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

Novo Nordisk A/S839 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

839

Conditions

Diabetes Mellitus, Type 2

Interventions

LiraglutideDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Novo Nordisk Investigational Site

Ahvāz, Iran

Novo Nordisk Investigational Site

Ardabil, Iran

Novo Nordisk Investigational Site

Babol, Iran

Outcomes

Primary Outcomes

Change in glycated haemoglobin A1c (HbA1c) (percentage)

Measured in percentage.

Time frame: Week 0, week 26

Change in HbA1c (mmol/mol)

Measured in mmol/mol.

Time frame: Week 0, week 26

Secondary Outcomes

Change in body weight (kilogram)

Measured in kilogram.

Time frame: Week 0, week 26

Change in body weight (percentage)

Measured in percentage.

Time frame: Week 0, week 26

Change in waist circumference

Measured in centimetres.

Time frame: Week 0, week 26

Change in fasting blood glucose (FBG) (self-measured)

Measured in mg/dL.

Time frame: Week 0, week 26

Change in total cholesterol (TC)

Measured in mg/dL.

Time frame: Week 0, week 26

Change in low density lipoprotein cholesterol (LDL-C)

Measured in mg/dL.

Time frame: Week 0, week 26

Change in high density lipoprotein cholesterol (HDL-C)

Measured in mg/dL.

Time frame: Week 0, week 26

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.