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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1208-5065 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to collect information on how Tresiba® works in real world patients. Patients will get Tresiba® as prescribed to them by their study doctor. The study will last for about 6 to 8 months. Patients will be asked questions about their health and diabetes treatment as part of their normal study doctor's appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tresiba® | Patients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin degludec | Drug | Patients will be treated with commercially available Tresiba® in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the study doctor and in accordance with the local label. The study doctor will determine the starting dose of Tresiba® as well as any dose adjustments thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) (percentage) | Measured in percentage. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used. | Week 0 (baseline), Week 26 (end of study) |
| Change in HbA1c (mmol/mol) | Measured in mmol/mol. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used. | Week 0 (baseline), Week 26 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting plasma glucose (FPG) (mg/dL) | Measured in mg/dL. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with type 2 diabetes in Saudi Arabia treated with any antihyperglycaemic medication(s), except Tresiba®, are eligible for this study.
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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 | AL Qateef | 31911 | Saudi Arabia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36417058 | Derived | AlMalki MH, Aldesokey H, Alkhafaji D, Alsheikh A, Braae UC, Lehrskov LL, Magawry W, Yahia M, Haroun A. Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study-UPDATES Saudi Arabia. Adv Ther. 2023 Feb;40(2):568-584. doi: 10.1007/s12325-022-02366-0. Epub 2022 Nov 22. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Week 0 (baseline), Week 26 (end of study) |
| Change in FPG (mmol/L) | Measured in mmol/L. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used. | Week 0 (baseline), Week 26 (end of study) |
| Change in daily insulin doses: Basal insulin | Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used. | Week 0 (baseline), Week 26 (end of study) |
| Change in daily insulin doses: Prandial insulin | Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used. | Week 0 (baseline), Week 26 (end of study) |
| Change in daily insulin doses: Total insulin | Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used. | Week 0 (baseline), Week 26 (end of study) |
| Change in number of patient reported overall non-severe hypoglycaemic episodes | Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. Non-severe hypoglycaemia is defined as an episode with symptoms and/or self-measured blood glucose (SMBG) value less than or equal to 3.9 mmol/L. | Week -4 to 0, week 22 to 26 |
| Change in number of patient reported nocturnal non-severe hypoglycaemic episodes | Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. The definition of "nocturnal" will be based on the patient's perception of whether or not it was night, i.e. the answer to this question to the patient: "How many of these occurred between midnight and early morning"? | Week -4 to 0, week 22 to 26 |
| Change in number of patient reported severe hypoglycaemic episodes (overall) | Number of episodes occurring within 26 weeks prior to initiation of treatment with Tresiba® and within 26 weeks prior to end of study. Severe hypoglycaemia is defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action. The patient should be asked: "Were you able to treat yourself?", if assistance from another person was required the episode can be defined as severe. | Week -26 to 0, week 0 to 26 |
| Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable | Pre-specified response option(s) after initiation of treatment with Tresiba® until treatment discontinuation. | Week 26 |
| Dammam |
| 32236 |
| Saudi Arabia |
| Novo Nordisk Investigational Site | Dammam | 32253 | Saudi Arabia |
| Novo Nordisk Investigational Site | Dammam | 32263 | Saudi Arabia |
| Novo Nordisk Investigational Site | Ihsa | 36364 | Saudi Arabia |
| Novo Nordisk Investigational Site | Jeddah | 22231 | Saudi Arabia |
| Novo Nordisk Investigational Site | Jeddah | 22252 | Saudi Arabia |
| Novo Nordisk Investigational Site | Jeddah | 22324, | Saudi Arabia |
| Novo Nordisk Investigational Site | Jeddah | 23216 | Saudi Arabia |
| Novo Nordisk Investigational Site | Jeddah | 23521 | Saudi Arabia |
| Novo Nordisk Investigational Site | Jeddah | Saudi Arabia |
| Novo Nordisk Investigational Site | Jubail | 35718 | Saudi Arabia |
| Novo Nordisk Investigational Site | Khobar | 34234 | Saudi Arabia |
| Novo Nordisk Investigational Site | Khobar | 34425 | Saudi Arabia |
| Novo Nordisk Investigational Site | Mecca | 24243 | Saudi Arabia |
| Novo Nordisk Investigational Site | Riyadh | 11525 | Saudi Arabia |
| Novo Nordisk Investigational Site | Riyadh | 12311 | Saudi Arabia |
| Novo Nordisk Investigational Site | Riyadh | 12381 | Saudi Arabia |
| Novo Nordisk Investigational Site | Riyadh | 12625 | Saudi Arabia |
| Novo Nordisk Investigational Site | Riyadh | 14212 | Saudi Arabia |
| Novo Nordisk Investigational Site | Riyadh | 14611 | Saudi Arabia |
| 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 |
|---|---|
| C571886 | insulin degludec |
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