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This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | after 14 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight after 14 weeks. | ||
| Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks. | ||
| Safety and tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Aalborg | 9000 | Denmark | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18201212 | Result | Vilsboll T, Brock B, Perrild H, Levin K, Lervang HH, Kolendorf K, Krarup T, Schmitz O, Zdravkovic M, Le-Thi T, Madsbad S. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus. Diabet Med. 2008 Feb;25(2):152-6. doi: 10.1111/j.1464-5491.2007.02333.x. Epub 2008 Jan 14. | |
| 19183322 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Århus C |
| 8000 |
| Denmark |
| Novo Nordisk Investigational Site | Copenhagen | 2400 | Denmark |
| Novo Nordisk Investigational Site | Hellerup | 2900 | Denmark |
| Novo Nordisk Investigational Site | Hvidovre | 2650 | Denmark |
| Novo Nordisk Investigational Site | Kolding | 6000 | Denmark |
| Novo Nordisk Investigational Site | København S | 2300 | Denmark |
| Novo Nordisk Investigational Site | Køge | 4600 | Denmark |
| Novo Nordisk Investigational Site | Antibes | 06600 | France |
| Novo Nordisk Investigational Site | Dax | 40107 | France |
| Novo Nordisk Investigational Site | La Rochelle | 17019 | France |
| Novo Nordisk Investigational Site | Marseille | 13009 | France |
| Novo Nordisk Investigational Site | Montpellier | 34295 | France |
| Novo Nordisk Investigational Site | Mougins | 06250 | France |
| Novo Nordisk Investigational Site | Narbonne | 11108 | France |
| Novo Nordisk Investigational Site | Nevers | 58033 | France |
| Novo Nordisk Investigational Site | Nîmes | 30006 | France |
| Novo Nordisk Investigational Site | Pessac | 33600 | France |
| Novo Nordisk Investigational Site | Rennes | 35056 | France |
| Novo Nordisk Investigational Site | Vénissieux | 69200 | France |
| Novo Nordisk Investigational Site | 's-Hertogenbosch | 5223 GV | Netherlands |
| Novo Nordisk Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| Novo Nordisk Investigational Site | Apeldoorn | 7334 DZ | Netherlands |
| Novo Nordisk Investigational Site | Groningen | 9713 GZ | Netherlands |
| Novo Nordisk Investigational Site | Hengelo | 7555 DL | Netherlands |
| Novo Nordisk Investigational Site | Sliedrecht | 3361 XV | Netherlands |
| Novo Nordisk Investigational Site | The Hague | 2512 VA | Netherlands |
| Novo Nordisk Investigational Site | Banská Bystrica | 95717 | Slovakia |
| Novo Nordisk Investigational Site | Bratislava | 811 08 | Slovakia |
| Novo Nordisk Investigational Site | Bratislava | 81526 | Slovakia |
| Novo Nordisk Investigational Site | Bratislava | 82102 | Slovakia |
| Novo Nordisk Investigational Site | Bratislava | 831 01 | Slovakia |
| Novo Nordisk Investigational Site | Košice | 040 01 | Slovakia |
| Novo Nordisk Investigational Site | Košice | 04011 | Slovakia |
| Novo Nordisk Investigational Site | Košice | 04190 | Slovakia |
| Novo Nordisk Investigational Site | Lučenec | 98401 | Slovakia |
| Novo Nordisk Investigational Site | Prešov | 080 01 | Slovakia |
| Novo Nordisk Investigational Site | Šahy | 93601 | Slovakia |
| Novo Nordisk Investigational Site | Žilina | 01001 | Slovakia |
| Result |
| Courreges JP, Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Verhoeven R, Buganova I, Madsbad S. Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes. Diabet Med. 2008 Sep;25(9):1129-31. doi: 10.1111/j.1464-5491.2008.02484.x. No abstract available. |
| 17372153 | Result | Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courreges JP, Verhoeven R, Buganova I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007 Jun;30(6):1608-10. doi: 10.2337/dc06-2593. Epub 2007 Mar 19. No abstract available. |
| 18435773 | Result | Horowitz M, Vilsboll T, Zdravkovic M, Hammer M, Madsbad S. Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide. Diabetes Obes Metab. 2008 Jul;10(7):593-6. doi: 10.1111/j.1463-1326.2008.00861.x. Epub 2008 Apr 22. No abstract available. |
| 25504028 | Result | Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. |
| 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 |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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