Diabetes Mellitus, Type 2VIEW-IranNCT03888157
A Research Study Looking at How Victoza® Works in People With Type 2 Diabetes in Iran, Followed in Local Clinical Routine
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 16 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Liraglutide
- How many people
- 839 participants
- Where
- 16 sitesIran
- Study dates
- 10 Mar 2019to 21 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with T2DM in Iran judged by the study doctor for whom Victoza® is indicated are eligible to participate in the study.
Who may be able to join
- 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®
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Iran16 sites
Novo Nordisk Investigational Site
Ahvāz
Novo Nordisk Investigational Site
Ardabil
Novo Nordisk Investigational Site
Babol
Novo Nordisk Investigational Site
Gorgan
Novo Nordisk Investigational Site
Hamadan
Novo Nordisk Investigational Site
Hormozgan
Novo Nordisk Investigational Site
Isfahan
Novo Nordisk Investigational Site
Islamshahr
Novo Nordisk Investigational Site
Karaj
Novo Nordisk Investigational Site
Kerman
Novo Nordisk Investigational Site
Mashahd
Novo Nordisk Investigational Site
Mashhad
Novo Nordisk Investigational Site
Sari
Novo Nordisk Investigational Site
Shiraz
Novo Nordisk Investigational Site
Tehran
Novo Nordisk Investigational Site
Yazd
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Liraglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza®
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.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Patients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks. Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin A1c (HbA1c) (percentage)
Measured in percentage.
Measured: Week 0, week 26
Change in HbA1c (mmol/mol)
Measured in mmol/mol.
Measured: Week 0, week 26
Secondary outcomes (13)
Change in body weight (kilogram)
Measured in kilogram.
Measured: Week 0, week 26
Change in body weight (percentage)
Measured in percentage.
Measured: Week 0, week 26
Change in waist circumference
Measured in centimetres.
Measured: Week 0, week 26
Change in fasting blood glucose (FBG) (self-measured)
Measured in mg/dL.
Measured: Week 0, week 26
Change in total cholesterol (TC)
Measured in mg/dL.
Measured: Week 0, week 26
Change in low density lipoprotein cholesterol (LDL-C)
Measured in mg/dL.
Measured: Week 0, week 26
Change in high density lipoprotein cholesterol (HDL-C)
Measured in mg/dL.
Measured: Week 0, week 26
Change in triglyceride (TG)
Measured in mg/dL.
Measured: Week 0, week 26
Change in free fatty acid (FFA)
Measured in mg/dL.
Measured: Week 0, week 26
Number of patients permanently discontinuing treatment with Victoza®
Number of patients.
Measured: Week 26
Reasons for permanent treatment discontinuations
Number of occurrence of pre-specified events.
Measured: Week 26
Changes in quality of life (EQ-5D index score)
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.
Measured: Week 0, week 26
Changes in quality of life (EQ VAS)
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.
Measured: Week 0, week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start10 Mar 2019
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888157
- Sponsor's protocol ID
- NN2211-4438
- Other IDs
- U1111-1213-4238
- Acronym
- VIEW-Iran
- Status last verified
- Jul 2021
- First submitted
- 11 Mar 2019
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03888157
- Acronym / sponsor ID
- VIEW-Iran / NN2211-4438
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | – | Drug: LiraglutidePatients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with T2DM in Iran judged by the study doctor for whom Victoza® is indicated are eligible to participate in the study.
Key inclusion criteria (5 listed)
- 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®
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: Victoza®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. | Drug | Liraglutide |
Primary outcome
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.
13 secondary outcomes
Change in body weight (kilogram)
Time frame: Week 0, week 26
Change in body weight (percentage)
Time frame: Week 0, week 26
Change in waist circumference
Time frame: Week 0, week 26
Change in fasting blood glucose (FBG) (self-measured)
Time frame: Week 0, week 26
Change in total cholesterol (TC)
Time frame: Week 0, week 26
Change in low density lipoprotein cholesterol (LDL-C)
Time frame: Week 0, week 26
Change in high density lipoprotein cholesterol (HDL-C)
Time frame: Week 0, week 26
Change in triglyceride (TG)
Time frame: Week 0, week 26
Change in free fatty acid (FFA)
Time frame: Week 0, week 26
Number of patients permanently discontinuing treatment with Victoza®
Time frame: Week 26
Reasons for permanent treatment discontinuations
Time frame: Week 26
Changes in quality of life (EQ-5D index score)
Time frame: Week 0, week 26
Changes in quality of life (EQ VAS)
Time frame: Week 0, week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 16 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin A1c (HbA1c) (percentage) (time frame: Week 0, week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.