iowa 4862182 50265

Cotton O’Neil Diabetes & Endocrinology
Topeka 4280539, Kansas 4273857 66606

MedStar Health Research Institute
Hyattsville 4358821, Maryland 4361885 20782

Brigham & Women's Hospital
Boston 4930956, Massachusetts 6254926 02115-5804

Profound Research LLC
Clarkston 4988997, Michigan 5001836 48346

Elite Clinical Research Center
Flint 4992982, Michigan 5001836 48532

International Diabetes Center
Minneapolis 5037649, Minnesota 5037779 55416

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

Washington University
St Louis 4407066, Missouri 4398678 63110

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68105

QCR Network
Omaha 5074472, Nebraska 5073708 68114

Palm Research Center Inc.
Las Vegas 5506956, Nevada 5509151 89148

Albuquerque Clinical Trials Inc.
Albuquerque 5454711, New Mexico 5481136 87102

AMC Community Endocrinology
Albany 5106834, New York 5128638 12203

NYC Research, Inc.
New York 5128581, New York 5128638 10016

NYU Langone Health
New York 5128581, New York 5128638 10016

University at Buffalo
Williamsville 5144588, New York 5128638 14221

Physicians East Endocrinology
Greenville 4469160, North Carolina 4482348 27834

Lucas Research Inc.
Morehead City 4480153, North Carolina 4482348 28557

Centricity Res New Bern
New Bern 4481682, North Carolina 4482348 28562

Accellacare Wilmington
Wilmington 4499379, North Carolina 4482348 28401

Diab & Endo Assoc of Stark Co
Canton 5149222, Ohio 5165418 44718

The Ohio State University Medical Center
Columbus 4509177, Ohio 5165418 43203

Alliance for Multispecialty Research
Norman 4543762, Oklahoma 4544379 73069

Lynn Institute of Norman
Norman 4543762, Oklahoma 4544379 73069

Lynn Institute - East OKC
Oklahoma City 4544349, Oklahoma 4544379 73111

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107

Prisma Health Endo Spc Thy Ctr
Greenville 4580543, South Carolina 4597040 29605

Holston Medical Group_Bristol
Bristol 4608657, Tennessee 4662168 37620

University Diabetes & Endocrine Consultants
Chattanooga 4612862, Tennessee 4662168 37411

MidState Endocrine Associates
Nashville 4644585, Tennessee 4662168 37203

Amarillo Medical Specialists
Amarillo 5516233, Texas 4736286 79124

Texas Diab Endo ATX N Mopac EXPR
Austin 4671654, Texas 4736286 78731

Texas Diabetes & Endocrinology
Austin 4671654, Texas 4736286 78749

Alliance Clinical Network
Dallas 4684888, Texas 4736286 75203

Thyroid Endocrinology & Diabetes PA
Dallas 4684888, Texas 4736286 75208

Velocity Clinical Res-Dallas
Dallas 4684888, Texas 4736286 75230

Research Institute Of Dallas
Dallas 4684888, Texas 4736286 75231

Precision Endo - Revival
Denton 4685907, Texas 4736286 76210

Epic Medical Research
DeSoto 4685524, Texas 4736286 75115

Frontier Medical Ctr
El Paso 5520993, Texas 4736286 79935

Diabetes and Thyroid Center of Fort Worth
Fort Worth 4691930, Texas 4736286 76132

Houston Endocrinology Center
Houston 4699066, Texas 4736286 77040.

The Endocrine Center
Houston 4699066, Texas 4736286 77079

Amir Ali Hassan, MD, PA
Houston 4699066, Texas 4736286 77089

RGV Endocrine Center
McAllen 4709796, Texas 4736286 78503

Tekton Research
McKinney 4710178, Texas 4736286 75069

Be Well Clinical Studies
Round Rock 4724129, Texas 4736286 78681

Texas Diabetes & Endocrinology_Round Rock
Round Rock 4724129, Texas 4736286 78681

Northeast Clinical Research of San Antonio
San Antonio 4726206, Texas 4736286 78233

Valley Diab. & Endo Comp Ctr
Weslaco 4740629, Texas 4736286 78596

Rio Clinical Trials
Ogden 5779206, Utah 5549030 84404

Rainier Clin Res Ctr Inc
Renton 5808189, Washington 5815135 98057

Prevea Health
Green Bay 5254962, Wisconsin 5279468 54303

Centro de Endo Altagracia
Bayamón 4562831, Puerto Rico 00959

Advanced Clinical Research LLC
Bayamón 4562831, Puerto Rico 00961

More Details

NCT ID
NCT07076199
Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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