Diabetes Mellitus, Type 2 Clinical Trial
— LEAD-5Official title:
Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.
| 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 Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.
| Status | Completed |
| Enrollment | 584 |
| Est. completion date | April 2007 |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes - Treatment with oral anti-diabetic drugs for at least 3 months - HbA1c: 7.5-10.0 % (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 kg/m2 Exclusion Criteria: - Treatment with insulin within the last 3 months - Treatment with any drug that could interfere with the glucose level - Any serious medical condition - Females who are pregnant, have intention of becoming pregnant or are breastfeeding |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novo Nordisk Investigational Site | Bahía Blanca | |
| Argentina | Novo Nordisk Investigational Site | Ciudad Autonoma de Bs As | |
| Argentina | Novo Nordisk Investigational Site | Junín | |
| Argentina | Novo Nordisk Investigational Site | Mendoza | |
| Argentina | Novo Nordisk Investigational Site | Rosario | |
| Austria | Novo Nordisk Investigational Site | Bregenz | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Brazil | Novo Nordisk Investigational Site | Curitiba | |
| Brazil | Novo Nordisk Investigational Site | Rio de Janeiro | |
| Brazil | Novo Nordisk Investigational Site | Rio de Janeiro | |
| Brazil | Novo Nordisk Investigational Site | San Paulo | |
| Brazil | Novo Nordisk Investigational Site | Sao Paulo | |
| Brazil | Novo Nordisk Investigational Site | São Paulo | |
| Denmark | Novo Nordisk Investigational Site | Århus C | |
| Denmark | Novo Nordisk Investigational Site | Esbjerg | |
| Denmark | Novo Nordisk Investigational Site | Gentofte | |
| Denmark | Novo Nordisk Investigational Site | Hellerup | |
| Denmark | Novo Nordisk Investigational Site | Hillerød | |
| Denmark | Novo Nordisk Investigational Site | Roskilde | |
| Denmark | Novo Nordisk Investigational Site | Slagelse | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Kuopio | |
| Finland | Novo Nordisk Investigational Site | Oulu | |
| Finland | Novo Nordisk Investigational Site | Turku | |
| Former Serbia and Montenegro | Novo Nordisk Investigational Site | Belgrade | |
| Former Serbia and Montenegro | Novo Nordisk Investigational Site | Nis | |
| France | Novo Nordisk Investigational Site | Besancon | |
| France | Novo Nordisk Investigational Site | Brest | |
| France | Novo Nordisk Investigational Site | Corbeil Essonnes | |
| France | Novo Nordisk Investigational Site | DIJON cedex | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| India | Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh |
| India | Novo Nordisk Investigational Site | Hyderabad | |
| India | Novo Nordisk Investigational Site | Karnal | Haryana |
| India | Novo Nordisk Investigational Site | Patna | |
| India | Novo Nordisk Investigational Site | Pune | Maharashtra |
| Italy | Novo Nordisk Investigational Site | Bergamo | |
| Italy | Novo Nordisk Investigational Site | Bologna | |
| Italy | Novo Nordisk Investigational Site | Catania | |
| Italy | Novo Nordisk Investigational Site | Catanzaro | |
| Italy | Novo Nordisk Investigational Site | Chieri | |
| Italy | Novo Nordisk Investigational Site | Chieti Scalo | |
| Italy | Novo Nordisk Investigational Site | Messina | |
| Italy | Novo Nordisk Investigational Site | Padova | |
| Italy | Novo Nordisk Investigational Site | Parma | |
| Italy | Novo Nordisk Investigational Site | Siena | |
| Netherlands | Novo Nordisk Investigational Site | Almere | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Den Helder | |
| Netherlands | Novo Nordisk Investigational Site | Eindhoven | |
| Netherlands | Novo Nordisk Investigational Site | Gouda | |
| Netherlands | Novo Nordisk Investigational Site | Maastricht | |
| Netherlands | Novo Nordisk Investigational Site | Zevenaar | |
| Netherlands | Novo Nordisk Investigational Site | Zoetermeer | |
| Norway | Novo Nordisk Investigational Site | Bergen | |
| Norway | Novo Nordisk Investigational Site | Gjettum | |
| Norway | Novo Nordisk Investigational Site | Jessheim | |
| Norway | Novo Nordisk Investigational Site | Nordbyhagen | |
| Norway | Novo Nordisk Investigational Site | Notodden | |
| Norway | Novo Nordisk Investigational Site | Sandvika | |
| Norway | Novo Nordisk Investigational Site | Skedsmokorset | |
| Philippines | Novo Nordisk Investigational Site | Cebu City | |
| Philippines | Novo Nordisk Investigational Site | Manila | |
| Philippines | Novo Nordisk Investigational Site | Marikina City | |
| Philippines | Novo Nordisk Investigational Site | Pasig City | |
| Poland | Novo Nordisk Investigational Site | Gdynia | |
| Poland | Novo Nordisk Investigational Site | Katowice | |
| Poland | Novo Nordisk Investigational Site | Opole | |
| Poland | Novo Nordisk Investigational Site | Poznan | |
| Poland | Novo Nordisk Investigational Site | Wroclaw | |
| Poland | Novo Nordisk Investigational Site | Zabrze | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Slovakia | Novo Nordisk Investigational Site | Banska Bystrica | |
| Slovakia | Novo Nordisk Investigational Site | Bratislava | |
| Slovakia | Novo Nordisk Investigational Site | L'ubochna | |
| Slovakia | Novo Nordisk Investigational Site | Martin | |
| Slovakia | Novo Nordisk Investigational Site | Nitra | |
| Slovakia | Novo Nordisk Investigational Site | Zilina | |
| South Africa | Novo Nordisk Investigational Site | Bloemfontein | Free State |
| South Africa | Novo Nordisk Investigational Site | Pretoria | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Pretoria | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Worcester | Western Cape |
| Spain | Novo Nordisk Investigational Site | Baracaldo | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Getafe | |
| Spain | Novo Nordisk Investigational Site | Málaga | |
| Spain | Novo Nordisk Investigational Site | Santiago de Compostela | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Spain | Novo Nordisk Investigational Site | Valencia | |
| Spain | Novo Nordisk Investigational Site | Valencia | |
| Spain | Novo Nordisk Investigational Site | Valencia | |
| Spain | Novo Nordisk Investigational Site | Valladolid | |
| United Kingdom | Novo Nordisk Investigational Site | Ayr | |
| United Kingdom | Novo Nordisk Investigational Site | Bradford | |
| United Kingdom | Novo Nordisk Investigational Site | Guildford | |
| United Kingdom | Novo Nordisk Investigational Site | Liverpool | |
| United Kingdom | Novo Nordisk Investigational Site | Livingstone | |
| United Kingdom | Novo Nordisk Investigational Site | Llantrisant | |
| United Kingdom | Novo Nordisk Investigational Site | Manchester | |
| United Kingdom | Novo Nordisk Investigational Site | Nottingham | |
| United Kingdom | Novo Nordisk Investigational Site | Salford | |
| United Kingdom | Novo Nordisk Investigational Site | Sheffield | |
| United Kingdom | Novo Nordisk Investigational Site | Swansea | |
| United Kingdom | Novo Nordisk Investigational Site | Watford |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Argentina, Austria, Brazil, Denmark, Finland, Former Serbia and Montenegro, France, India, Italy, Netherlands, Norway, Philippines, Poland, Russian Federation, Slovakia, South Africa, Spain, United Kingdom,
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 — View Citation
Buse JB, Peters A, Russell-Jones D, Furber S, Donsmark M, Han J, MacConell L, Maggs D, Diamant M. Is insulin the most effective injectable antihyperglycaemic therapy? Diabetes Obes Metab. 2015 Feb;17(2):145-51. doi: 10.1111/dom.12402. — 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
Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simó R; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group.. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonyl — 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, 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 | Beta-cell function | |||
| Secondary | Glycaemic control |
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