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

NCT07305805 | Recruiting Phase 1

• 3 other identifiers: NN1644-8194U1111-1317-28152025-521593-33
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state

  Measured in milligrams per kilogram (mg/kg).

  Visit 2 and 3: Day 2 and 3

Secondary Outcomes (6)

• GIRmax,SS: Maximum glucose infusion rate at steady state

  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

  Visit 2 and 3: Day 2 and 3

• AUC,I1063,SS: Area under the serum NNC0363-1063 concentration time curve at steady state

  Visit 2 and 3: Day 2 and 3

• Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration at steady state

  Visit 2 and 3: Day 2 and 3

• tmax,I1063,SS: Time to maximum observed serum NNC0363-1063 concentration at steady state

  Visit 2 and 3: Day 2 and 3

Study Arms (4)

Sequence 1

EXPERIMENTAL

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

Drug: NNC0363-1063

Sequence 2

EXPERIMENTAL

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

Drug: NNC0363-1063

Sequence 3

EXPERIMENTAL

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

Drug: NNC0363-1063

Sequence 4

EXPERIMENTAL

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

Drug: NNC0363-1063

Interventions

NNC0363-1063 DRUG

NNC0363-1063 will be administered subcutaneously.

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): May 17, 2026
• Study Completion (Estimated): May 21, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)