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This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | |||
| insulin glargine | Drug | |||
| metformin | Drug | |||
| glimepiride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | after 26 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | ||
| Safety and tolerability | ||
| Beta-cell function |
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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 | Bahía Blanca | 8000 | Argentina | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19245711 | Result | Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12. | |
| 19491536 | Result | McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Glycaemic control |
| Ciudad Autonoma de Bs As |
| C1405CWB |
| Argentina |
| Novo Nordisk Investigational Site | Junín | 6000 | Argentina |
| Novo Nordisk Investigational Site | Mendoza | 5500 | Argentina |
| Novo Nordisk Investigational Site | Rosario | 2000 | Argentina |
| Novo Nordisk Investigational Site | Bregenz | A - 6900 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1010 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1030 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1120 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1130 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1230 | Austria |
| Novo Nordisk Investigational Site | Vienna | A 1090 | Austria |
| Novo Nordisk Investigational Site | Curitiba | 80810-040 | Brazil |
| Novo Nordisk Investigational Site | Rio de Janeiro | 20211-340 | Brazil |
| Novo Nordisk Investigational Site | Rio de Janeiro | 21941-590 | Brazil |
| Novo Nordisk Investigational Site | São Paulo | 05403-000 | Brazil |
| Novo Nordisk Investigational Site | São Paulo | 11060-001 | Brazil |
| Novo Nordisk Investigational Site | São Paulo | 80540-010 | Brazil |
| Novo Nordisk Investigational Site | Århus C | 8000 | Denmark |
| Novo Nordisk Investigational Site | Esbjerg | 6700 | Denmark |
| Novo Nordisk Investigational Site | Gentofte Municipality | 2820 | Denmark |
| Novo Nordisk Investigational Site | Hellerup | 2900 | Denmark |
| Novo Nordisk Investigational Site | Hillerød | 3400 | Denmark |
| Novo Nordisk Investigational Site | Roskilde | 4000 | Denmark |
| Novo Nordisk Investigational Site | Slagelse | 4200 | Denmark |
| Novo Nordisk Investigational Site | Helsinki | 00250 | Finland |
| Novo Nordisk Investigational Site | Helsinki | 00260 | Finland |
| Novo Nordisk Investigational Site | Kuopio | 70210 | Finland |
| Novo Nordisk Investigational Site | Oulu | FI-90220 | Finland |
| Novo Nordisk Investigational Site | Turku | 20700 | Finland |
| Novo Nordisk Investigational Site | Besançon | 25030 | France |
| Novo Nordisk Investigational Site | Brest | 29200 | France |
| Novo Nordisk Investigational Site | Corbeil-Essonnes | 91106 | France |
| Novo Nordisk Investigational Site | Dijon | 21079 | France |
| Novo Nordisk Investigational Site | La Rochelle | 17019 | France |
| Novo Nordisk Investigational Site | Nanterre | 92014 | France |
| Novo Nordisk Investigational Site | Narbonne | 11108 | France |
| Novo Nordisk Investigational Site | Nevers | 58033 | France |
| Novo Nordisk Investigational Site | Vénissieux | 69200 | France |
| Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | 500034 | India |
| Novo Nordisk Investigational Site | Karnāl | Haryana | 132001 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411 037 | India |
| Novo Nordisk Investigational Site | Hyderabad | 600034 | India |
| Novo Nordisk Investigational Site | Patna | 800020 | India |
| Novo Nordisk Investigational Site | Bergamo | 24127 | Italy |
| Novo Nordisk Investigational Site | Bologna | 40133 | Italy |
| Novo Nordisk Investigational Site | Catania | 95124 | Italy |
| Novo Nordisk Investigational Site | Catanzaro | 88100 | Italy |
| Novo Nordisk Investigational Site | Chieri | 10023 | Italy |
| Novo Nordisk Investigational Site | Chieti Scalo | 66100 | Italy |
| Novo Nordisk Investigational Site | Messina | 98123 | Italy |
| Novo Nordisk Investigational Site | Padova | 35143 | Italy |
| Novo Nordisk Investigational Site | Parma | 43100 | Italy |
| Novo Nordisk Investigational Site | Siena | 53100 | Italy |
| Novo Nordisk Investigational Site | Almere Stad | 1311RL | Netherlands |
| Novo Nordisk Investigational Site | Den Helder | 1782 GZ | Netherlands |
| Novo Nordisk Investigational Site | Eindhoven | 5631 BM | Netherlands |
| Novo Nordisk Investigational Site | Gouda | 2803HH | Netherlands |
| Novo Nordisk Investigational Site | Maastricht | 6229 HX | Netherlands |
| Novo Nordisk Investigational Site | The Hague | 2512 VA | Netherlands |
| Novo Nordisk Investigational Site | Zevenaar | 6903 ZN | Netherlands |
| Novo Nordisk Investigational Site | Zoetermeer | 2725 NA | Netherlands |
| Novo Nordisk Investigational Site | Bergen | 5021 | Norway |
| Novo Nordisk Investigational Site | Gjettum | 1346 | Norway |
| Novo Nordisk Investigational Site | Jessheim | 2050 | Norway |
| Novo Nordisk Investigational Site | Nordbyhagen | 1474 | Norway |
| Novo Nordisk Investigational Site | Notodden | 3675 | Norway |
| Novo Nordisk Investigational Site | Sandvika | NO-1337 | Norway |
| Novo Nordisk Investigational Site | Skedsmokorset | NO-2020 | Norway |
| Novo Nordisk Investigational Site | Cebu City | 6000 | Philippines |
| Novo Nordisk Investigational Site | Manila | 1000 | Philippines |
| Novo Nordisk Investigational Site | Marikina City | 1810 | Philippines |
| Novo Nordisk Investigational Site | Pasig | 1605 | Philippines |
| Novo Nordisk Investigational Site | Gdynia | 81-366 | Poland |
| Novo Nordisk Investigational Site | Katowice | 40-053 | Poland |
| Novo Nordisk Investigational Site | Opole | 45-418 | Poland |
| Novo Nordisk Investigational Site | Poznan | 60-821 | Poland |
| Novo Nordisk Investigational Site | Wroclaw | 50-127 | Poland |
| Novo Nordisk Investigational Site | Zabrze | 41-800 | Poland |
| Novo Nordisk Investigational Site | Moscow | 117036 | Russia |
| Novo Nordisk Investigational Site | Moscow | 123448 | Russia |
| Novo Nordisk Investigational Site | Moscow | 127644 | Russia |
| Novo Nordisk Investigational Site | Belgrade | 11000 | Serbia and Montenegro |
| Novo Nordisk Investigational Site | Nis | 18000 | Serbia and Montenegro |
| Novo Nordisk Investigational Site | Banská Bystrica | 95717 | Slovakia |
| Novo Nordisk Investigational Site | Bratislava | 811 08 | Slovakia |
| Novo Nordisk Investigational Site | L'ubochna | 03491 | Slovakia |
| Novo Nordisk Investigational Site | Martin | 036 59 | Slovakia |
| Novo Nordisk Investigational Site | Nitra | 94 911 | Slovakia |
| Novo Nordisk Investigational Site | Žilina | 01001 | Slovakia |
| Novo Nordisk Investigational Site | Bloemfontein | Free State | 6850 | South Africa |
| Novo Nordisk Investigational Site | Pretoria | Gauteng | 0001 | South Africa |
| Novo Nordisk Investigational Site | Pretoria | Gauteng | 0181 | South Africa |
| Novo Nordisk Investigational Site | Worcester | Western Cape | 6850 | South Africa |
| Novo Nordisk Investigational Site | Barakaldo | 48903 | Spain |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Getafe | 28905 | Spain |
| Novo Nordisk Investigational Site | Málaga | 29009 | Spain |
| Novo Nordisk Investigational Site | Santiago de Compostela | 15706 | Spain |
| Novo Nordisk Investigational Site | Seville | 41014 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46014 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46015 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46026 | Spain |
| Novo Nordisk Investigational Site | Valladolid | 47011 | Spain |
| Novo Nordisk Investigational Site | Ayr | KA6 6DX | United Kingdom |
| Novo Nordisk Investigational Site | Bradford | BD9 6RJ | United Kingdom |
| Novo Nordisk Investigational Site | Guildford | GU2 7XX | United Kingdom |
| Novo Nordisk Investigational Site | Liverpool | L9 7AL | United Kingdom |
| Novo Nordisk Investigational Site | Livingstone | EH54 6PP | United Kingdom |
| Novo Nordisk Investigational Site | Llantrisant | CF72 8XR | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M41 5SL | United Kingdom |
| Novo Nordisk Investigational Site | Nottingham | NG7 2UH | United Kingdom |
| Novo Nordisk Investigational Site | Salford | M6 8HD | United Kingdom |
| Novo Nordisk Investigational Site | Sheffield | S5 7AU | United Kingdom |
| Novo Nordisk Investigational Site | Swansea | SA6 6NL | United Kingdom |
| Novo Nordisk Investigational Site | Watford | WD18 0HB | United Kingdom |
| 19688338 | Result | Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simo R; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2046-55. doi: 10.1007/s00125-009-1472-y. Epub 2009 Aug 14. |
| 19878259 | Result | Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x. |
| 21450987 | Result | Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30. |
| 22055210 | Result | Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4. |
| 22193143 | Result | Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906. |
| 21883806 | Result | Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30. |
| 22862847 | Result | Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9. |
| 23010561 | Result | Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23. |
| 23186975 | Result | King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR. |
| 25323312 | Result | Buse JB, Peters A, Russell-Jones D, Furber S, Donsmark M, Han J, MacConell L, Maggs D, Diamant M. Is insulin the most effective injectable antihyperglycaemic therapy? Diabetes Obes Metab. 2015 Feb;17(2):145-51. doi: 10.1111/dom.12402. Epub 2014 Nov 9. |
| 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. |
| 24561125 | Derived | Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21. |
| 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 |
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| C057619 | glimepiride |
| 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 |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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