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Trial record 6 of 396 for:    LIRAGLUTIDE

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

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ClinicalTrials.gov Identifier: NCT03888157
Recruitment Status : Enrolling by invitation
First Posted : March 25, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Liraglutide

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Study Type : Observational
Estimated Enrollment : 830 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : March 10, 2019
Estimated Primary Completion Date : April 14, 2020
Estimated Study Completion Date : August 14, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

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 Name: Victoza®




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888157


Locations
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Iran, Islamic Republic of
Novo Nordisk Investigational Site
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
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03888157     History of Changes
Other Study ID Numbers: NN2211-4438
U1111-1213-4238 ( Other Identifier: World Health Organization (WHO) )
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com/sharing-results

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liraglutide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists