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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1213-4338 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to collect information on how Xultophy® works in patients with type 2 diabetes. The participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26-34 weeks. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with type 2 diabetes (T2DM) | Patients with T2DM treated with any basal insulin or glucagon-Like peptide-1 receptor agonist (GLP-1 RA) (including once weekly GLP-1 RA) with/without oral antidiabetic drug (OAD) treatment, and with inadequate glycaemic control, for whom the physician had decided to intensify their treatment with Xultophy® |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin degludec/liraglutide | Drug | Patients will be treated with Insulin degludec/liraglutide (Xultophy®) at the treating physician's discretion and independent from the decision to include the patient in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in laboratory measured glycosylated haemoglobin A1c (HbA1c) | Measured in % point | From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients reached HbA1c less than 7% at end of study (Yes/No ) | Number of patients who achieved/not achieved HbA1c at end of study: <7.0% | At the end of study visit (26-34 weeks) |
| Change in laboratory measured fasting plasma glucose (FPG) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with Type 2 Diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Abu Dhabi | United Arab Emirates | ||||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Measured in mg/dL
| From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) |
| Average dose step of Xultophy® at end of the study | Measured in dose steps/day | At the end of study (26-34 weeks) |
| Change of body weight | Measured in kg | From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) |
| Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection | Number of episodes | Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks) |
| Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection | Number of episodes | Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks) |
| Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall) | Number of episodes | Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 26 weeks prior to initiation of treatment with Xultophy® and to within 26 weeks prior to end of study (26-34 weeks) |
| Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable | Pre-specified response option(s) | At the end of study (26-34 weeks) |
| Ajman |
| 4184 |
| United Arab Emirates |
| Novo Nordisk Investigational Site | Dubai | United Arab Emirates |
| 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 |
|---|---|
| C000613158 | IDegLira |
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