RECRUITING

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

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Conditions

Diabetes Mellitus, Type 1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-11
Study Completion:2026-12-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07076199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
  2. * Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
  3. * 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.
  4. * Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.
  1. * Known or suspected hypersensitivity to study intervention(s) or related products.
  2. * Previous participation in this study. Participation is defined as signed informed consent.
  3. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  4. * 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.
  5. * 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.
  6. * 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).
  7. * Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
  8. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Contacts and Locations

Study Contact

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

Principal Investigator

Clinical Transparency (dept. 2834)
STUDY_DIRECTOR
Novo Nordisk A/S

Study Locations (Sites)

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
Pacific Clinical Studies
Los Alamitos, California, 90720
United States
Pasadena Clinical Trials
Pasadena, California, 91101
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
Optumcare Colorado Springs
Golden, Colorado, 80401
United States
Northeast Research Institute
Fleming Island, Florida, 32003
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
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
Des Moines, Iowa, 50265
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
Hyattsville, Maryland, 20782
United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115-5804
United States
Profound Research LLC
Clarkston, Michigan, 48346
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
Washington University
St Louis, Missouri, 63110
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105
United States
QCR Network
Omaha, Nebraska, 68114
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 Health
New York, New York, 10016
United States
University at Buffalo
Williamsville, New York, 14221
United States
Physicians East Endocrinology
Greenville, North Carolina, 27834
United States
Lucas Research Inc.
Morehead City, North Carolina, 28557
United States
Centricity Res New Bern
New Bern, North Carolina, 28562
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
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, 37232
United States
Amarillo Medical Specialists
Amarillo, Texas, 79106
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
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
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
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

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

  • Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11
Study Completion Date2026-12-28

Study Record Updates

Study Start Date2025-08-11
Study Completion Date2026-12-28

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 1