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New Fast-Acting insulin pump treatment shows promise for type 2 diabetes

NCT ID NCT07068295

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new fast-acting insulin called NNC0471-0119 in 65 adults with type 2 diabetes who use an insulin pump. Researchers compared how quickly the new insulin enters the bloodstream and lowers blood sugar versus a standard insulin (insulin aspart). The goal is to see if the new insulin works faster and is safe for pump use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NNC0471-0119 (a fast-acting insulin) and insulin aspart (comparator)
What this could lead to
If successful, this could lead to a faster-acting insulin option for insulin pumps, potentially improving blood sugar control after meals for people with type 2 diabetes.
What could go wrong
This is an early phase 1 study with only 65 participants, so results may not apply to everyone. The new insulin may not work better or could have unexpected side effects.

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

65 people

The number who actually took part.

Started

Jul 2025

Finished

Mar 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 69 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 (sex at birth). * Age 18-69 years (both inclusive) at the time of signing the informed consent. * Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening. * Treated with any injectable insulin, except once-weekly insulin, ≥ 180 days before screening. * Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day \[(I) U/kg/day\] (both inclusive) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening: * Any metformin formulation * Dipeptidyl peptidase-4 inhibitor (DPP4i) * Sodium-glucose Cotransporter-2 inhibitor (SGLT2i) * Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening. * HbA1c lesser than or equal to (≤) 9.5% Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus type 2

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.