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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1328-4242 | 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 2 diabetes (T2D) 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 T2D 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 T2D 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 Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score | DTSQs measures how satisfied participants are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). 6 items are scored on a scale of 1 to 7 across 5 different domains and transformed to a 0-100 scale. Higher scores indicate a higher treatment satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population comprises participants who are diagnosed with type 2 diabetes and agree to be treated with insulin icodec after consultation with their physician independently from the decision to participate in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria Locale Di Pescara | Pescara | Abruzzo | 65124 | Italy | ||
| Azienda Ospedaliera-Universitaria Di Cosenza |
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) |
| Change in body weight | Measured as kilogram (kg). | Baseline (week 0), week 26 |
| Number of self-reported overall severe hypoglycemia episodes | Measured as number of episodes. | From baseline (week 0) to end of study (week 22-30) |
| Frequency of titrations | Measured as weeks. | From baseline (week 0) to end of study (week 22-30) |
| Titration increments/decrements per titration | Measured as unit. | From baseline (week 0) to end of study (week 22-30) |
| San Giovanni in Fiore (CS) |
| Calabria |
| 87027 |
| Italy |
| Azienda Sanitaria Locale Napoli 2 Nord | Marano Di Napoli (NA) | Campania | 80016 | Italy |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata | Rome | Lazio | 00133 | Italy |
| Policlinico Casilino | Rome | Lazio | 00169 | Italy |
| Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Medicina interna | Rome | Lazio | 00189 | Italy |
| Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo | Milan | Lombardy | 20142 | Italy |
| Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia | Milan | Lombardy | 20159 | Italy |
| Azienda Ospedaliera Santa Croce E Carle | Cuneo | Piedmont | 12100 | Italy |
| ARNAS Garibaldi Catania | Catania | Sicily | 95123 | Italy |
| Ospedale centrale L. Bohler Bolzano | Bolzano | Trentino-Alto Adige | 39100 | Italy |
| Azienda Ospedaliera di Padova | Padova | Veneto | 35128 | Italy |
| Ospedale di Città di Castello | Città di Castello | 06012 | Italy |
| ASL Avellino | Montoro | 83026 | Italy |
| Ospedale Generale provinciale | Province of Macerata | 62100 | Italy |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000712207 | insulin icodec |
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