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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1185-3661 | Other Identifier | WHO | |
| EUPAS16225 | Registry Identifier | EU PAS Register |
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This study is conducted in Europe. The aim of this study is to investigate usage of liraglutide for weight management in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Patients will be treated according to routine clinical practice at the discretion of the treating physician. The study will gather data over the course of routine treatment for liraglutide 3.0 mg and liraglutide 1.2 mg/1.8 mg treated patients |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with BMI above or equal to 30 kg/m^2 | Less than 6 months before date of first prescription | |
| Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity | Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities | Less than 6 months before date of first prescription |
| Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities | Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities. | Less than 6 months before date of first prescription |
| Number of patients with BMI below 27 kg/m^2 | Less than 6 months before date of first prescription | |
| Number of patients with BMI not measured | Within 6 months before date of the first prescription |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day | From date of first prescription until 24 months | |
| Number of patients with liraglutide 1.2 or 1.8 mg prescriptions and indication of weight management |
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Inclusion Criteria:
Exclusion Criteria:
-Patients or physicians who previously participated in interventional studies for liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg will not be eligible to participate in the study -For the full study, sites and patients included in the pilot will be excluded
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This is a descriptive study designed to examine in-market utilisation of liraglutide; thus there will be no hypothesis testing and a power calculation is not applicable. 100 patients will be enrolled for the pilot study (50 in each country, ) and additionally 300 patients will be enrolled for the full study (150 in each country)
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR,1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Bad Nauheim | 61231 | Germany | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36514273 | Result | Sbraccia P, Aberle J, Olsen AH, Rathor N, Major-Pedersen A. Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study. Diabetes Obes Metab. 2023 Apr;25(4):985-991. doi: 10.1111/dom.14945. Epub 2023 Jan 23. |
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| From date of first prescription until 24 months |
| Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg | While adhering to the dose escalation according to label | By 12 weeks after first prescription date |
| Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg | Number of patients | From date of first prescription until 24 months |
| Number of patients with continued treatment with liraglutide 3.0 mg | Number of patients | From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months |
| Bünde |
| 32257 |
| Germany |
| Novo Nordisk Investigational Site | Essen | 45147 | Germany |
| Novo Nordisk Investigational Site | Hamburg | 20097 | Germany |
| Novo Nordisk Investigational Site | Kaiserslautern | 67655 | Germany |
| Novo Nordisk Investigational Site | Mainz | 55124 | Germany |
| Novo Nordisk Investigational Site | München | 81477 | Germany |
| Novo Nordisk Investigational Site | Münster | 48143 | Germany |
| Novo Nordisk Investigational Site | Ulm | 89073 | Germany |
| Novo Nordisk Investigational Site | Catania | 95122 | Italy |
| Novo Nordisk Investigational Site | Chieti | 66100 | Italy |
| Novo Nordisk Investigational Site | Cremona | 26900 | Italy |
| Novo Nordisk Investigational Site | Novara | 28100 | Italy |
| Novo Nordisk Investigational Site | Pisa | 56126 | Italy |
| Novo Nordisk Investigational Site | Potenza | 85100 | Italy |
| Novo Nordisk Investigational Site | Roma | 00128 | Italy |
| Novo Nordisk Investigational Site | Rome | 00168 | Italy |
| Novo Nordisk Investigational Site | Rome | 161 | Italy |
| Novo Nordisk Investigational Site | Siena | 53100 | Italy |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |