Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial

被引:31
作者
Bailey, T. S. [1 ]
Takacs, R. [2 ]
Tinahones, F. J. [3 ]
Rao, P. V. [4 ]
Tsoukas, G. M. [5 ]
Thomsen, A. B. [6 ]
Kaltoft, M. S. [6 ]
Maislos, M. [7 ]
机构
[1] AMCR Inst, Escondido, CA USA
[2] Univ Szeged, Dept Med 1, Szeged, Hungary
[3] Univ Malaga, Inst Salud Carlos 3, Hosp Virgen Victoria, Dept Clin Endocrinol & Nutr,IBIMA,CIBERobn, Malaga, Spain
[4] Ramdevrao Hosp, Kumudini Devi Diabet Res Ctr, Hyderabad, Telangana, India
[5] McGill Univ Hlth Ctr, Dept Endocrinol & Metab, Montreal, PQ, Canada
[6] Novo Nordisk AS, Global Dev Med & Sci, GLP 1 & Obes, Soborg, Denmark
[7] Ben Gurion Univ FOHS, Atherosclerosis & Metab Unit, Soroka UMC, Beer Sheva, Israel
关键词
liraglutide; sitagliptin; type; 2; diabetes; GLP-1 receptor agonist; DIPEPTIDYL PEPTIDASE-4 INHIBITOR; PEPTIDE-1 RECEPTOR AGONISTS; METFORMIN-TREATED PATIENTS; ONCE-DAILY LIRAGLUTIDE; HUMAN GLP-1 ANALOG; OPEN-LABEL; GLYCEMIC CONTROL; NON-INFERIORITY; EXENATIDE TWICE; PARALLEL-GROUP;
D O I
10.1111/dom.12736
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
AimsTo confirm superiority on glycaemic control by switching from sitagliptin to liraglutide 1.8mg/d versus continued sitagliptin. Materials and methodsA randomized, multicentre, double-blind, double-dummy, active-controlled trial across 86 office- or hospital-based sites in North America, Europe and Asia. Subjects with type 2 diabetes who had inadequate glycaemic control (glycated haemoglobin [HbA1c] 7.5-9.5% on sitagliptin (100mg/d) and metformin (1500mg daily) for 90days were randomized to either switch to liraglutide (n=203) or continue sitagliptin (n=204), both with metformin. The primary endpoint was change in HbA1c from baseline to week 26. Change in body weight was a confirmatory secondary endpoint. ResultsGreater reduction in mean HbA1c was achieved with liraglutide than with continued sitagliptin [-1.14% vs. -0.54%; estimated mean treatment difference (ETD): -0.61% (95% CI -0.82 to -0.40; p<0.0001)], confirming superiority of switching to liraglutide. Body weight was reduced more with liraglutide [-3.31kg vs. -1.64kg; ETD: -1.67kg (95% CI -2.34 to -0.99; p<0.0001)]. Nausea was more common with liraglutide [44 subjects (21.8%)] than with continued sitagliptin [16 (7.8%)]. Three subjects (1.5%) taking sitagliptin reported a confirmed hypoglycaemic episode. ConclusionsSubjects insufficiently controlled with sitagliptin who switch to liraglutide can obtain clinically relevant reductions in glycaemia and body weight, without compromising safety. A switch from sitagliptin to liraglutide provides an option for improved management of type 2 diabetes while still allowing patients to remain on dual therapy.
引用
收藏
页码:1191 / 1198
页数:8
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