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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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