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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1316-7988 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Participants with T1D will be treated with commercially available insulin icodec. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured as percentage (%) point of HbA1c. | Baseline (week 0), week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hausärztliche und Diabetologische Praxis Pirna | Pirna | LÄK Sachsen | 01796 | Germany | ||
| Zuckerpraxis Dr. Ewald Jammers |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Baseline (week 0), end of study (week 22-30) |
| 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. | Baseline (week 0), end of study (week 22-30) |
| Number of self-reported overall severe hypoglycaemia | Measured as number of episodes. | From baseline (week 0) to end of study (week 22-30) |
| Clinical success as perceived by the physician | Measured as count of participant per response option. | From baseline (week 0) to end of study (week 22-30) |
| Bramsche |
| 49565 |
| Germany |
| Studiengesellschaft Dres. Könemann/Steinmann GbR | Bünde | 32257 | Germany |
| Diabeteszentrum-Do Dres. K U. Ch. Busch GbR | Dortmund | 44137 | Germany |
| Diabeteszentrum Duisburg-Mitte | Duisburg | 47051 | Germany |
| MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien | Fulda | 36037 | Germany |
| Gemeinschaftspraxis Dr. Martin Grüneberg | Herne | 64649 | Germany |
| Mesut Durmaz, Hof | Hof | 95030 | Germany |
| Dr. Carola Lüke | Jerichow | 39319 | Germany |
| Diabetespraxis Kiel | Kiel | 24114 | Germany |
| Praxis Am Oberen Tor - Dr. Simon-Wagner | Lichtenfels | 96215 | Germany |
| Diabetologie Dr. Eidenmüller | Marburg | 35037 | Germany |
| Dr. Bernhard Landers | Mayen | 56727 | Germany |
| Diabeteszentrum Bogenhausen | München | 81927 | Germany |
| Medicover Neu-Ulm MVZ | Neu-Ulm | 89231 | Germany |
| Diabetespraxis Oranienburg | Oranienburg | 16515 | Germany |
| Diabetesschwerpunktpraxis Dr. Martina Lange | Rheinbach | 53359 | Germany |
| Med.Versorgungszentrum Riesa-Dr. Bieler | Riesa | 01587 | Germany |
| Dr. med. Carsten Schürfeld, GZ-Vauban | Saarlouis | 66740 | Germany |
| Diabetespraxis Schorndorf Dr. Hensel | Schorndorf | 73614 | Germany |
| Praxis Dr. Zimmermann | Sonsbeck | 47665 | Germany |
| Endokrinologikum Ulm | Ulm | 89073 | Germany |
| Diabetespraxis Viersen | Viersen | 41747 | Germany |
| ASST FBF Sacco - Ospedale Fatebenefratelli e Oftalmico - Oculistica - Istituto Oftalmico | Milan | Lombardy | 20121 | Italy |
| ASST Fatebenefratelli Sacco - Ospedale Macedonio Melloni | Milan | Lombardy | 20129 | Italy |
| Ospedale San Raffaele S.r.l. - Unità Clinica Endocrinologia | Milan | Lombardy | 20132 | Italy |
| ASST FBF Sacco - Ospedale Luigi Sacco | Milan | Lombardy | 20157 | Italy |
| Azienda Sanitaria Locale Città di Torino - Ambulatorio Endocrinologia e Malattie Metaboliche | Turin | Piedmont | 10122 | Italy |
| AUSL Toscana Nord Ovest - Ospedali Riuniti di Livorno - Diabetologia e Malattie del Metabolismo | Livorno | Tuscany | 57124 | Italy |
| AUSL Toscana Nord Ovest - Cittadella della Salute Campo di Marte - Diabetologia Lucca e Valle del Serchio | Lucca | Tuscany | 55100 | Italy |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Azienda Ospedaliero-Universitaria Renato Dulbecco | Catanzaro | 88100 | Italy |
| A.O.U. Università Studi della Campania "Luigi Vanvitelli" | Naples | 80138 | Italy |
| Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia | Perugia | 06129 | Italy |
| DIABETOLOGIA Ravenna AUSL della Romagna | Ravenna | 48121 | Italy |
| Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale | Roma | 00161 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche | Rome | 00168 | Italy |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000712207 | insulin icodec |
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