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

John Muir Health
Concord, California 94520

Clinical Res of Central Ca
Fresno, California 93704

Loma Linda University Faculty Medical Clinics
Loma Linda, California 92354

Pasadena Clinical Trials
Pasadena, California 91101

Mills Health Center
San Mateo, California 94401

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

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Northeast Research Institute
Fleming Island, Florida 32003

Center for Diab,Obes & Metab
Pembroke Pines, Florida 33024

SRA Trials-Broward
Pembroke Pines, Florida 33024

Hanson Clinical Research Center
Port Charlotte, Florida 33952

Latin Clinical Trial Ctr
Tamarac, Florida 33321

Centricity Research Columbus
Columbus, Georgia 31904

Iowa Diabetes Research
West Des Moines, Iowa 50266

MedStar Health Research Institute
Olney, Maryland 20832

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

Profound Research LLC
Farmington Hills, Michigan 48334

Mayo Clinic
Rochester, Minnesota 55905

Washington University
St Louis, Missouri 63110

QCR Network
Omaha, Nebraska 68114

Palm Research Center Inc.
Las Vegas, Nevada 89148

Albuquerque Clinical Trials Inc.
Albuquerque, New Mexico 87102

NYC Research, Inc.
New York, New York 10016

NYU Langone Orthopedic Center
New York, New York 10017

University at Buffalo
Williamsville, New York 14221

Accellacare of Raleigh
Raleigh, North Carolina 27609

Lynn Institute - East OKC
Oklahoma City, Oklahoma 73111

Vanderbilt Medical Center_Nashville
Nashville, Tennessee 37212

Texas Diab Endo ATX N Mopac EXPR
Austin, Texas 78731

Alliance Clinical Network
Dallas, Texas 75203

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

Amir Ali Hassan, MD, PA
Houston, Texas 77089

Tekton Research
McKinney, Texas 75069

Texas Diabetes & Endocrinology_Round Rock
Round Rock, Texas 78681

Rio Clinical Trials
Ogden, Utah 84404

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