Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT ID: NCT00331851
Last Updated: 2017-01-26
Study Results
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Basic Information
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COMPLETED
PHASE3
584 participants
INTERVENTIONAL
2006-05-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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liraglutide
insulin glargine
metformin
glimepiride
Eligibility Criteria
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Inclusion Criteria
* Treatment with oral anti-diabetic drugs for at least 3 months
* HbA1c: 7.5-10.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy.
* Body Mass Index (BMI) less than or equal to 45 kg/m2
Exclusion Criteria
* Treatment with any drug that could interfere with the glucose level
* Any serious medical condition
* Females who are pregnant, have intention of becoming pregnant or are breastfeeding
18 Years
80 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Bahía Blanca, , Argentina
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Ciudad Autonoma de Bs As, , Argentina
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Junín, , Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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Bregenz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Curitiba, , Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Århus C, , Denmark
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Esbjerg, , Denmark
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Gentofte Municipality, , Denmark
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Hellerup, , Denmark
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Hillerød, , Denmark
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Roskilde, , Denmark
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Slagelse, , Denmark
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Helsinki, , Finland
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Helsinki, , Finland
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Kuopio, , Finland
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Oulu, , Finland
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Turku, , Finland
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Besançon, , France
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Brest, , France
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Corbeil-Essonnes, , France
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Dijon, , France
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La Rochelle, , France
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Nanterre, , France
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Narbonne, , France
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Nevers, , France
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Vénissieux, , France
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Hyderabad, Andhra Pradesh, India
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Karnāl, Haryana, India
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Pune, Maharashtra, India
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Hyderabad, , India
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Patna, , India
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Bergamo, , Italy
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Bologna, , Italy
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Catania, , Italy
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Catanzaro, , Italy
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Chieri, , Italy
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Chieti Scalo, , Italy
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Messina, , Italy
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Padua, , Italy
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Parma, , Italy
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Siena, , Italy
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Almere Stad, , Netherlands
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Den Helder, , Netherlands
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Eindhoven, , Netherlands
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Gouda, , Netherlands
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Maastricht, , Netherlands
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The Hague, , Netherlands
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Zevenaar, , Netherlands
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Zoetermeer, , Netherlands
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Bergen, , Norway
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Gjettum, , Norway
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Jessheim, , Norway
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Nordbyhagen, , Norway
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Notodden, , Norway
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Sandvika, , Norway
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Skedsmokorset, , Norway
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Cebu City, , Philippines
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Manila, , Philippines
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Marikina City, , Philippines
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Pasig, , Philippines
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Gdynia, , Poland
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Katowice, , Poland
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Opole, , Poland
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Poznan, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Belgrade, , Serbia and Montenegro
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Nis, , Serbia and Montenegro
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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L'ubochna, , Slovakia
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Martin, , Slovakia
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Nitra, , Slovakia
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Žilina, , Slovakia
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Bloemfontein, Free State, South Africa
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Pretoria, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Worcester, Western Cape, South Africa
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Barakaldo, , Spain
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Barcelona, , Spain
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Getafe, , Spain
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Málaga, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Ayr, , United Kingdom
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Bradford, , United Kingdom
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Guildford, , United Kingdom
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Liverpool, , United Kingdom
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Livingstone, , United Kingdom
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Llantrisant, , United Kingdom
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Manchester, , United Kingdom
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Nottingham, , United Kingdom
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Salford, , United Kingdom
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Sheffield, , United Kingdom
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Swansea, , United Kingdom
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Watford, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN2211-1697
Identifier Type: -
Identifier Source: org_study_id
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