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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-2199 | Other Identifier | WHO |
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The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1% | month 12 | |
| Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1% | month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | month 12 | |
| Fasting blood glucose (FBG) | month 12 | |
| Incidence of serious adverse events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with type 2 diabetes mellitus for whom physicians determine that liraglutide is an appropriate new treatment.
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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 | Brussels | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26004030 | Result | Buysschaert M, D'Hooge D, Preumont V; Roots Study Group. ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza(R)) in type 2 diabetic patients. Diabetes Metab Syndr. 2015 Jul-Sep;9(3):139-42. doi: 10.1016/j.dsx.2015.05.001. Epub 2015 May 8. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| 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 |
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| months 0-12 |
| Incidence of adverse drug reactions (ADRs) | months 0-12 |
| Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar) | months 0-12 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |