| Trial ID: | L3687 |
| Source ID: | NCT04892069
|
| Associated Drug: |
Insulin Degludec/Insulin Aspart
|
| Title: |
Investigating the Effect of Ryzodeg® in Adult Patients With Type 2 Diabetes in Lebanon
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin Degludec/Insulin Aspart
|
| Outcome Measures: |
Primary: Change in Glycated Haemoglobin (HbA1c), Percent (%) point. For all primary and secondary outcome measures: Baseline values for effect assessment will be collected as close to and prior to Ryzodeg® initiation as possible (week 0) but none of these values may be more than 12 weeks old. For end of study a window of 6 weeks before and after week 26 is used., From baseline (defined as the time of Ryzodeg® initiation (week -12 to week 0)) to end-of-study (week 26 +/- 6 weeks) | Secondary: HbA1c less than 7%, Percentage of patients, At end-of-study week 26|HbA1c less than 7% without any severe hypoglycaemic episodes during period 2 (26 weeks after initiation of Ryzodeg®), Percentage of patients, At end-of-study week 26|Change in fasting plasma glucose (FPG), mmol/L, From baseline to end-of-study week 26|Change in insulin dose (total, basal, prandial), units/day, From baseline to end-of-study week 26|Change in body weight, Kilogram (Kg), From baseline to end-of-study week 26|Change in the occurrence of severe hypoglycaemic events before and after initiation of treatment, Number of patients experiencing severe hypoglycaemic events in period 1 versus period 2. Period 1 is defined as 26 weeks prior to initiation of Ryzodeg® and period 2 is defined as 26 weeks after initiation of Ryzodeg®., From week -26 to week 26
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
60
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2021-05-27
|
| Completion Date: |
2021-11-18
|
| Results First Posted: |
|
| Last Update Posted: |
2022-11-14
|
| Locations: |
Novo Nordisk Investigational Site, Beirut, Hamra, Beirut, 00000, Lebanon
|
| URL: |
https://clinicaltrials.gov/show/NCT04892069
|
