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

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

  • Diabetes Mellitus, Type 1

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, Alabama 35055

John Muir Health
Concord, California 94520

Headlands Research California, LLC
Escondido, California 92025

Clinical Res of Central Ca
Fresno, California 93704

Providence Medical Foundation
Fullerton, California 92835

Scripps Whittier Diabetes Inst
La Jolla, California 92037

Loma Linda University Faculty Medical Clinics
Loma Linda, California 92354

Pacific Clinical Studies
Los Alamitos, California 90720

Pasadena Clinical Trials
Pasadena, California 91101

Alliance Clinical Network
San Diego, California 92120

Mills Health Center
San Mateo, California 94401

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

University Clin Investigators
Tustin, California 92780

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Optumcare Clinical Trials,LLC-Golden
Golden, Colorado 80401

Northeast Research Institute
Fleming Island, Florida 32003

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

West Orange Endocrinology
Ocoee, Florida 34761

Suncoast Clinical Research, Inc.
Palm Harbor, Florida 34684

SRA Trials-Broward
Pembroke Pines, Florida 33024

Hanson Clinical Research Center
Port Charlotte, Florida 33952

Latin Clinical Trial Ctr
Tamarac, Florida 33321

Bayside Clinical Research
Tampa, Florida 33607

Metabolic Research Institute Inc
West Palm Beach, Florida 33401

Atlanta Diabetes Associates
Atlanta, Georgia 30318

Centricity Research Columbus
Columbus, Georgia 31904

Physicians Research Assoc. LLC
Lawrenceville, Georgia 30046

Endocrine Research Solutions, Inc
Roswell, Georgia 30076

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

University Of Chicago
Chicago, Illinois 60637-1447

Endeavor Health
Skokie, Illinois 60077

Iowa Diabetes Research
Des Moines, Iowa 50265

Cotton O’Neil Diabetes & Endocrinology
Topeka, Kansas 66606

MedStar Health Research Institute
Hyattsville, Maryland 20782

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

Profound Research LLC
Clarkston, Michigan 48346

Elite Clinical Research Center
Flint, Michigan 48532

International Diabetes Center
Minneapolis, Minnesota 55416

Mayo Clinic
Rochester, Minnesota 55905

Washington University
St Louis, Missouri 63110

University of Nebraska Medical Center
Omaha, Nebraska 68105

QCR Network
Omaha, Nebraska 68114

Palm Research Center Inc.
Las Vegas, Nevada 89148

Albuquerque Clinical Trials Inc.
Albuquerque, New Mexico 87102

AMC Community Endocrinology
Albany, New York 12203

NYC Research, Inc.
New York, New York 10016

NYU Langone Health
New York, New York 10016

University at Buffalo
Williamsville, New York 14221

Physicians East Endocrinology
Greenville, North Carolina 27834

Lucas Research Inc.
Morehead City, North Carolina 28557

Centricity Res New Bern
New Bern, North Carolina 28562

Accellacare Wilmington
Wilmington, North Carolina 28401

Diab & Endo Assoc of Stark Co
Canton, Ohio 44718

The Ohio State University Medical Center
Columbus, Ohio 43203

Alliance for Multispecialty Research
Norman, Oklahoma 73069

Lynn Institute of Norman
Norman, Oklahoma 73069

Lynn Institute - East OKC
Oklahoma City, Oklahoma 73111

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107

Prisma Health Endo Spc Thy Ctr
Greenville, South Carolina 29605

Holston Medical Group_Bristol
Bristol, Tennessee 37620

University Diabetes & Endocrine Consultants
Chattanooga, Tennessee 37411

MidState Endocrine Associates
Nashville, Tennessee 37203

Amarillo Medical Specialists
Amarillo, Texas 79124

Texas Diab Endo ATX N Mopac EXPR
Austin, Texas 78731

Texas Diabetes & Endocrinology
Austin, Texas 78749

Alliance Clinical Network
Dallas, Texas 75203

Thyroid Endocrinology & Diabetes PA
Dallas, Texas 75208

Velocity Clinical Res-Dallas
Dallas, Texas 75230

Research Institute Of Dallas
Dallas, Texas 75231

Precision Endo - Revival
Denton, Texas 76210

Epic Medical Research
DeSoto, Texas 75115

Frontier Medical Ctr
El Paso, Texas 79935

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

Houston Endocrinology Center
Houston, Texas 77040.

The Endocrine Center
Houston, Texas 77079

Amir Ali Hassan, MD, PA
Houston, Texas 77089

RGV Endocrine Center
McAllen, Texas 78503

Tekton Research
McKinney, Texas 75069

Be Well Clinical Studies
Round Rock, Texas 78681

Texas Diabetes & Endocrinology_Round Rock
Round Rock, Texas 78681

Northeast Clinical Research of San Antonio
San Antonio, Texas 78233

Valley Diab. & Endo Comp Ctr
Weslaco, Texas 78596

Rio Clinical Trials
Ogden, Utah 84404

Rainier Clin Res Ctr Inc
Renton, Washington 98057

Prevea Health
Green Bay, Wisconsin 54303

Centro de Endo Altagracia
Bayamón, Puerto Rico 00959

Advanced Clinical Research LLC
Bayamón, Puerto Rico 00961

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

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