Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 399 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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 11, 2019
First Posted Date March 25, 2019
Last Update Posted Date November 13, 2019
Actual Study Start Date March 10, 2019
Estimated Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 21, 2019)
  • Change in glycated haemoglobin A1c (HbA1c) (percentage) [ Time Frame: Week 0, week 26 ]
    Measured in percentage.
  • Change in HbA1c (mmol/mol) [ Time Frame: Week 0, week 26 ]
    Measured in mmol/mol.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03888157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 21, 2019)
  • Change in body weight (kilogram) [ Time Frame: Week 0, week 26 ]
    Measured in kilogram.
  • Change in body weight (percentage) [ Time Frame: Week 0, week 26 ]
    Measured in percentage.
  • Change in waist circumference [ Time Frame: Week 0, week 26 ]
    Measured in centimetres.
  • Change in fasting blood glucose (FBG) (self-measured) [ Time Frame: Week 0, week 26 ]
    Measured in mg/dL.
  • Change in total cholesterol (TC) [ Time Frame: Week 0, week 26 ]
    Measured in mg/dL.
  • Change in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Week 0, week 26 ]
    Measured in mg/dL.
  • Change in high density lipoprotein cholesterol (HDL-C) [ Time Frame: Week 0, week 26 ]
    Measured in mg/dL.
  • Change in triglyceride (TG) [ Time Frame: Week 0, week 26 ]
    Measured in mg/dL.
  • Change in free fatty acid (FFA) [ Time Frame: Week 0, week 26 ]
    Measured in mg/dL.
  • Number of patients permanently discontinuing treatment with Victoza® [ Time Frame: Week 26 ]
    Number of patients.
  • Reasons for permanent treatment discontinuations [ Time Frame: Week 26 ]
    Number of occurrence of pre-specified events.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Research Study Looking at How Victoza® Works in People With Type 2 Diabetes in Iran, Followed in Local Clinical Routine
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Diabetes Mellitus, Type 2
Intervention 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®
Study Groups/Cohorts Liraglutide
Patients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks.
Intervention: Drug: Liraglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: March 21, 2019)
830
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 14, 2020
Estimated Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03888157
Other Study ID Numbers NN2211-4438
U1111-1213-4238 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2019