Diabetes Mellitus, Type 2 Clinical Trial
— LEAD-4Official title:
Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 576 |
| Est. completion date | August 2007 |
| Est. primary completion date | August 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Novo Nordisk Investigational Site | Calgary | Alberta |
| Canada | Novo Nordisk Investigational Site | Edmonton | Alberta |
| Canada | Novo Nordisk Investigational Site | Gatineau | |
| Canada | Novo Nordisk Investigational Site | Halifax | Nova Scotia |
| Canada | Novo Nordisk Investigational Site | Laval | Quebec |
| Canada | Novo Nordisk Investigational Site | London | Ontario |
| Canada | Novo Nordisk Investigational Site | Mississauga | |
| Canada | Novo Nordisk Investigational Site | Montreal | |
| Canada | Novo Nordisk Investigational Site | Montreal | |
| Canada | Novo Nordisk Investigational Site | Ottawa | Ontario |
| Canada | Novo Nordisk Investigational Site | Quebec | |
| Canada | Novo Nordisk Investigational Site | Red Deer | |
| Canada | Novo Nordisk Investigational Site | St John's | |
| Canada | Novo Nordisk Investigational Site | Toronto | |
| Canada | Novo Nordisk Investigational Site | Toronto | Ontario |
| Canada | Novo Nordisk Investigational Site | Vancouver | |
| Canada | Novo Nordisk Investigational Site | Windsor | |
| Canada | Novo Nordisk Investigational Site | Winnipeg | Manitoba |
| United States | Novo Nordisk Investigational Site | Albany | New York |
| United States | Novo Nordisk Investigational Site | Arlington | Texas |
| United States | Novo Nordisk Investigational Site | Asheville | North Carolina |
| United States | Novo Nordisk Investigational Site | Athens | Georgia |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Baton Rouge | Louisiana |
| United States | Novo Nordisk Investigational Site | Berlin | New Jersey |
| United States | Novo Nordisk Investigational Site | Brooklyn | New York |
| United States | Novo Nordisk Investigational Site | Chapel Hill | North Carolina |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Colton | California |
| United States | Novo Nordisk Investigational Site | Columbus | Ohio |
| United States | Novo Nordisk Investigational Site | Columbus | Ohio |
| United States | Novo Nordisk Investigational Site | Concord | California |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dayton | Ohio |
| United States | Novo Nordisk Investigational Site | Des Moines | Iowa |
| United States | Novo Nordisk Investigational Site | Duncan | South Carolina |
| United States | Novo Nordisk Investigational Site | Durham | North Carolina |
| United States | Novo Nordisk Investigational Site | Escondido | California |
| United States | Novo Nordisk Investigational Site | Fort Myers | Florida |
| United States | Novo Nordisk Investigational Site | Goodyear | Arizona |
| United States | Novo Nordisk Investigational Site | Greenville | North Carolina |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Hyattsville | Maryland |
| United States | Novo Nordisk Investigational Site | Idaho Falls | Idaho |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Kettering | Ohio |
| United States | Novo Nordisk Investigational Site | La Jolla | California |
| United States | Novo Nordisk Investigational Site | Lake Mary | Florida |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Long Beach | California |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Lubbock | Texas |
| United States | Novo Nordisk Investigational Site | Mentor | Ohio |
| United States | Novo Nordisk Investigational Site | Midland | Texas |
| United States | Novo Nordisk Investigational Site | Milwaukee | Wisconsin |
| United States | Novo Nordisk Investigational Site | Mission Viejo | California |
| United States | Novo Nordisk Investigational Site | New Albany | Indiana |
| United States | Novo Nordisk Investigational Site | New Britain | Connecticut |
| United States | Novo Nordisk Investigational Site | New Orleans | Louisiana |
| United States | Novo Nordisk Investigational Site | Newport News | Virginia |
| United States | Novo Nordisk Investigational Site | Northport | New York |
| United States | Novo Nordisk Investigational Site | Orange | California |
| United States | Novo Nordisk Investigational Site | Peoria | Illinois |
| United States | Novo Nordisk Investigational Site | Plainsboro | New Jersey |
| United States | Novo Nordisk Investigational Site | Plantation | Florida |
| United States | Novo Nordisk Investigational Site | Powder Springs | Georgia |
| United States | Novo Nordisk Investigational Site | Reno | Nevada |
| United States | Novo Nordisk Investigational Site | Richmond | Virginia |
| United States | Novo Nordisk Investigational Site | Rochester | New York |
| United States | Novo Nordisk Investigational Site | Salt Lake City | Utah |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | Santa Ana | California |
| United States | Novo Nordisk Investigational Site | Santa Barbara | California |
| United States | Novo Nordisk Investigational Site | Spokane | Washington |
| United States | Novo Nordisk Investigational Site | Spring Valley | California |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Tupelo | Mississippi |
| United States | Novo Nordisk Investigational Site | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Canada,
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. — View Citation
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 — View Citation
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 Geriat — View Citation
Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk 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. — View Citation
Davidson JA, Ørsted 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 Ju — View Citation
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. — View Citation
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- — View Citation
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 Ja — View Citation
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. Review. — View Citation
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 Ja — View Citation
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. — View Citation
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 pa — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | after 26 weeks of treatment | ||
| Secondary | body weight | |||
| Secondary | Safety and tolerability | |||
| Secondary | Glycaemic control |
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