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Diabetes Mellitus, Type 1NCT07160816

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

An observational study of Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 37 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Insulin icodec
How many people
245 participants
Where
37 sitesin 2 countries
Study dates
28 Aug 2025to 20 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

Germany23 sites

  • Zuckerpraxis Dr. Ewald Jammers

    Bramsche, 49565

  • Studiengesellschaft Dres. Könemann/Steinmann GbR

    Bünde, 32257

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

    Dortmund, 44137

  • Diabeteszentrum Duisburg-Mitte

    Duisburg, 47051

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

    Fulda, 36037

  • Gemeinschaftspraxis Dr. Martin Grüneberg

    Herne, 64649

  • Mesut Durmaz, Hof

    Hof, 95030

  • Dr. Carola Lüke

    Jerichow, 39319

  • Diabetespraxis Kiel

    Kiel, 24114

  • Praxis Am Oberen Tor - Dr. Simon-Wagner

    Lichtenfels, 96215

  • Diabetologie Dr. Eidenmüller

    Marburg, 35037

  • Dr. Bernhard Landers

    Mayen, 56727

  • Diabeteszentrum Bogenhausen

    München, 81927

  • Medicover Neu-Ulm MVZ

    Neu-Ulm, 89231

  • Diabetespraxis Oranienburg

    Oranienburg, 16515

  • Hausärztliche und Diabetologische Praxis Pirna

    Pirna, LÄK Sachsen, 01796

  • Diabetesschwerpunktpraxis Dr. Martina Lange

    Rheinbach, 53359

  • Med.Versorgungszentrum Riesa-Dr. Bieler

    Riesa, 01587

  • Dr. med. Carsten Schürfeld, GZ-Vauban

    Saarlouis, 66740

  • Diabetespraxis Schorndorf Dr. Hensel

    Schorndorf, 73614

  • Praxis Dr. Zimmermann

    Sonsbeck, 47665

  • Endokrinologikum Ulm

    Ulm, 89073

  • Diabetespraxis Viersen

    Viersen, 41747

Other trials in Germany

Italy14 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, 88100

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

    Livorno, Tuscany, 57124

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

    Lucca, Tuscany, 55100

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

    Milan, Lombardy, 20121

  • ASST Fatebenefratelli Sacco - Ospedale Macedonio Melloni

    Milan, Lombardy, 20129

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

    Milan, Lombardy, 20132

  • ASST FBF Sacco - Ospedale Luigi Sacco

    Milan, Lombardy, 20157

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

    Naples, 80138

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

    Perugia, 06129

  • DIABETOLOGIA Ravenna AUSL della Romagna

    Ravenna, 48121

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

    Roma, 00161

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

    Rome, 00168

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

    Turin, Piedmont, 10122

Other trials in Italy

About this study

Official title: A Real-world, Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control, Treatment Satisfaction and Adherence Associated With the Use of Insulin Icodec in People Living With Type 1 Diabetes

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.

Being tested
Insulin icodec
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin icodecDrug

    Also called Awiqli

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

Study groups in NCT07160816
Study groupRoleWhat they receive
Insulin icodecParticipants with T1D will be treated with commercially available insulin icodec according to routine clinical practice at the discretion of the treating physician.
Receives: Drug: Insulin icodec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycated haemoglobin (HbA1c)

    Measured as percentage (%) point of HbA1c.

    Measured: Baseline (week 0), week 26

Secondary outcomes (4)

  1. Change in Insulin Treatment Satisfaction Questionnaire (ITSQ) score

    ITSQ measures insulin treatment satisfaction, applicable to a wide range of insulin therapies. The ITSQ consists of 22 items yielding 5 domain scores and a total score. The domains consist of Regimen inconvenience (5 items), Lifestyle flexibility (3 items), Glycemic control (3 items), Hypoglycemic control (5 items), and Satisfaction with the insulin delivery device (6 items). The domain and global ITSQ score both ranges from 0-100.Higher scores indicate a better health state (less negative impact).

    Measured: Baseline (week 0), end of study (week 22-30)

  2. Change in Adelphi Adherence Questionnaire (ADAQ) score

    The ADAQ measure consists of 11 items scored on a scale of 0 to 4. The mean of the individual items represents the total ADAQ score. At least 8 of the 11 items must be answered to calculate the ADAQ score. The lower the score corresponds to the greater adherence.

    Measured: Baseline (week 0), end of study (week 22-30)

  3. Number of self-reported overall severe hypoglycaemia

    Measured as number of episodes.

    Measured: From baseline (week 0) to end of study (week 22-30)

  4. Clinical success as perceived by the physician

    Measured as count of participant per response option.

    Measured: From baseline (week 0) to end of study (week 22-30)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start28 Aug 2025
  3. Primary completion20 Jan 2027 (estimated)
  4. Study completion20 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
245 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07160816
Sponsor's protocol ID
NN1436-8404
Other IDs
U1111-1316-7988
Status last verified
Sep 2026
First submitted
29 Aug 2025
Last updated
25 Sep 2026
Results posted
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycated haemoglobin (HbA1c) (time frame: Baseline (week 0), week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07160816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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