Actively Recruiting

Phase 1
Age: 18Years - 64Years
All Genders
NCT07305805

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

Led by Novo Nordisk A/S · Updated on 2026-01-02

36

Participants Needed

1

Research Sites

22 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participant of non-child bearing potential (surgically sterilized or postmenopausal)
  • Age 18 to 64 years at signing informed consent
  • Body mass index between 18.5 and 29.9 kg/m² at screening
  • Diagnosed with type 1 diabetes mellitus at least 1 year before screening
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for at least 90 days before screening
  • Glycated haemoglobin (HbA1c) less than or equal to 9.0% at screening
Not Eligible

You will not qualify if you...

  • Male of reproductive age not using adequate contraception or whose female partner is not using adequate contraception
  • Any condition except mild, stable type 1 diabetes related conditions that might jeopardize safety or study compliance according to investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany, 41460

Actively Recruiting

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Research Team

N

Novo Nordisk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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