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Active, not recruiting Observational

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

NCT07160816 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2025-08-28
Last updated
2026-09-25

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

Insulin icodec →

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in glycated haemoglobin (HbA1c) — Baseline (week 0), week 26
    Measured as percentage (%) point of HbA1c.

Trial sites (37)

FacilityCityRegionStatus
Hausärztliche und Diabetologische Praxis Pirna Pirna LÄK Sachsen
Zuckerpraxis Dr. Ewald Jammers Bramsche Germany
Studiengesellschaft Dres. Könemann/Steinmann GbR Bünde Germany
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR Dortmund Germany
Diabeteszentrum Duisburg-Mitte Duisburg Germany
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien Fulda Germany
Gemeinschaftspraxis Dr. Martin Grüneberg Herne Germany
Mesut Durmaz, Hof Hof Germany
Dr. Carola Lüke Jerichow Germany
Diabetespraxis Kiel Kiel Germany
Praxis Am Oberen Tor - Dr. Simon-Wagner Lichtenfels Germany
Diabetologie Dr. Eidenmüller Marburg Germany
Dr. Bernhard Landers Mayen Germany
Diabeteszentrum Bogenhausen München Germany
Medicover Neu-Ulm MVZ Neu-Ulm Germany
Diabetespraxis Oranienburg Oranienburg Germany
Diabetesschwerpunktpraxis Dr. Martina Lange Rheinbach Germany
Med.Versorgungszentrum Riesa-Dr. Bieler Riesa Germany
Dr. med. Carsten Schürfeld, GZ-Vauban Saarlouis Germany
Diabetespraxis Schorndorf Dr. Hensel Schorndorf Germany
Praxis Dr. Zimmermann Sonsbeck Germany
Endokrinologikum Ulm Ulm Germany
Diabetespraxis Viersen Viersen Germany
ASST FBF Sacco - Ospedale Fatebenefratelli e Oftalmico - Oculistica - Istituto Oftalmico Milan Lombardy
ASST Fatebenefratelli Sacco - Ospedale Macedonio Melloni Milan Lombardy
Ospedale San Raffaele S.r.l. - Unità Clinica Endocrinologia Milan Lombardy
ASST FBF Sacco - Ospedale Luigi Sacco Milan Lombardy
Azienda Sanitaria Locale Città di Torino - Ambulatorio Endocrinologia e Malattie Metaboliche Turin Piedmont
AUSL Toscana Nord Ovest - Ospedali Riuniti di Livorno - Diabetologia e Malattie del Metabolismo Livorno Tuscany
AUSL Toscana Nord Ovest - Cittadella della Salute Campo di Marte - Diabetologia Lucca e Valle del Serchio Lucca Tuscany
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco Catanzaro Italy
A.O.U. Università Studi della Campania "Luigi Vanvitelli" Naples Italy
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia Perugia Italy
DIABETOLOGIA Ravenna AUSL della Romagna Ravenna Italy
Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale Roma Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche Rome Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07160816 on ClinicalTrials.gov ↗ ← All trials in Germany