| Trial ID: | L2422 |
| Source ID: | NCT03888157
|
| Associated Drug: |
Liraglutide
|
| Title: |
A Research Study Looking at How Victoza® Works in People With Type 2 Diabetes in Iran, Followed in Local Clinical Routine
|
| Acronym: |
VIEW-Iran
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Liraglutide
|
| Outcome Measures: |
Primary: Change in glycated haemoglobin A1c (HbA1c) (percentage), Measured in percentage., Week 0, week 26|Change in HbA1c (mmol/mol), Measured in mmol/mol., Week 0, week 26 | Secondary: Change in body weight (kilogram), Measured in kilogram., Week 0, week 26|Change in body weight (percentage), Measured in percentage., Week 0, week 26|Change in waist circumference, Measured in centimetres., Week 0, week 26|Change in fasting blood glucose (FBG) (self-measured), Measured in mg/dL., Week 0, week 26|Change in total cholesterol (TC), Measured in mg/dL., Week 0, week 26|Change in low density lipoprotein cholesterol (LDL-C), Measured in mg/dL., Week 0, week 26|Change in high density lipoprotein cholesterol (HDL-C), Measured in mg/dL., Week 0, week 26|Change in triglyceride (TG), Measured in mg/dL., Week 0, week 26|Change in free fatty acid (FFA), Measured in mg/dL., Week 0, week 26|Number of patients permanently discontinuing treatment with Victoza®, Number of patients., Week 26|Reasons for permanent treatment discontinuations, Number of occurrence of pre-specified events., Week 26|Changes in quality of life (EQ-5D index score), Quality of life will be measured with the EQ-5D-5L instrument's index score. The EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems). The outcome will be presented as EQ-5D index values using the United Kingdom (UK) value set., Week 0, week 26|Changes in quality of life (EQ VAS), Quality of life will be measured by EQ-5D-5L instrument's EQ visual analogue scale (EQ VAS). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scale is numbered from 0 to 100, where 0 indicates "worst" and 100 indicates "best". The outcome will be presented as EQ-5D VAS scores., Week 0, week 26
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
839
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2019-03-10
|
| Completion Date: |
2020-10-21
|
| Results First Posted: |
|
| Last Update Posted: |
2021-07-14
|
| Locations: |
Novo Nordisk Investigational Site, Ahvaz, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Ardabil, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Babol, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Gorgan, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Hamedan, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Hormozgan, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Isfahan, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Islamshahr, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Karaj, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Kerman, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Mashad, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Mashahd, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Mashhad, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Sari, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Shiraz, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Tehran, Iran, Islamic Republic of|Novo Nordisk Investigational Site, Yazd, Iran, Islamic Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT03888157
|
