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

July 13, 2021 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

839

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • 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, Iran, Islamic Republic of
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Liraglutide
Patients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks.
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.
Other Names:
  • Victoza®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin A1c (HbA1c) (percentage)
Time Frame: Week 0, week 26
Measured in percentage.
Week 0, week 26
Change in HbA1c (mmol/mol)
Time Frame: Week 0, week 26
Measured in mmol/mol.
Week 0, week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight (kilogram)
Time Frame: Week 0, week 26
Measured in kilogram.
Week 0, week 26
Change in body weight (percentage)
Time Frame: Week 0, week 26
Measured in percentage.
Week 0, week 26
Change in waist circumference
Time Frame: Week 0, week 26
Measured in centimetres.
Week 0, week 26
Change in fasting blood glucose (FBG) (self-measured)
Time Frame: Week 0, week 26
Measured in mg/dL.
Week 0, week 26
Change in total cholesterol (TC)
Time Frame: Week 0, week 26
Measured in mg/dL.
Week 0, week 26
Change in low density lipoprotein cholesterol (LDL-C)
Time Frame: Week 0, week 26
Measured in mg/dL.
Week 0, week 26
Change in high density lipoprotein cholesterol (HDL-C)
Time Frame: Week 0, week 26
Measured in mg/dL.
Week 0, week 26
Change in triglyceride (TG)
Time Frame: Week 0, week 26
Measured in mg/dL.
Week 0, week 26
Change in free fatty acid (FFA)
Time Frame: Week 0, week 26
Measured in mg/dL.
Week 0, week 26
Number of patients permanently discontinuing treatment with Victoza®
Time Frame: Week 26
Number of patients.
Week 26
Reasons for permanent treatment discontinuations
Time Frame: Week 26
Number of occurrence of pre-specified events.
Week 26
Changes in quality of life (EQ-5D index score)
Time Frame: 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.
Week 0, week 26
Changes in quality of life (EQ VAS)
Time Frame: 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.
Week 0, week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2019

Primary Completion (Actual)

October 21, 2020

Study Completion (Actual)

October 21, 2020

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-4438
  • U1111-1213-4238 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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