Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT ID: NCT00518882
Last Updated: 2017-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
467 participants
INTERVENTIONAL
2007-08-31
2009-04-30
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
NONE
Study Groups
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Liraglutide
Liraglutide 1.8 mg once daily + subject's own OAD treatment
liraglutide
1.8 mg once daily for s.c. (under the skin) injection.
Exenatide
Exenatide 10 mcg twice daily + subject's own OAD treatment
exenatide
10 mcg twice daily for s.c. (under the skin) injection.
Interventions
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liraglutide
1.8 mg once daily for s.c. (under the skin) injection.
exenatide
10 mcg twice daily for s.c. (under the skin) injection.
Eligibility Criteria
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Inclusion Criteria
* Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator
* HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%
* Body Mass Index (BMI) equal to or lower than 45.0 kg/m2
Exclusion Criteria
* Treatment with any anti-diabetic drug other than metformin and sulphonylurea
* Any previous exposure to exenatide or liraglutide
* Impaired liver or/and renal function
* History of any significant cardiac events
* Known retinopathy or maculopathy requiring acute treatment
* Recurrent major hypoglycaemia or hypoglycaemic unawareness
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
Birmingham, Alabama, United States
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Goodyear, Arizona, United States
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Artesia, California, United States
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Encino, California, United States
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Escondido, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Mateo, California, United States
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Spring Valley, California, United States
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Walnut Creek, California, United States
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Fort Myers, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Longwood, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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Saint Cloud, Florida, United States
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Atlanta, Georgia, United States
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Powder Springs, Georgia, United States
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Roswell, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Evansville, Indiana, United States
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Des Moines, Iowa, United States
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New Orleans, Louisiana, United States
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Minneapolis, Minnesota, United States
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Saint Paul, Minnesota, United States
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City of Saint Peters, Missouri, United States
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Flemington, New Jersey, United States
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South Bound Brook, New Jersey, United States
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Northport, New York, United States
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Chapel Hill, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Kettering, Ohio, United States
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Mentor, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sumter, South Carolina, United States
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Chattanooga, Tennessee, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Graz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Aalborg, , Denmark
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Århus C, , Denmark
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Gentofte Municipality, , Denmark
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Hvidovre, , Denmark
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Odense, , Denmark
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Helsinki, , Finland
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Lahti, , Finland
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Oulu, , Finland
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Antibes, , France
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Dommartin-lès-Toul, , France
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La Rochelle, , France
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Narbonne, , France
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Nevers, , France
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Bochum, , Germany
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Dreieich-Sprendlingen, , Germany
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Falkensee, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Herrenberg, , Germany
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Lampertheim, , Germany
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Ludwigshafen, , Germany
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Marburg, , Germany
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Pohlheim, , Germany
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Rehlingen-Siersburg, , Germany
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Speyer, , Germany
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Tübingen, , Germany
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Skopje, , North Macedonia
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Bergen, , Norway
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Bergen, , Norway
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Stavanger, , Norway
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Trondheim, , Norway
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Bydgoszcz, , Poland
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Gniewkowo, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Tychy, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Manatí, , Puerto Rico
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Alba Iulia, Alba, Romania
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Suceava, Suceava, Romania
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Reşiţa, , Romania
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Koper, , Slovenia
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Ljubljana, , Slovenia
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Novo Mesto, , Slovenia
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L'Hospitalet de Llobregat, , Spain
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Oviedo, , Spain
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Palma de Mallorca, , Spain
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Puerto del Rosario, , Spain
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Stockholm, , Sweden
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Stockholm, , Sweden
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Basel, , Switzerland
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Bern, , Switzerland
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Geneva, , Switzerland
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Lugano, , Switzerland
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.
Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39-47. doi: 10.1016/S0140-6736(09)60659-0. Epub 2009 Jun 8.
Buse JB, Sesti G, Schmidt WE, Montanya E, Chang CT, Xu Y, Blonde L, Rosenstock J; Liraglutide Effect Action in Diabetes-6 Study Group. Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care. 2010 Jun;33(6):1300-3. doi: 10.2337/dc09-2260. Epub 2010 Mar 23.
Schmidt WE, Christiansen JS, Hammer M, Zychma MJ, Buse JB. Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study. Diabet Med. 2011 Jun;28(6):715-23. doi: 10.1111/j.1464-5491.2011.03276.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.
Valentine WJ, Palmer AJ, Lammert M, Langer J, Brandle M. Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents. Clin Ther. 2011 Nov;33(11):1698-712. doi: 10.1016/j.clinthera.2011.09.022. Epub 2011 Oct 21.
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.
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.
Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.
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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2006-006092-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN2211-1797
Identifier Type: -
Identifier Source: org_study_id
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