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

NCT ID: NCT07160816

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-28

Study Completion Date

2027-01-20

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Insulin icodec

Participants with T1D will be treated with commercially available insulin icodec according to routine clinical practice at the discretion of the treating physician.

Insulin icodec

Intervention Type DRUG

Participants with T1D will be treated with commercially available insulin icodec.

Interventions

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Insulin icodec

Participants with T1D will be treated with commercially available insulin icodec.

Intervention Type DRUG

Other Intervention Names

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Awiqli

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Hausärztliche und Diabetologische Praxis Pirna

Pirna, LÄK Sachsen, Germany

Site Status RECRUITING

Zuckerpraxis Dr. Ewald Jammers

Bramsche, , Germany

Site Status RECRUITING

Studiengesellschaft Dres. Könemann/Steinmann GbR

Bünde, , Germany

Site Status RECRUITING

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

Dortmund, , Germany

Site Status RECRUITING

Diabeteszentrum Duisburg-Mitte

Duisburg, , Germany

Site Status ENROLLING_BY_INVITATION

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

Fulda, , Germany

Site Status ENROLLING_BY_INVITATION

Gemeinschaftspraxis Dr. Martin Grüneberg

Herne, , Germany

Site Status RECRUITING

Mesut Durmaz, Hof

Hof, , Germany

Site Status RECRUITING

Dr. Carola Lüke

Jerichow, , Germany

Site Status ENROLLING_BY_INVITATION

Diabetespraxis Kiel

Kiel, , Germany

Site Status RECRUITING

Praxis Am Oberen Tor - Dr. Simon-Wagner

Lichtenfels, , Germany

Site Status RECRUITING

Diabetologie Dr. Eidenmüller

Marburg, , Germany

Site Status ENROLLING_BY_INVITATION

Dr. Bernhard Landers

Mayen, , Germany

Site Status ENROLLING_BY_INVITATION

Diabeteszentrum Bogenhausen

München, , Germany

Site Status RECRUITING

Medicover Neu-Ulm MVZ

Neu-Ulm, , Germany

Site Status COMPLETED

Diabetespraxis Oranienburg

Oranienburg, , Germany

Site Status RECRUITING

Diabetesschwerpunktpraxis Dr. Martina Lange

Rheinbach, , Germany

Site Status ENROLLING_BY_INVITATION

Med.Versorgungszentrum Riesa-Dr. Bieler

Riesa, , Germany

Site Status ENROLLING_BY_INVITATION

Dr. med. Carsten Schürfeld, GZ-Vauban

Saarlouis, , Germany

Site Status COMPLETED

Diabetespraxis Schorndorf Dr. Hensel

Schorndorf, , Germany

Site Status RECRUITING

Praxis Dr. Zimmermann

Sonsbeck, , Germany

Site Status ENROLLING_BY_INVITATION

Endokrinologikum Ulm

Ulm, , Germany

Site Status ENROLLING_BY_INVITATION

Diabetespraxis Viersen

Viersen, , Germany

Site Status ENROLLING_BY_INVITATION

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

Milan, Lombardy, Italy

Site Status ENROLLING_BY_INVITATION

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

Turin, Piedmont, Italy

Site Status ENROLLING_BY_INVITATION

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

Livorno, Tuscany, Italy

Site Status RECRUITING

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

Lucca, Tuscany, Italy

Site Status ENROLLING_BY_INVITATION

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, , Italy

Site Status RECRUITING

Azienda Ospedaliera Luigi Sacco

Milan, , Italy

Site Status ENROLLING_BY_INVITATION

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

Naples, , Italy

Site Status ENROLLING_BY_INVITATION

Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia

Perugia, , Italy

Site Status NOT_YET_RECRUITING

DIABETOLOGIA Ravenna AUSL della Romagna

Ravenna, , Italy

Site Status ENROLLING_BY_INVITATION

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

Roma, , Italy

Site Status ENROLLING_BY_INVITATION

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

Rome, , Italy

Site Status ENROLLING_BY_INVITATION

Countries

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Germany Italy

Central Contacts

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Novo Nordisk

Role: CONTACT

(+1) 866-867-7178

Other Identifiers

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U1111-1316-7988

Identifier Type: OTHER

Identifier Source: secondary_id

NN1436-8404

Identifier Type: -

Identifier Source: org_study_id

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