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A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes

A Multiple Dose Study Investigating Pharmacodynamics and Pharmacokinetics of Subcutaneous NNC0363-1063 in Participants With Type 1 Diabetes

NCT07305805•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. All participants will get a fixed dose of NNC0363-1063 and an oral administration of different amounts of the non-glucose carbohydrate in a random order during 4 interaction tests. The participants will be in this clinical study for about 5 to 12 weeks.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female participant (sex at birth) of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e., documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 month without an alternative medical cause) prior to the day of screening.
•Age 18-64 years (both inclusive) at the time of signing informed consent.
•Body mass index between 18.5-29.9 Kilogram Per Square Meter (kg/m\^2) (both inclusive) at the day of screening.
•Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year prior to the day of screening.
•Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion ≥ 90 days prior to the day of screening.
•Glycated haemoglobin (HbA1c) less than or equal to (≤ ) 9.0 percentage (%) at the day of screening.

Exclusion Criteria

•Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
•Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Locations (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Key Dates

Start Date

December 15, 2025

Primary Completion Date

May 17, 2026

Completion Date

May 21, 2026

Last Updated

January 2, 2026

Enrollment

ESTIMATED participants

Conditions

Diabetes Mellitus, Type 1

Interventions

NNC0363-1063

DRUG

Contacts

Novo Nordisk

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes

Inclusion Criteria

Exclusion Criteria

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