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

NCT ID: NCT03888157

Last Updated: 2021-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

839 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-10

Study Completion Date

2020-10-21

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liraglutide

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

Liraglutide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Victoza®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Ahvāz, , Iran

Site Status

Novo Nordisk Investigational Site

Ardabil, , Iran

Site Status

Novo Nordisk Investigational Site

Babol, , Iran

Site Status

Novo Nordisk Investigational Site

Gorgan, , Iran

Site Status

Novo Nordisk Investigational Site

Hamadan, , Iran

Site Status

Novo Nordisk Investigational Site

Hormozgan, , Iran

Site Status

Novo Nordisk Investigational Site

Isfahan, , Iran

Site Status

Novo Nordisk Investigational Site

Islamshahr, , Iran

Site Status

Novo Nordisk Investigational Site

Karaj, , Iran

Site Status

Novo Nordisk Investigational Site

Kerman, , Iran

Site Status

Novo Nordisk Investigational Site

Mashahd, , Iran

Site Status

Novo Nordisk Investigational Site

Mashhad, , Iran

Site Status

Novo Nordisk Investigational Site

Sari, , Iran

Site Status

Novo Nordisk Investigational Site

Shiraz, , Iran

Site Status

Novo Nordisk Investigational Site

Tehran, , Iran

Site Status

Novo Nordisk Investigational Site

Yazd, , Iran

Site Status

Countries

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Iran

Other Identifiers

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U1111-1213-4238

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-4438

Identifier Type: -

Identifier Source: org_study_id

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