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New insulin put to the test with a surprise carb

NCT ID NCT07305805

Knowledge-focused Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a new insulin (NNC0363-1063) interacts with a non-glucose carbohydrate (a type of sweetener) in 36 adults with type 1 diabetes. Participants received fixed doses of the insulin and different amounts of the carbohydrate in random order over 4 tests. The goal was to see if taking them together is safe and how they affect blood sugar control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

36 people

The number who actually took part.

Started

Dec 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1

Contacts and locations

Locations

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.