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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1213-4238 | Other Identifier | World Health Organization (WHO) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Patients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin A1c (HbA1c) (percentage) | Measured in percentage. | Week 0, week 26 |
| Change in HbA1c (mmol/mol) | Measured in mmol/mol. | Week 0, week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight (kilogram) | Measured in kilogram. | Week 0, week 26 |
| Change in body weight (percentage) | Measured in percentage. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with T2DM in Iran judged by the study doctor for whom Victoza® is indicated are eligible to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Ahvāz | Iran | ||||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
|
| Week 0, week 26 |
| Change in waist circumference | Measured in centimetres. | Week 0, week 26 |
| Change in fasting blood glucose (FBG) (self-measured) | Measured in mg/dL. | Week 0, week 26 |
| Change in total cholesterol (TC) | Measured in mg/dL. | Week 0, week 26 |
| Change in low density lipoprotein cholesterol (LDL-C) | Measured in mg/dL. | Week 0, week 26 |
| Change in high density lipoprotein cholesterol (HDL-C) | Measured in mg/dL. | Week 0, week 26 |
| Change in triglyceride (TG) | Measured in mg/dL. | Week 0, week 26 |
| Change in free fatty acid (FFA) | Measured in mg/dL. | Week 0, week 26 |
| Number of patients permanently discontinuing treatment with Victoza® | Number of patients. | Week 26 |
| Reasons for permanent treatment discontinuations | Number of occurrence of pre-specified events. | 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. | 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. | Week 0, week 26 |
| Ardabil |
| Iran |
| Novo Nordisk Investigational Site | Babol | Iran |
| Novo Nordisk Investigational Site | Gorgan | Iran |
| Novo Nordisk Investigational Site | Hamadan | Iran |
| Novo Nordisk Investigational Site | Hormozgan | Iran |
| Novo Nordisk Investigational Site | Isfahan | Iran |
| Novo Nordisk Investigational Site | Islamshahr | Iran |
| Novo Nordisk Investigational Site | Karaj | Iran |
| Novo Nordisk Investigational Site | Kerman | Iran |
| Novo Nordisk Investigational Site | Mashahd | Iran |
| Novo Nordisk Investigational Site | Mashhad | Iran |
| Novo Nordisk Investigational Site | Sari | Iran |
| Novo Nordisk Investigational Site | Shiraz | Iran |
| Novo Nordisk Investigational Site | Tehran | Iran |
| Novo Nordisk Investigational Site | Yazd | Iran |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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