A Research Study Looking at How Victoza® Works in People With Type 2 Diabetes in Iran, Followed in Local Clinical Routine
- Registration Number
- NCT03888157
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
The purpose of the study is to collect information on how the medicine Victoza® (liraglutide) works in people with Type 2 diabetes in Iran. Patients will get Victoza® as prescribed to them by their study doctor. The study will last for about 5 to 8 months. Patients will be asked to complete some questionnaires about their health and diabetes treatment. Patients will complete these during their normally scheduled visits with study doctor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 839
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- The decision to initiate treatment with commercially available Victoza® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
- Patients diagnosed with type 2 diabetes mellitus (T2DM), with treatment planned according to the Iranian label for Victoza® at treatment initiation
- Available glycated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of treatment with Victoza®
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Known or suspected hypersensitivity to Victoza® or related products
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Liraglutide Liraglutide Patients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks.
- Primary Outcome Measures
Name Time Method Change in HbA1c (mmol/mol) Week 0, week 26 Measured in mmol/mol.
Change in glycated haemoglobin A1c (HbA1c) (percentage) Week 0, week 26 Measured in percentage.
- Secondary Outcome Measures
Name Time Method Number of patients permanently discontinuing treatment with Victoza® Week 26 Number of patients.
Reasons for permanent treatment discontinuations Week 26 Number of occurrence of pre-specified events.
Change in body weight (percentage) Week 0, week 26 Measured in percentage.
Change in body weight (kilogram) Week 0, week 26 Measured in kilogram.
Change in fasting blood glucose (FBG) (self-measured) Week 0, week 26 Measured in mg/dL.
Change in total cholesterol (TC) Week 0, week 26 Measured in mg/dL.
Change in high density lipoprotein cholesterol (HDL-C) Week 0, week 26 Measured in mg/dL.
Change in low density lipoprotein cholesterol (LDL-C) Week 0, week 26 Measured in mg/dL.
Change in waist circumference Week 0, week 26 Measured in centimetres.
Change in triglyceride (TG) Week 0, week 26 Measured in mg/dL.
Change in free fatty acid (FFA) Week 0, week 26 Measured in mg/dL.
Changes in quality of life (EQ-5D index score) Week 0, week 26 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.
Changes in quality of life (EQ VAS) Week 0, week 26 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.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇮🇷Yazd, Iran, Islamic Republic of