| Trial ID: | L6109 |
| Source ID: | NCT03785522
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| Associated Drug: |
Insulin Degludec
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| Title: |
A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Saudi Arabia
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| Acronym: |
UPDATES
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Insulin degludec
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| Outcome Measures: |
Primary: 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) | Secondary: 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., 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
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
597
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| Study Type: |
OBSERVATIONAL
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| Study Designs: |
Observational Model: |Time Perspective: p
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| Start Date: |
2018-12-23
|
| Completion Date: |
2020-11-30
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| Results First Posted: |
|
| Last Update Posted: |
2021-06-04
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| Locations: |
Novo Nordisk Investigational Site, Al Jubayl, 35718, Saudi Arabia|Novo Nordisk Investigational Site, Al Khobar, 34234, Saudi Arabia|Novo Nordisk Investigational Site, Al Khobar, 34425, Saudi Arabia|Novo Nordisk Investigational Site, AL Qateef, 31911, Saudi Arabia|Novo Nordisk Investigational Site, 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, Makkah, 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
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| URL: |
https://clinicaltrials.gov/show/NCT03785522
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