Clinical trial NCT03888157: A Research Study Looking at How Victoza® Works in People With Type 2 Diabetes in Iran, Followed in Local Clinical Routine
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-03-25
Enrollment: 839
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with T2DM in Iran judged by the study doctor for whom Victoza® is indicated are eligible to participate in the study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in glycated haemoglobin A1c (HbA1c) (percentage)
timeFrame: Week 0, week 26
measure: Change in HbA1c (mmol/mol)
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Change in body weight (kilogram)
timeFrame: Week 0, week 26
measure: Change in body weight (percentage)
timeFrame: Week 0, week 26
measure: Change in waist circumference
timeFrame: Week 0, week 26
measure: Change in fasting blood glucose (FBG) (self-measured)
timeFrame: Week 0, week 26
measure: Change in total cholesterol (TC)
timeFrame: Week 0, week 26
measure: Change in low density lipoprotein cholesterol (LDL-C)
timeFrame: Week 0, week 26
measure: Change in high density lipoprotein cholesterol (HDL-C)
timeFrame: Week 0, week 26
measure: Change in triglyceride (TG)
timeFrame: Week 0, week 26
measure: Change in free fatty acid (FFA)
timeFrame: Week 0, week 26
measure: Number of patients permanently discontinuing treatment with Victoza®
timeFrame: Week 26
measure: Reasons for permanent treatment discontinuations
timeFrame: Week 26
measure: Changes in quality of life (EQ-5D index score)
timeFrame: Week 0, week 26
measure: Changes in quality of life (EQ VAS)
timeFrame: Week 0, week 26
Other outcomes:
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Ardabil
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Babol
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Gorgan
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Hamedan
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Hormozgan
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Isfahan
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Islamshahr
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Karaj
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Kerman
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Mashad
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Mashahd
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Mashhad
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Sari
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Shiraz
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Tehran
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
city: Yazd
country: Iran, Islamic Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: