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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1328-4272 | Other Identifier | World Health Organization (WHO) |
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The purpose of this study is to investigate the use of insulin icodec in the real-world setting in a population that broadly reflects people living with T2D and for whom switching to a once-weekly insulin icodec has been deemed relevant and beneficial by the treating physician. The study will last for approximately 30 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icodec with/without non-insulin glucose lowering treatments | Participants will initiate the treatment with insulin icodec at the treating physician's discretion according to the local label, and it will be clearly separated from the decision to include the participant in the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Participants will initiate the treatment with insulin icodec at the treating physician's discretion according to the local label, and it will be clearly separated from the decision to include the participant in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured in percentage (%)-point | From baseline (week 0) to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score | The DTSQs measures how satisfied patients are with their current diabetes treatment. It consists of 8 questions, rated on a Likert scale from 0 to 6 (0 = verydissatisfied to 6 = very satisfied). Six questions are summed to produce a total TreatmentSatisfaction score. Transformed to a 0-100 scale with higher scores indicating a higher treatment satisfaction. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult participants (≥18 years) with type 2 diabetes who have been diagnosed for at least one year and are currently being treated with once- or twice-daily basal insulin. The study includes approximately 216 participants across multiple centres in Canada, Italy, and China, reflecting a real-world population of individuals with type 2 diabetes receiving standard clinical care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China | ||
| The Second Affiliated Hospital of Chongqing Medical University-Endocrinology |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| From baseline (week 0) to End of study (week 22-30) |
| Change in Adelphi Adherence Questionnaire (ADAQ) score | The ADAQ measures medication adherence. The measure consists of 11 items, all of which are scored from 0 to 4. At least 8 of the 11 items must be completed to calculate the ADAQ score. The ADAQ score is calculated as the mean of the completed item scores. The lower the score, the greater the adherence. | From baseline (week 0) to End of study (week 22-30) |
| Change in body weight | Measured in kilograms (kg). | From baseline (week 0) to week 26 |
| Number of self-reported overall severe hypoglycemia episodes | Measured in number of episodes. | From baseline (week 0) to end of study (week 22-30) |
| Chongqing |
| Chongqing Municipality |
| 400010 |
| China |
| Gansu Provincial People's Hospital | Lanzhou | Gansu | 730000 | China |
| The People's Hospital of JiangMen | Jiangmen | Guangdong | 529020 | China |
| Hebei PetroChina Central Hospital | Langfang | Hebi | 065099 | China |
| Heilongjiang Provincial Hospital | Harbin | Heilongjiang | 150036 | China |
| Shiyan City People's Hospital | Shiyan | Hubei | 442099 | China |
| NIS-Huai'an First People's Hospital-Endocrinology | Huai'an | Jiangsu | 223300 | China |
| NIS-Nanjing Jiangning Hospital-Endocrinology | Nanjing | Jiangsu | 211199 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The Fifth People's Hospital of Shenyang | Shenyang | Liaoning | 110023 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250098 | China |
| Tongren Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200050 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Urumuqi | Xinjiang | 830054 | China |
| 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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