A Research Study Looking at How Victoza® Works in People With Type 2 Diabetes in Iran, Followed in Local Clinical Routine

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-centre, Prospective, Non-interventional Study Investigating the Effect of Victoza® in Patients With Type 2 Diabetes in Iran Followed in a Real World Setting

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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® Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liraglutide<br>Patients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks. | Drug: Liraglutide<br>* Patients will be treated according to the Iranian label for Victoza®, following routine clinical practice and at the discretion of the study doctor. The study doctor will determine the intended maintenance dose of Victoza®, as well as any changes to the maintenance dose thereafter. Patients will be treated according to the Iranian label for Victoza®, following routine clinical practice and at the discretion of the study doctor. The study doctor will determine the intended maintenance dose of Victoza®, as well as any changes to the maintenance dose thereafter. The physician's decision to initiate treatment with Victoza® is clearly separate from the opportunity to include the patient in the study.<br>* Other names: Victoza®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |