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Completed

NCT Number: NCT03888157

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Ahvāz, Iran

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

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.

Other names: Victoza®

Primary outcomes

  1. Change in glycated haemoglobin A1c (HbA1c) (percentage)

    Time frame: Week 0, week 26

    Measured in percentage.

  2. Change in HbA1c (mmol/mol)

    Time frame: Week 0, week 26

    Measured in mmol/mol.

Secondary outcomes

  1. Change in body weight (kilogram)

    Time frame: Week 0, week 26

    Measured in kilogram.

  2. Change in body weight (percentage)

    Time frame: Week 0, week 26

    Measured in percentage.

  3. Change in waist circumference

    Time frame: Week 0, week 26

    Measured in centimetres.

  4. Change in fasting blood glucose (FBG) (self-measured)

    Time frame: Week 0, week 26

    Measured in mg/dL.

  5. Change in total cholesterol (TC)

    Time frame: Week 0, week 26

    Measured in mg/dL.

  6. Change in low density lipoprotein cholesterol (LDL-C)

    Time frame: Week 0, week 26

    Measured in mg/dL.

  7. Change in high density lipoprotein cholesterol (HDL-C)

    Time frame: Week 0, week 26

    Measured in mg/dL.

  8. Change in triglyceride (TG)

    Time frame: Week 0, week 26

    Measured in mg/dL.

  9. Change in free fatty acid (FFA)

    Time frame: Week 0, week 26

    Measured in mg/dL.

  10. Number of patients permanently discontinuing treatment with Victoza®

    Time frame: Week 26

    Number of patients.

  11. Reasons for permanent treatment discontinuations

    Time frame: Week 26

    Number of occurrence of pre-specified events.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: VIEW-Iran

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 25, 2019
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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