NCT03888157|Completed

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

VIEW-Iran

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN2211-4438U1111-1213-4238

Study Type

observational

Target

839

Locations

1 country

Sites

Timeline

RegisteredMar 2019

StartedMar 2019

CompletionOct 2020

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

839

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2019

Geographic Reach

1 country

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

March 10, 2019

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed

14 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed

Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

March 11, 2019

Last Update Submit

July 13, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Change in glycated haemoglobin A1c (HbA1c) (percentage)
Measured in percentage.
Week 0, week 26
Change in HbA1c (mmol/mol)
Measured in mmol/mol.
Week 0, week 26

Secondary Outcomes (13)

Change in body weight (kilogram)
Week 0, week 26
Change in body weight (percentage)
Week 0, week 26
Change in waist circumference
Week 0, week 26
Change in fasting blood glucose (FBG) (self-measured)
Week 0, week 26
Change in total cholesterol (TC)
Week 0, week 26
+8 more secondary outcomes

Study Arms (1)

Liraglutide

Patients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks.

Drug: Liraglutide

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.

Also known as: Victoza®

Liraglutide

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

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®

You may not qualify if:

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

Contact the study team to confirm eligibility.