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

NCT ID: NCT07305805

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-05-21

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.

Group Type EXPERIMENTAL

NNC0363-1063

Intervention Type DRUG

NNC0363-1063 will be administered subcutaneously.

Sequence 2

Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.

Group Type EXPERIMENTAL

NNC0363-1063

Intervention Type DRUG

NNC0363-1063 will be administered subcutaneously.

Sequence 3

Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.

Group Type EXPERIMENTAL

NNC0363-1063

Intervention Type DRUG

NNC0363-1063 will be administered subcutaneously.

Sequence 4

Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.

Group Type EXPERIMENTAL

NNC0363-1063

Intervention Type DRUG

NNC0363-1063 will be administered subcutaneously.

Interventions

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NNC0363-1063

NNC0363-1063 will be administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Central Contacts

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Novo Nordisk

Role: CONTACT

Phone: (+1) 866-867-7178

Email: [email protected]

Other Identifiers

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U1111-1317-2815

Identifier Type: OTHER

Identifier Source: secondary_id

2025-521593-33

Identifier Type: OTHER

Identifier Source: secondary_id

NN1644-8194

Identifier Type: -

Identifier Source: org_study_id