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New Once-Weekly insulin shows promise for diabetes control in italian study

NCT ID NCT07632404

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This study looks at how well a new insulin called icodec controls blood sugar in adults with type 2 diabetes who are switching from their current daily insulin. About 214 participants in Italy will use icodec as prescribed by their doctor for 22 to 30 weeks. Researchers will measure changes in blood sugar levels and how satisfied patients are with their treatment.

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.

Participants

About 214 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Who is studied

The study population comprises participants who are diagnosed with type 2 diabetes and agree to be treated with insulin icodec after consultation with their physician independently from the decision to participate in this study.

Ages

18 years and older

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: * Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * The decision to initiate treatment with commercially available insulin icodec has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study. * Male or female, age above or equal to 18 years at the time of signing informed consent. * Diagnosed with T2D greater than or equal to (≥) 1 year before signing informed consent. * Treated with once- or twice-daily basal insulin injections ≥ 6 months before signing informed consent. Any other antidiabetic medications are allowed, except for bolus insulin during the 90 days prior to switching to icodec for a period of 14 days or more. * Available HbA1c within 90 days prior to the 'Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Initiation visit' (V1) if in line with local clinical practice. * Treatment-naïve to once-weekly insulin prior to the 'Initiation Visit' (V1). Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study. * Treatment with any investigational drug within 30 days prior to enrolment into the study. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ARNAS Garibaldi Catania

    Catania, Sicily, 95123, Italy

  • ASL Avellino

    Montoro, 83026, Italy

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata

    Rome, Lazio, 00133, Italy

  • Azienda Ospedaliera Santa Croce E Carle

    Cuneo, Piedmont, 12100, Italy

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128, Italy

  • Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Medicina interna

    Rome, Lazio, 00189, Italy

  • Azienda Sanitaria Locale Di Pescara

    Pescara, Abruzzo, 65124, Italy

  • Azienda Sanitaria Locale Napoli 2 Nord

    Marano Di Napoli (NA), Campania, 80016, Italy

  • Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo

    Milan, Lombardy, 20142, Italy

  • Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia

    Milan, Lombardy, 20159, Italy

  • IRCCS Multimedica Sesto San Giovanni

    San Giovanni in Fiore (CS), Calabria, 87027, Italy

  • Ospedale Generale provinciale

    Province of Macerata, 62100, Italy

  • Ospedale centrale L. Bohler Bolzano

    Bolzano, Trentino-Alto Adige, 39100, Italy

  • Ospedale di Città di Castello

    Città di Castello, 06012, Italy

  • Policlinico Casilino

    Rome, Lazio, 00169, Italy

More trials for these conditions

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