| Trial ID: | L5542 |
| Source ID: | NCT04656106
|
| Associated Drug: |
Ryzodeg®
|
| Title: |
A Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea
|
| Acronym: |
|
| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Ryzodeg®
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| Outcome Measures: |
Primary: Change in HbA1c (Glycosylated Hemoglobin), Percentage point, Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | Secondary: Patients with HbA1c less than 7.0 percentage (Yes or No), Percentage of patients, At baseline (week 0)|Patients with HbA1c less than 7.0 percentage (Yes or No), Percentage of patients, End of study (week 26)|Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No), Percentage of patients, At baseline (week 0)|Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No), Percentage of patients, End of study (week 26)|Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®, Number of events, Period 1(week-26 to week 0), Period 2(week 0 to week 26)|Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®, Number of events, Period 1(week-26 to week 0), Period 2(week 0 to week 26)|Change in FPG (Fasting Plasma Glucose), mmol/L, Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)|Change in daily total insulin dose, Unit/day, Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)|Change in daily basal insulin dose, Unit/day, Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)|Change in daily prandial insulin dose, Unit/day, Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)|Change in body weight, Kg, Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
200
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2021-04-27
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| Completion Date: |
2021-07-01
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| Results First Posted: |
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| Last Update Posted: |
2021-09-28
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| Locations: |
Novo Nordisk Investigational Site, Daejeon, 330-721, Korea, Republic of|Novo Nordisk Investigational Site, Daejeon, 361-711, Korea, Republic of|Novo Nordisk Investigational Site, Seongnam-si, 463-707, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 03181, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 06273, Korea, Republic of|Novo Nordisk Investigational Site, Suwon-si, Gyeonggi-do, 16247, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT04656106
|
