New insulin NNC0363-1063 plus a non‑glucose carbohydrate for people with type 1 diabetes

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

This will test whether giving a new insulin called NNC0363-1063 together with different amounts of a non‑glucose carbohydrate is safe and how they interact in adults with type 1 diabetes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Neuss)
• Trial ID: NCT07305805 on ClinicalTrials.gov

What this trial studies

This is a phase 1, randomized interaction study in adults with type 1 diabetes that gives a fixed dose of NNC0363-1063 together with oral administrations of varying amounts of a non‑glucose carbohydrate. Each participant undergoes four interaction test sessions in random order to observe safety, tolerability, and pharmacodynamic responses. Participants must be on stable insulin therapy and are followed with clinical and laboratory monitoring over about 5 to 12 weeks. The trial is sponsored by Novo Nordisk and conducted at a single site in Neuss, Germany.

Who should consider this trial

Good fit: Adults aged 18–64 with type 1 diabetes for at least one year, treated with multiple daily injections or insulin pump for ≥90 days, BMI 18.5–29.9 kg/m2, HbA1c ≤9%, and not of childbearing potential are ideal candidates.

Not a fit: People under 18 or over 64, those of childbearing potential, with BMI or HbA1c outside the specified ranges, or who do not meet other exclusion criteria are unlikely to qualify or benefit from this phase 1 interaction testing.

Why it matters

Potential benefit: If successful, the results could clarify safe co‑administration conditions and inform dosing or dietary guidance for people using this new insulin.

How similar studies have performed: Early insulin–nutrient interaction studies have been done before, but this specific insulin (NNC0363-1063) together with the tested non‑glucose carbohydrate is a novel combination being examined in first‑in‑human/early clinical interactions.

Eligibility criteria

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.

Where this trial is running

Neuss

• Profil Institut für Stoffwechselforschung GmbH — Neuss, Germany (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Diabetes Mellitus, Type 1