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

Diabetes Mellitus, Type 2 Clinical Trial

— VIEW-Iran  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888157
• Other study ID #: NN2211-4438
• Secondary ID: U1111-1213-4238
• Status: Completed
• Start date: March 10, 2019
• Est. completion date: October 21, 2020

Study information

• Verified date: July 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: October 21, 2020
• Est. primary completion date: October 21, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Liraglutide
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycated haemoglobin A1c (HbA1c) (percentage)	Measured in percentage.	Week 0, week 26
Primary	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
Secondary	Change in body weight (percentage)	Measured in percentage.	Week 0, week 26
Secondary	Change in waist circumference	Measured in centimetres.	Week 0, week 26
Secondary	Change in fasting blood glucose (FBG) (self-measured)	Measured in mg/dL.	Week 0, week 26
Secondary	Change in total cholesterol (TC)	Measured in mg/dL.	Week 0, week 26
Secondary	Change in low density lipoprotein cholesterol (LDL-C)	Measured in mg/dL.	Week 0, week 26
Secondary	Change in high density lipoprotein cholesterol (HDL-C)	Measured in mg/dL.	Week 0, week 26
Secondary	Change in triglyceride (TG)	Measured in mg/dL.	Week 0, week 26
Secondary	Change in free fatty acid (FFA)	Measured in mg/dL.	Week 0, week 26
Secondary	Number of patients permanently discontinuing treatment with Victoza®	Number of patients.	Week 26
Secondary	Reasons for permanent treatment discontinuations	Number of occurrence of pre-specified events.	Week 26
Secondary	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
Secondary	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