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Clinical Trial Report

Liraglutide Effect and Action in Diabetes (LEAD™) trial

Pages 119-129 | Published online: 10 Jan 2014

References

  • Turner RC. The U.K. Prospective Diabetes Study. A review. Diabetes Care21(Suppl. 3), C35–C38 (1998).
  • Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with Type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA281(21), 2005–2012 (1999).
  • Nauck M, Stockmann F, Ebert R, Creutzfeldt W. Reduced incretin effect in Type 2 (non-insulin-dependent) diabetes. Diabetologia29(1), 46–52 (1986).
  • Vilsboll T, Holst JJ. Incretins, insulin secretion and Type 2 diabetes mellitus. Diabetologia47(3), 357–366 (2004).
  • Kjems LL, Holst JJ, Volund A, Madsbad S. The influence of GLP-1 on glucose-stimulated insulin secretion: effects on β-cell sensitivity in Type 2 and nondiabetic subjects. Diabetes52(2), 380–386 (2003).
  • Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology132(6), 2131–2157 (2007).
  • Zander M, Madsbad S, Madsen JL, Holst JJ. Effect of 6-week course of glucagon-like peptide 1 on glycaemic control, insulin sensitivity, and β-cell function in Type 2 diabetes: a parallel-group study. Lancet359(9309), 824–830 (2002).
  • Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care27(5), 1047–1053 (2004).
  • Bolen S, Feldman L, Vassy J et al. Systematic review: comparative effectiveness and safety of oral medications for Type 2 diabetes mellitus. Ann. Intern. Med.147(6), 386–399 (2007).
  • Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycemia in Type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care32(1), 193–203 (2009).
  • Kahn SE, Haffner SM, Heise MA et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N. Engl. J. Med.355(23), 2427–2443 (2006).
  • Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in Type 2 diabetes: systematic review and meta-analysis. JAMA298(2), 194–206 (2007).
  • Madsbad S, Krarup T, Deacon CF, Holst JJ. Glucagon-like peptide receptor agonists and dipeptidyl peptidase-4 inhibitors in the treatment of diabetes: a review of clinical trials. Curr. Opin. Clin. Nutr. Metab. Care11(4), 491–499 (2008).
  • Richter B, Bandeira-Echtler E, Bergerhoff K, Lerch CL. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus. Cochrane Database Syst. Rev. (2), CD006739 (2008).
  • Bloomgarden ZT, Dodis R, Viscoli CM, Holmboe ES, Inzucchi SE. Lower baseline glycemia reduces apparent oral agent glucose-lowering efficacy: a meta-regression analysis. Diabetes Care29(9), 2137–2139 (2006).
  • Agerso H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur. J. Pharm. Sci.19(2–3), 141–150 (2003).
  • Damholt B, Golor G, Wierich W, Pedersen P, Ekblom M, Zdravkovic M. An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide. J. Clin. Pharmacol.46(6), 635–641 (2006).
  • Nauck MA, Heimesaat MM, Behle K et al. Effects of glucagon-like peptide 1 on counterregulatory hormone responses, cognitive functions, and insulin secretion during hyperinsulinemic, stepped hypoglycemic clamp experiments in healthy volunteers. J. Clin. Endocrinol. Metab.87(3), 1239–1246 (2002).
  • Zdravkovic M, Ekblom M, Brondsted L, Vouis J, Lennerns H, Malm-Erjefalt M. The effect of liraglutide on the absorption phamacokinetics of concomitant oral drugs with different solubility and permeability properties in healthy subjects. Diabetologia51, S355 (2008).
  • Madsbad S, Schmitz O, Ranstam J, Jakobsen G, Matthews DR. Improved glycemic control with no weight increase in patients with Type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care27(6), 1335–1342 (2004).
  • Feinglos MN, Saad MF, Pi-Sunyer FX, An B, Santiago O. Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. Diabet. Med.22(8), 1016–1023 (2005).
  • Harder H, Nielsen L, Tu DT, Astrup A. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with Type 2 diabetes. Diabetes Care27(8), 1915–1921 (2004).
  • Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with Type 2 diabetes. Exp. Clin. Endocrinol. Diabetes114(8), 417–423 (2006).
  • Vilsboll T, Zdravkovic M, Le-Thi T et al. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with Type 2 diabetes. Diabetes Care30(6), 1608–1610 (2007).
  • Vilsboll T, Brock B, Perrild H et al. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic β-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus. Diabet. Med.25(2), 152–156 (2008).
  • Courreges JP, Vilsboll T, Zdravkovic M et al. Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes. Diabet. Med.25(9), 1129–1131 (2008).
  • Garber A, Henry R, Ratner R et al. Liraglutide versus glimepiride monotherapy for Type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, Phase III, double-blind, parallel-treatment trial. Lancet373(9662), 473–481 (2009).
  • Marre M, Show J, Brändle M et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic control and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet. Med. (2009) (In press).
  • Nauck M, Frid A, Hermansen K et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in Type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care32(1), 84–90 (2009).
  • Zinman B, Gerich J, Buse J et al. Effect of the GLP-1 analog liraglutide on glycemic control and weight reduction in patients on metformin and rosiglitazone : a randomized double-blind placebo-controlled trial. Diabetologia, 51(Suppl. 1), S359 (2007) (Abstract 898).
  • Russell-Jones D, Vaag A, Schmitz O et al. Significantly better glycemic control and weight reduction with liraglutide, a once-daily human GLP-1 analog, compared with insulin glargine: all as add-on to metformin and a sulfonylurea in Type 2 diabetes. Diabetes57, A159–A160 (2008).
  • Davies M, Lavalle-Gonzalez F, Storms F, Gomis R. Initiation of insulin glargine therapy in Type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes. Metab.10(5), 387–399 (2008).
  • Blonde L, Rosenstock J, Sesti G et al. Liraglutide: superior glycemic control vs exenatide when added to metformin and/or SU in Type 2 diabetes. Presented at: Canadian Diabetes Association Annual General Meeting. Montréal, QB, Canada, 16 October 2008.
  • Nauck M, Brandle M, Vaag A et al. The once-daily human GLP-1 analog liraglutide substantially reduces HbA(1c) in subjects with Type 2 diabetes, irrespective of HbA(1c) at baseline. Diabetes57, A594 (2008).
  • Russell-Jones D, Shaw JE, Brandle M et al. The once-daily human GLP-1 analog liraglutide reduces body weight in subjects with Type 2 diabetes, irrespective of body mass index at baseline. Diabetes57, A593–A594 (2008).
  • Colagiuri S, Frid A, Zdravkovic M, Le-Thi TD, Vaag A. The once-daily human GLP-1 analog-liraglutide reduces systolic blood pressure in patients with Type 2 diabetes. Diabetes57, A164–A165 (2008).
  • Matthews D, Marre M, Le-Thl TUD, Zdravkovic M, Simo R. Liraglutide, a once-daily human GLP-1 analog, significantly improves β-cell function in subjects with Type 2 diabetes. Diabetes57, A150–A151 (2008).
  • Service GJ, Thompson GB, Service FJ, Andrews JC, Collazo-Clavell ML, Lloyd RV. Hyperinsulinemic hypoglycemia with nesidioblastosis after gastric-bypass surgery. N. Engl. J. Med.353(3), 249–254 (2005).
  • Moreno C, Mistry M, Roman RJ. Renal effects of glucagon-like peptide in rats. Eur. J. Pharmacol.434(3), 163–167 (2002).
  • Davis SN, Johns D, Maggs D, Xu H, Northrup JH, Brodows RG. Exploring the substitution of exenatide for insulin in patients with Type 2 diabetes treated with insulin in combination with oral antidiabetes agents. Diabetes Care30(11), 2767–2772 (2007).

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