A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar

Last updated: April 3, 2026
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Treatment

Insulin icodec

Clinical Study ID

NCT07160816
NN1436-8404
U1111-1316-7988
  • Ages > 18
  • All Genders

Study Summary

The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 1 diabetes (T1D) will be treated with insulin icodec as prescribed to by their doctor, in accordance with usual clinical practice. This study will last for about 22 to 30 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-relatedactivities are any procedures related to recording of data according to theprotocol).

  • The decision to initiate treatment with commercially available insulin icodec hasbeen made by the participant/legally acceptable representative (LAR) and thetreating physician before and independently from the decision to include theparticipant in this study.

  • Male or female, age greater than or equal to (≥) 18 years at the time of signinginformed consent.

  • Diagnosed with T1D ≥ 1 year before signing informed consent.

  • Treated with multiple daily insulin injections (daily basal insulin analogue andbolus insulin analogue regimen) ≥ 6 months before signing informed consent.

  • Available HbA1c value less than or equal to (≤) 90 days prior to the 'Initiationvisit' (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

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having giveninformed consent in this study.

  • Treatment with any investigational drug within 30 days prior to enrolment into thestudy.

  • Mental incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.

Study Design

Total Participants: 245
Treatment Group(s): 1
Primary Treatment: Insulin icodec
Phase:
Study Start date:
August 28, 2025
Estimated Completion Date:
January 20, 2027

Connect with a study center

  • Hausärztliche und Diabetologische Praxis Pirna

    Pirna, LÄK Sachsen 01796
    Germany

    Active - Recruiting

  • Hausärztliche und Diabetologische Praxis Pirna

    Pirna 2853572, LÄK Sachsen 01796
    Germany

    Site Not Available

  • Zuckerpraxis Dr. Ewald Jammers

    Bramsche, 49565
    Germany

    Site Not Available

  • Zuckerpraxis Dr. Ewald Jammers

    Bramsche 2945474, 49565
    Germany

    Site Not Available

  • Studiengesellschaft Dres. Könemann/Steinmann GbR

    Bünde, 32257
    Germany

    Site Not Available

  • Studiengesellschaft Dres. Könemann/Steinmann GbR

    Bünde 2941694, 32257
    Germany

    Site Not Available

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

    Dortmund, 44137
    Germany

    Site Not Available

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

    Dortmund 2935517, 44137
    Germany

    Site Not Available

  • Diabeteszentrum Duisburg-Mitte

    Duisburg, 47051
    Germany

    Site Not Available

  • Diabeteszentrum Duisburg-Mitte

    Duisburg 2934691, 47051
    Germany

    Site Not Available

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

    Fulda, 36037
    Germany

    Site Not Available

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

    Fulda 2923822, 36037
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. Martin Grüneberg

    Herne, 64649
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. Martin Grüneberg

    Herne 2905891, 64649
    Germany

    Site Not Available

  • Mesut Durmaz, Hof

    Hof, 95030
    Germany

    Site Not Available

  • Mesut Durmaz, Hof

    Hof 2902768, 95030
    Germany

    Site Not Available

  • Dr. Carola Lüke

    Jerichow, 39319
    Germany

    Active - Recruiting

  • Dr. Carola Lüke

    Jerichow 2895008, 39319
    Germany

    Site Not Available

  • Diabetespraxis Kiel

    Kiel, 24114
    Germany

    Site Not Available

  • Diabetespraxis Kiel

    Kiel 2891122, 24114
    Germany

    Site Not Available

  • Praxis Am Oberen Tor - Dr. Simon-Wagner

    Lichtenfels, 96215
    Germany

    Site Not Available

  • Praxis Am Oberen Tor - Dr. Simon-Wagner

    Lichtenfels 2878074, 96215
    Germany

    Site Not Available

  • Diabetologie Dr. Eidenmüller

    Marburg, 35037
    Germany

    Site Not Available

  • Diabetologie Dr. Eidenmüller

    Marburg 2873759, 35037
    Germany

    Site Not Available

  • Dr. Bernhard Landers

    Mayen, 56727
    Germany

    Site Not Available

  • Dr. Bernhard Landers

    Mayen 2872649, 56727
    Germany

    Site Not Available

  • Diabeteszentrum Bogenhausen

    München, 81927
    Germany

    Completed

  • Diabeteszentrum Bogenhausen

    München 2867711, 81927
    Germany

    Site Not Available

  • Medicover Neu-Ulm MVZ

    Neu-Ulm, 89231
    Germany

    Completed

  • Medicover Neu-Ulm MVZ

    Neu-Ulm 2863941, 89231
    Germany

    Site Not Available

  • Diabetespraxis Oranienburg

    Oranienburg, 16515
    Germany

    Site Not Available

  • Diabetespraxis Oranienburg

    Oranienburg 2857129, 16515
    Germany

    Site Not Available

  • Diabetesschwerpunktpraxis Dr. Martina Lange

    Rheinbach, 53359
    Germany

    Site Not Available

  • Diabetesschwerpunktpraxis Dr. Martina Lange

    Rheinbach 2847666, 53359
    Germany

    Site Not Available

  • Med.Versorgungszentrum Riesa-Dr. Bieler

    Riesa, 01587
    Germany

    Site Not Available

  • Med.Versorgungszentrum Riesa-Dr. Bieler

    Riesa 2846939, 01587
    Germany

    Site Not Available

  • Dr. med. Carsten Schürfeld, GZ-Vauban

    Saarlouis, 66740
    Germany

    Completed

  • Dr. med. Carsten Schürfeld, GZ-Vauban

    Saarlouis 2842632, 66740
    Germany

    Site Not Available

  • Diabetespraxis Schorndorf Dr. Hensel

    Schorndorf, 73614
    Germany

    Site Not Available

  • Diabetespraxis Schorndorf Dr. Hensel

    Schorndorf 2836320, 73614
    Germany

    Site Not Available

  • Praxis Dr. Zimmermann

    Sonsbeck, 47665
    Germany

    Site Not Available

  • Praxis Dr. Zimmermann

    Sonsbeck 2831105, 47665
    Germany

    Site Not Available

  • Endokrinologikum Ulm

    Ulm, 89073
    Germany

    Site Not Available

  • Endokrinologikum Ulm

    Ulm 2820256, 89073
    Germany

    Site Not Available

  • Diabetespraxis Viersen

    Viersen, 41747
    Germany

    Site Not Available

  • Diabetespraxis Viersen

    Viersen 2817311, 41747
    Germany

    Site Not Available

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

    Milan, Lombardy 20121
    Italy

    Active - Recruiting

  • ASST FBF Sacco - Ospedale Luigi Sacco

    Milan, Lombardy 20157
    Italy

    Site Not Available

  • ASST Fatebenefratelli Sacco - Ospedale Macedonio Melloni

    Milan, Lombardy 20129
    Italy

    Active - Recruiting

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

    Milan, Lombardy 20132
    Italy

    Active - Recruiting

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

    Milan 3173435, Lombardy 3174618 20132
    Italy

    Site Not Available

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

    Turin, Piedmont 10122
    Italy

    Active - Recruiting

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

    Turin 3165524, Piedmont 3170831 10122
    Italy

    Site Not Available

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

    Livorno, Tuscany 57124
    Italy

    Site Not Available

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

    Lucca, Tuscany 55100
    Italy

    Site Not Available

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

    Livorno 3174659, Tuscany 3165361 57124
    Italy

    Site Not Available

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

    Lucca 3174530, Tuscany 3165361 55100
    Italy

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo 3182164, 24127
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, 88100
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro 2525059, 88100
    Italy

    Site Not Available

  • Azienda Ospedaliera Luigi Sacco

    Milan 6951411, 20157
    Italy

    Site Not Available

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

    Naples, 80138
    Italy

    Active - Recruiting

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

    Naples 3172394, 80138
    Italy

    Site Not Available

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

    Perugia, 06129
    Italy

    Site Not Available

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

    Perugia 3171180, 06129
    Italy

    Site Not Available

  • DIABETOLOGIA Ravenna AUSL della Romagna

    Ravenna, 48121
    Italy

    Site Not Available

  • DIABETOLOGIA Ravenna AUSL della Romagna

    Ravenna 3169561, 48121
    Italy

    Site Not Available

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

    Roma, 00161
    Italy

    Active - Recruiting

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

    Roma 8957247, 00161
    Italy

    Site Not Available

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

    Rome, 00168
    Italy

    Site Not Available

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

    Rome 3169070, 00168
    Italy

    Site Not Available

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