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

June 4, 2026 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
Drug: NNC0363-1063
NNC0363-1063 will be administered subcutaneously.
Experimental: Sequence 2
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
Drug: NNC0363-1063
NNC0363-1063 will be administered subcutaneously.
Experimental: Sequence 3
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
Drug: NNC0363-1063
NNC0363-1063 will be administered subcutaneously.
Experimental: Sequence 4
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
Drug: NNC0363-1063
NNC0363-1063 will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state
Time Frame: Visit 2 and 3: Day 2 and 3
Measured in milligrams per kilogram (mg/kg).
Visit 2 and 3: Day 2 and 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GIRmax,SS: Maximum glucose infusion rate at steady state
Time Frame: Visit 2 and 3: Day 2 and 3
Measured in milligrams per kilogram*minute (mg/[kg*min]).
Visit 2 and 3: Day 2 and 3
Time to maximum glucose infusion rate (tGIRmax),SS: Time to maximum glucose infusion rate at steady state
Time Frame: Visit 2 and 3: Day 2 and 3
Measured in hours.
Visit 2 and 3: Day 2 and 3
AUC,I1063,SS: Area under the serum NNC0363-1063 concentration time curve at steady state
Time Frame: Visit 2 and 3: Day 2 and 3
Measured in hours*picomoles per litre (h*pmol/L).
Visit 2 and 3: Day 2 and 3
Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration at steady state
Time Frame: Visit 2 and 3: Day 2 and 3
Measured in picomoles per litre (pmol/L).
Visit 2 and 3: Day 2 and 3
tmax,I1063,SS: Time to maximum observed serum NNC0363-1063 concentration at steady state
Time Frame: Visit 2 and 3: Day 2 and 3
Measured in hours.
Visit 2 and 3: Day 2 and 3
Number of adverse events
Time Frame: Visit 2 and 3: Day 2 and 3
Measured as number of events.
Visit 2 and 3: Day 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), 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 Major Dates

Study Start (Actual)

December 16, 2025

Primary Completion (Actual)

April 21, 2026

Study Completion (Actual)

May 8, 2026

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1644-8194
  • U1111-1317-2815 (Other Identifier: World Health Organization (WHO))
  • 2025-521593-33 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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