Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT ID: NCT00333151
Last Updated: 2017-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
576 participants
INTERVENTIONAL
2006-05-31
2007-08-31
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
metformin
Eligibility Criteria
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Inclusion Criteria
* Treated with oral anti-diabetic (OAD) drugs for at least 3 months
* Treated with one or more OAD and in moderate to poor glycemic control
* Body Mass Index (BMI) less than or equal to 45.0 kg/m2
Exclusion Criteria
* Any serious medical condition
* Treatment with any drug that could interfere with glucose level
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
Goodyear, Arizona, United States
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Colton, California, United States
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Concord, California, United States
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Escondido, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Orange, California, United States
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Santa Ana, California, United States
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Santa Barbara, California, United States
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Spring Valley, California, United States
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New Britain, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Lake Mary, Florida, United States
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Plantation, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Powder Springs, Georgia, United States
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Idaho Falls, Idaho, United States
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Peoria, Illinois, United States
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New Albany, Indiana, United States
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Des Moines, Iowa, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
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Hyattsville, Maryland, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Reno, Nevada, United States
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Berlin, New Jersey, United States
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Plainsboro, New Jersey, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Northport, New York, United States
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Rochester, New York, United States
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Asheville, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, 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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Duncan, South Carolina, United States
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Chattanooga, Tennessee, United States
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Arlington, 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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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Gatineau, , Canada
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Mississauga, , Canada
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Montreal, , Canada
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Montreal, , Canada
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Québec, , Canada
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Red Deer, , Canada
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St. John's, , Canada
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Toronto, , Canada
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Vancouver, , Canada
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Windsor, , Canada
Countries
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References
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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.
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.
Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, Hale PM, Zdravkovic M, Blonde L; LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009 Jul;32(7):1224-30. doi: 10.2337/dc08-2124. Epub 2009 Mar 16.
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.
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.
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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN2211-1574
Identifier Type: -
Identifier Source: org_study_id
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