Diabetes Mellitus, Type 2 Clinical Trial
— LEAD-1Official title:
Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy 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 globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.
| Status | Completed |
| Enrollment | 1041 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 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: 7.0-11.0 % (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 45.0 kg/m2. Exclusion Criteria: - Treatment with insulin within the last three months - Treatment with any drug that could interfere with the glucose level - Any serious medical condition - Females who are pregnant, have the intention of becoming pregnant or are breastfeeding |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Córdoba | |
| Argentina | Novo Nordisk Investigational Site | Mar del Plata | |
| Argentina | Novo Nordisk Investigational Site | Mendoza | |
| Australia | Novo Nordisk Investigational Site | Caboolture | |
| Australia | Novo Nordisk Investigational Site | Ingleburn | |
| Australia | Novo Nordisk Investigational Site | Kippa Ring | |
| Australia | Novo Nordisk Investigational Site | Melbourne | Victoria |
| Australia | Novo Nordisk Investigational Site | Miranda | |
| Australia | Novo Nordisk Investigational Site | Randwick | |
| Australia | Novo Nordisk Investigational Site | Southport | |
| Australia | Novo Nordisk Investigational Site | Stones Corner | |
| Australia | Novo Nordisk Investigational Site | Woolloongabba | Queensland |
| Brazil | Novo Nordisk Investigational Site | Fortaleza | |
| Brazil | Novo Nordisk Investigational Site | Sao Paulo | |
| Bulgaria | Novo Nordisk Investigational Site | Pleven | |
| Bulgaria | Novo Nordisk Investigational Site | Plovdiv | |
| Bulgaria | Novo Nordisk Investigational Site | Russe | |
| Bulgaria | Novo Nordisk Investigational Site | Sofia | |
| Bulgaria | Novo Nordisk Investigational Site | Sofia | |
| Bulgaria | Novo Nordisk Investigational Site | Varna | |
| Croatia | Novo Nordisk Investigational Site | Osijek | |
| Croatia | Novo Nordisk Investigational Site | Slavonski Brod | |
| Croatia | Novo Nordisk Investigational Site | Split | |
| Czech Republic | Novo Nordisk Investigational Site | Brno | |
| Czech Republic | Novo Nordisk Investigational Site | Hradec Králové | |
| Czech Republic | Novo Nordisk Investigational Site | Ostrava | |
| Czech Republic | Novo Nordisk Investigational Site | Plzen - Lochotin | |
| Czech Republic | Novo Nordisk Investigational Site | Prague 4 | |
| Czech Republic | Novo Nordisk Investigational Site | Praha 10 | |
| Czech Republic | Novo Nordisk Investigational Site | Praha 5 | |
| Finland | Novo Nordisk Investigational Site | Espoo | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Lahti | |
| Finland | Novo Nordisk Investigational Site | Nurmijärvi | |
| Finland | Novo Nordisk Investigational Site | Oulu | |
| Finland | Novo Nordisk Investigational Site | Pieksämäki | |
| Finland | Novo Nordisk Investigational Site | Rauma | |
| Finland | Novo Nordisk Investigational Site | Rovaniemi | |
| Finland | Novo Nordisk Investigational Site | Tampere | |
| Finland | Novo Nordisk Investigational Site | Tampere | |
| France | Novo Nordisk Investigational Site | DAX | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Montpellier | |
| France | Novo Nordisk Investigational Site | Mougins | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Rennes | |
| France | Novo Nordisk Investigational Site | Saint Mandé | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| India | Novo Nordisk Investigational Site | Chandigarh | Punjab |
| India | Novo Nordisk Investigational Site | Chennai | |
| India | Novo Nordisk Investigational Site | Mumbai | |
| India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
| Israel | Novo Nordisk Investigational Site | Haifa | |
| Israel | Novo Nordisk Investigational Site | Jerusalem | |
| Israel | Novo Nordisk Investigational Site | Tel Hashomer | |
| Italy | Novo Nordisk Investigational Site | Catania | |
| Italy | Novo Nordisk Investigational Site | Lucca | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Napoli | |
| Italy | Novo Nordisk Investigational Site | Perugia | |
| Italy | Novo Nordisk Investigational Site | Ravenna | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Torino | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Malaysia | Novo Nordisk Investigational Site | Cheras | |
| Malaysia | Novo Nordisk Investigational Site | Kota Bharu, Kelantan | |
| Malaysia | Novo Nordisk Investigational Site | Pulau Pinang | |
| Philippines | Novo Nordisk Investigational Site | Davao City | |
| Philippines | Novo Nordisk Investigational Site | Makati City | |
| Philippines | Novo Nordisk Investigational Site | Marikina City | |
| Philippines | Novo Nordisk Investigational Site | Quezon City | |
| Poland | Novo Nordisk Investigational Site | Bytom | |
| Poland | Novo Nordisk Investigational Site | Gdansk | |
| Poland | Novo Nordisk Investigational Site | Gniewkowo | |
| Poland | Novo Nordisk Investigational Site | Kamieniec Zabkowicki | |
| Poland | Novo Nordisk Investigational Site | Krakow | |
| Poland | Novo Nordisk Investigational Site | Lodz | |
| Poland | Novo Nordisk Investigational Site | Lublin | |
| Poland | Novo Nordisk Investigational Site | Lublin | |
| Poland | Novo Nordisk Investigational Site | Mazowieckie | |
| Poland | Novo Nordisk Investigational Site | Nysa | |
| Poland | Novo Nordisk Investigational Site | Rawa Mazowiecka | |
| Poland | Novo Nordisk Investigational Site | Szczecin | |
| Poland | Novo Nordisk Investigational Site | Tychy | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| Poland | Novo Nordisk Investigational Site | Zabrze | |
| Romania | Novo Nordisk Investigational Site | Baia Mare | |
| Romania | Novo Nordisk Investigational Site | Brasov | |
| Romania | Novo Nordisk Investigational Site | Bucharest | |
| Romania | Novo Nordisk Investigational Site | Ploiesti | Prahova |
| Romania | Novo Nordisk Investigational Site | Timisoara | |
| South Africa | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Umhlanga | |
| Spain | Novo Nordisk Investigational Site | Gijón | |
| Spain | Novo Nordisk Investigational Site | Palma de Mallorca | |
| Spain | Novo Nordisk Investigational Site | Reus | |
| Switzerland | Novo Nordisk Investigational Site | Bern | |
| Switzerland | Novo Nordisk Investigational Site | Lausanne | |
| Switzerland | Novo Nordisk Investigational Site | St. Gallen | |
| Switzerland | Novo Nordisk Investigational Site | Zürich | |
| Switzerland | Novo Nordisk Investigational Site | Zürich | |
| Taiwan | Novo Nordisk Investigational Site | Changhua | |
| Taiwan | Novo Nordisk Investigational Site | Kaohsiung City | |
| Taiwan | Novo Nordisk Investigational Site | Taipei | |
| Taiwan | Novo Nordisk Investigational Site | Taipei | |
| Thailand | Novo Nordisk Investigational Site | Bangkok | |
| Thailand | Novo Nordisk Investigational Site | Bangkok | |
| Thailand | Novo Nordisk Investigational Site | Bangkok | |
| Turkey | Novo Nordisk Investigational Site | Ankara | |
| Turkey | Novo Nordisk Investigational Site | Antalya | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| Turkey | Novo Nordisk Investigational Site | Izmir |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Argentina, Australia, Brazil, Bulgaria, Croatia, Czech Republic, Finland, France, Greece, India, Israel, Italy, Korea, Republic of, Malaysia, Philippines, Poland, Romania, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey,
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
Hegedüs 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 t — 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
Marre M, Shaw J, Brändle M, Bebakar WM, Kamaruddin NA, Strand J, Zdravkovic M, Le Thi TD, Colagiuri S; LEAD-1 SU study group.. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemi — 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
Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997. — 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, 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 14 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 | Glycemic control parameters (fasting plasma glucose, -glucose profiles) |
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