Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT ID: NCT00318422
Last Updated: 2017-01-25
Study Results
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Basic Information
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COMPLETED
PHASE3
1041 participants
INTERVENTIONAL
2006-05-31
2007-05-31
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
rosiglitazone
glimepiride
Eligibility Criteria
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Inclusion Criteria
* Treatment with oral anti-diabetic drugs for at least 3 months
* HbA1c: 7.0-11.0 % (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 45.0 kg/m2.
Exclusion Criteria
* Treatment with any drug that could interfere with the glucose level
* Any serious medical condition
* Females who are pregnant, have the 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
Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Mendoza, , Argentina
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Woolloongabba, Queensland, Australia
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Melbourne, Victoria, Australia
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Caboolture, , Australia
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Ingleburn, , Australia
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Kippa-Ring, , Australia
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Miranda, , Australia
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Randwick, , Australia
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Southport, , Australia
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Stones Corner, , Australia
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Fortaleza, , Brazil
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São Paulo, , Brazil
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Osijek, , Croatia
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Slavonski Brod, , Croatia
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Split, , Croatia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Ostrava, , Czechia
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Plzen - Lochotin, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Espoo, , Finland
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Helsinki, , Finland
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Lahti, , Finland
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Nurmijärvi, , Finland
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Oulu, , Finland
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Pieksämäki, , Finland
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Rauma, , Finland
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Rovaniemi, , Finland
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Tampere, , Finland
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Tampere, , Finland
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Dax, , France
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La Rochelle, , France
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Montpellier, , France
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Mougins, , France
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Narbonne, , France
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Nevers, , France
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Paris, , France
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Rennes, , France
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Saint-Mandé, , France
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Mumbai, Maharashtra, India
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Chandigarh, Punjab, India
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Chennai, , India
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Mumbai, , India
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Haifa, , Israel
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Jerusalem, , Israel
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Tel Litwinsky, , Israel
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Catania, , Italy
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Lucca, , Italy
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Milan, , Italy
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Napoli, , Italy
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Perugia, , Italy
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Ravenna, , Italy
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Roma, , Italy
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Torino, , Italy
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Cheras, , Malaysia
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Kota Bharu, Kelantan, , Malaysia
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Pulau Pinang, , Malaysia
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Davao City, , Philippines
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Makati City, , Philippines
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Marikina City, , Philippines
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Quezon City, , Philippines
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Bytom, , Poland
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Gdansk, , Poland
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Gniewkowo, , Poland
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Kamieniec Ząbkowicki, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Mazowieckie, , Poland
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Nysa, , Poland
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Rawa Mazowiecka, , Poland
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Szczecin, , Poland
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Tychy, , Poland
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Warsaw, , Poland
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Zabrze, , Poland
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Brasov, Brașov County, Romania
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Ploieşti, Prahova, Romania
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Baia Mare, , Romania
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Bucharest, , Romania
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Timișoara, , Romania
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Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa
Novo Nordisk Investigational Site
Umhlanga, , South Africa
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Gijón, , Spain
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Palma de Mallorca, , Spain
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Reus, , Spain
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Bern, , Switzerland
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Lausanne, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
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Zurich, , Switzerland
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Izmir, , Turkey (Türkiye)
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.
Marre M, Shaw J, Brandle M, Bebakar WM, Kamaruddin NA, Strand J, Zdravkovic M, Le Thi TD, Colagiuri S; LEAD-1 SU study group. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet Med. 2009 Mar;26(3):268-78. doi: 10.1111/j.1464-5491.2009.02666.x.
Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997.
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.
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.
Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.
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.
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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2005-003414-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN2211-1436
Identifier Type: -
Identifier Source: org_study_id
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