Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
LEAD-4
Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes
1 other identifier
interventional
576
2 countries
89
Brief Summary
This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes
Started May 2006
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 1, 2006
CompletedFirst Posted
Study publicly available on registry
June 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJanuary 25, 2017
January 1, 2017
1.3 years
June 1, 2006
January 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
after 26 weeks of treatment
Secondary Outcomes (3)
body weight
Safety and tolerability
Glycaemic control
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- 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
You may not qualify if:
- Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator
- Any serious medical condition
- Treatment with any drug that could interfere with glucose level
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (89)
Novo Nordisk Investigational Site
Goodyear, Arizona, 85395, United States
Novo Nordisk Investigational Site
Colton, California, 92324, United States
Novo Nordisk Investigational Site
Concord, California, 94520, United States
Novo Nordisk Investigational Site
Escondido, California, 92025, United States
Novo Nordisk Investigational Site
La Jolla, California, 92037, United States
Novo Nordisk Investigational Site
Long Beach, California, 90822, United States
Novo Nordisk Investigational Site
Los Angeles, California, 90024, United States
Novo Nordisk Investigational Site
Los Angeles, California, 90057, United States
Novo Nordisk Investigational Site
Mission Viejo, California, 92691, United States
Novo Nordisk Investigational Site
Orange, California, 92869, United States
Novo Nordisk Investigational Site
Santa Ana, California, 92705, United States
Novo Nordisk Investigational Site
Santa Barbara, California, 93105, United States
Novo Nordisk Investigational Site
Spring Valley, California, 91978, United States
Novo Nordisk Investigational Site
New Britain, Connecticut, 06050, United States
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, 20010, United States
Novo Nordisk Investigational Site
Fort Myers, Florida, 33907, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204, United States
Novo Nordisk Investigational Site
Lake Mary, Florida, 32746, United States
Novo Nordisk Investigational Site
Plantation, Florida, 33324, United States
Novo Nordisk Investigational Site
Athens, Georgia, 30606, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, 30032, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, 30034, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318, United States
Novo Nordisk Investigational Site
Powder Springs, Georgia, 30127, United States
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596, United States
Novo Nordisk Investigational Site
Peoria, Illinois, 61615, United States
Novo Nordisk Investigational Site
New Albany, Indiana, 47150, United States
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314, United States
Novo Nordisk Investigational Site
Topeka, Kansas, 66606, United States
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503, United States
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, 70808, United States
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70121, United States
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782, United States
Novo Nordisk Investigational Site
Tupelo, Mississippi, 38801, United States
Novo Nordisk Investigational Site
St Louis, Missouri, 63110, United States
Novo Nordisk Investigational Site
Reno, Nevada, 89502, United States
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009, United States
Novo Nordisk Investigational Site
Plainsboro, New Jersey, 08536, United States
Novo Nordisk Investigational Site
Albany, New York, 12206, United States
Novo Nordisk Investigational Site
Brooklyn, New York, 11203, United States
Novo Nordisk Investigational Site
Northport, New York, 11768, United States
Novo Nordisk Investigational Site
Rochester, New York, 14621, United States
Novo Nordisk Investigational Site
Asheville, North Carolina, 28803, United States
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599-7172, United States
Novo Nordisk Investigational Site
Durham, North Carolina, 27710, United States
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245, United States
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195, United States
Novo Nordisk Investigational Site
Columbus, Ohio, 43203, United States
Novo Nordisk Investigational Site
Columbus, Ohio, 43212, United States
Novo Nordisk Investigational Site
Dayton, Ohio, 45406, United States
Novo Nordisk Investigational Site
Kettering, Ohio, 45429, United States
Novo Nordisk Investigational Site
Mentor, Ohio, 44060, United States
Novo Nordisk Investigational Site
Duncan, South Carolina, 29334, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404, United States
Novo Nordisk Investigational Site
Arlington, Texas, 76014, United States
Novo Nordisk Investigational Site
Dallas, Texas, 75230, United States
Novo Nordisk Investigational Site
Dallas, Texas, 75231, United States
Novo Nordisk Investigational Site
Dallas, Texas, 75246, United States
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8858, United States
Novo Nordisk Investigational Site
Houston, Texas, 77025, United States
Novo Nordisk Investigational Site
Houston, Texas, 77030, United States
Novo Nordisk Investigational Site
Lubbock, Texas, 79430-8183, United States
Novo Nordisk Investigational Site
Midland, Texas, 79707, United States
Novo Nordisk Investigational Site
San Antonio, Texas, 78209, United States
Novo Nordisk Investigational Site
San Antonio, Texas, 78229, United States
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84102, United States
Novo Nordisk Investigational Site
Newport News, Virginia, 23606, United States
Novo Nordisk Investigational Site
Richmond, Virginia, 23294, United States
Novo Nordisk Investigational Site
Spokane, Washington, 99218, United States
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209, United States
Novo Nordisk Investigational Site
Calgary, Alberta, T2H 2G4, Canada
Novo Nordisk Investigational Site
Edmonton, Alberta, T5J 3N4, Canada
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R3E 3P4, Canada
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3H 1V7, Canada
Novo Nordisk Investigational Site
London, Ontario, N6A 4V2, Canada
Novo Nordisk Investigational Site
Ottawa, Ontario, K1N 6N5, Canada
Novo Nordisk Investigational Site
Toronto, Ontario, M5C 2T2, Canada
Novo Nordisk Investigational Site
Laval, Quebec, H7T 2P5, Canada
Novo Nordisk Investigational Site
Gatineau, J8T 8M1, Canada
Novo Nordisk Investigational Site
Mississauga, L5M 2V8, Canada
Novo Nordisk Investigational Site
Montreal, H2W 1R7, Canada
Novo Nordisk Investigational Site
Montreal, H3A 1A1, Canada
Novo Nordisk Investigational Site
Québec, G1V 4G2, Canada
Novo Nordisk Investigational Site
Red Deer, T4N 6V7, Canada
Novo Nordisk Investigational Site
St. John's, A1B 3V6, Canada
Novo Nordisk Investigational Site
Toronto, M5G 1X5, Canada
Novo Nordisk Investigational Site
Vancouver, V5Z 1C6, Canada
Novo Nordisk Investigational Site
Windsor, N8W 3K2, Canada
Related Publications (15)
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.
PMID: 21450987BACKGROUNDSullivan 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.
PMID: 19245711RESULTZinman 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.
PMID: 19289857RESULTMcGill 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.
PMID: 19491536RESULTBlonde 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.
PMID: 19878259RESULTBode 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.
PMID: 22055210RESULTHenry 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.
PMID: 22193143RESULTZinman 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.
PMID: 21883806RESULTNiswender 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.
PMID: 22862847RESULTAlves 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.
PMID: 23010561RESULTKing 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.
PMID: 23186975RESULTJensen 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.
PMID: 25504028RESULTDavidson 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.
PMID: 26936426RESULTFonseca 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.
PMID: 24561125DERIVEDHegedus 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.
PMID: 21209033DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2006
First Posted
June 2, 2006
Study Start
May 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
January 25, 2017
Record last verified: 2017-01