Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGLiraglutide
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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin A1c (HbA1c) (percentage) | Week 0, week 26 | Measured in percentage. |
| Change in HbA1c (mmol/mol) | Week 0, week 26 | Measured in mmol/mol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | Week 0, week 26 | Measured in centimetres. |
| Change in fasting blood glucose (FBG) (self-measured) | Week 0, week 26 | Measured in mg/dL. |
| Change in total cholesterol (TC) | Week 0, week 26 | Measured in mg/dL. |
| Change in low density lipoprotein cholesterol (LDL-C) | Week 0, week 26 | Measured in mg/dL. |
| Change in high density lipoprotein cholesterol (HDL-C) | Week 0, week 26 | Measured in mg/dL. |
| Change in body weight (kilogram) | Week 0, week 26 | Measured in kilogram. |
| Change in free fatty acid (FFA) | Week 0, week 26 | Measured in mg/dL. |
| Number of patients permanently discontinuing treatment with Victoza® | Week 26 | Number of patients. |
| Reasons for permanent treatment discontinuations | Week 26 | Number of occurrence of pre-specified events. |
| Changes in quality of life (EQ-5D index score) | 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) | 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. |
| Change in triglyceride (TG) | Week 0, week 26 | Measured in mg/dL. |
| Change in body weight (percentage) | Week 0, week 26 | Measured in percentage. |
Countries
Iran
Outcome results
None listed