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Completed

NCT Number: NCT07305805

A Research Study of a New Medicine 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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0363-1063

Drug

NNC0363-1063 will be administered subcutaneously.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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]).

  2. 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.

  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).

  4. 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).

  5. 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.

  6. Number of adverse events

    Time frame: Visit 2 and 3: Day 2 and 3

    Measured as number of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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