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New insulin icodec study aims to improve diabetes control

NCT ID NCT07160816

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Updated 6 times

Summary

This study observes how well insulin icodec controls blood sugar in 245 people with type 1 diabetes who have never used it before. Participants take the insulin as prescribed by their doctor, and researchers track changes in HbA1c and treatment satisfaction over about 22 to 30 weeks. The goal is to see if this insulin helps manage diabetes effectively in real-world settings.

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 245 people

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

Started

Aug 2025

Expected to finish

Jan 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 1 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 procedures 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 greater than or equal to (≥) 18 years at the time of signing informed consent. * Diagnosed with T1D ≥ 1 year before signing informed consent. * Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before signing informed consent. * Available HbA1c value less than or equal to (≤) 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 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

  • A.O.U. Università Studi della Campania "Luigi Vanvitelli"

    Naples, 80138, Italy

  • ASST FBF Sacco - Ospedale Fatebenefratelli e Oftalmico - Oculistica - Istituto Oftalmico

    Milan, Lombardy, 20121, Italy

  • ASST FBF Sacco - Ospedale Luigi Sacco

    Milan, Lombardy, 20157, Italy

  • ASST Fatebenefratelli Sacco - Ospedale Macedonio Melloni

    Milan, Lombardy, 20129, Italy

  • AUSL Toscana Nord Ovest - Cittadella della Salute Campo di Marte - Diabetologia Lucca e Valle del Serchio

    Lucca, Tuscany, 55100, Italy

  • AUSL Toscana Nord Ovest - Ospedali Riuniti di Livorno - Diabetologia e Malattie del Metabolismo

    Livorno, Tuscany, 57124, Italy

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia

    Perugia, 06129, Italy

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, 88100, Italy

  • Azienda Sanitaria Locale Città di Torino - Ambulatorio Endocrinologia e Malattie Metaboliche

    Turin, Piedmont, 10122, Italy

  • DIABETOLOGIA Ravenna AUSL della Romagna

    Ravenna, 48121, Italy

  • Diabetespraxis Kiel

    Kiel, 24114, Germany

  • Diabetespraxis Oranienburg

    Oranienburg, 16515, Germany

  • Diabetespraxis Schorndorf Dr. Hensel

    Schorndorf, 73614, Germany

  • Diabetespraxis Viersen

    Viersen, 41747, Germany

  • Diabetesschwerpunktpraxis Dr. Martina Lange

    Rheinbach, 53359, Germany

  • Diabeteszentrum Bogenhausen

    München, 81927, Germany

  • Diabeteszentrum Duisburg-Mitte

    Duisburg, 47051, Germany

  • Diabeteszentrum-Do Dres. K U. Ch. Busch GbR

    Dortmund, 44137, Germany

  • Diabetologie Dr. Eidenmüller

    Marburg, 35037, Germany

  • Dr. Bernhard Landers

    Mayen, 56727, Germany

  • Dr. Carola Lüke

    Jerichow, 39319, Germany

  • Dr. med. Carsten Schürfeld, GZ-Vauban

    Saarlouis, 66740, Germany

  • Endokrinologikum Ulm

    Ulm, 89073, Germany

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche

    Rome, 00168, Italy

  • Gemeinschaftspraxis Dr. Martin Grüneberg

    Herne, 64649, Germany

  • Hausärztliche und Diabetologische Praxis Pirna

    Pirna, LÄK Sachsen, 01796, Germany

  • MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien

    Fulda, 36037, Germany

  • Med.Versorgungszentrum Riesa-Dr. Bieler

    Riesa, 01587, Germany

  • Medicover Neu-Ulm MVZ

    Neu-Ulm, 89231, Germany

  • Mesut Durmaz, Hof

    Hof, 95030, Germany

  • Ospedale San Raffaele S.r.l. - Unità Clinica Endocrinologia

    Milan, Lombardy, 20132, Italy

  • Praxis Am Oberen Tor - Dr. Simon-Wagner

    Lichtenfels, 96215, Germany

  • Praxis Dr. Zimmermann

    Sonsbeck, 47665, Germany

  • Studiengesellschaft Dres. Könemann/Steinmann GbR

    Bünde, 32257, Germany

  • Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale

    Roma, 00161, Italy

  • Zuckerpraxis Dr. Ewald Jammers

    Bramsche, 49565, Germany

More trials for these conditions

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