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

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.

Conditions

Diabetes Mellitus, Type 1
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Related Conditions:

Diabetes Mellitus, Type 1

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Diabetes Mellitus, Type 1
Intervention / Treatment

-

Contacts and Locations

Cullman

Cullman Clinical Trials, Cullman, Alabama, United States, 35055

Concord

John Muir Health, Concord, California, United States, 94520

Escondido

Headlands Research California, LLC, Escondido, California, United States, 92025

Fresno

Clinical Res of Central Ca, Fresno, California, United States, 93704

Fullerton

Providence Medical Foundation, Fullerton, California, United States, 92835

La Jolla

Scripps Whittier Diabetes Inst, La Jolla, California, United States, 92037

Loma Linda

Loma Linda University Faculty Medical Clinics, Loma Linda, California, United States, 92354

Los Alamitos

Pacific Clinical Studies, Los Alamitos, California, United States, 90720

Pasadena

Pasadena Clinical Trials, Pasadena, California, United States, 91101

Pomona

WestenU Health, Pomona, California, United States, 91766

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novo Nordisk A/S,

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

Study Record Dates

2026-12-28