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:29
|
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
来源
DIABETES OBESITY & METABOLISM | 2016年 / 18卷 / 12期
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
相关论文
共 50 条
  • [31] Liraglutide as add-on to sodium-glucose co-transporter-2 inhibitors in patients with inadequately controlled type 2 diabetes: LIRA-ADD2SGLT2i, a 26-week, randomized, double-blind, placebo-controlled trial
    Blonde, Lawrence
    Belousova, Lidia
    Fainberg, Udi
    Garcia-Hernandez, Pedro A.
    Jain, Sunil M.
    Kaltoft, Margit S.
    Mosenzon, Ofri
    Nafach, Jalal
    Palle, Mads Sundby
    Rea, Rosangela
    DIABETES OBESITY & METABOLISM, 2020, 22 (06): : 929 - 937
  • [32] Efficacy and safety of Fengshi Gutong Capsule in patients with active ankylosing spondylitis: A 4-week randomized controlled, double-blinded, double-dummy trial
    Xie, Ya
    Tu, Liudan
    Zhang, Yanli
    Yu, Qinghong
    Wu, Henglian
    Ye, Shanhui
    Li, Haibo
    Chen, Zena
    Wu, Jialing
    Cao, Shuangyan
    Wei, Qiujing
    Gu, Jieruo
    JOURNAL OF ETHNOPHARMACOLOGY, 2022, 285
  • [33] Efficacy and safety of bexagliflozin compared with dapagliflozin as an adjunct to metformin in Chinese patients with type 2 diabetes mellitus: A 24-week, randomized, double-blind, active-controlled, phase 3 trial
    Xie, Lingding
    Han, Jie
    Cheng, Zhifeng
    Liu, Dexue
    Liu, Jie
    Xu, Chunrong
    Sun, Wenli
    Li, Qingju
    Bian, Fang
    Zhang, Wei
    Chen, Jinyu
    Zhu, Qian
    Thurber, Tara K.
    Lock, J. Paul
    Zhang, Bo
    JOURNAL OF DIABETES, 2024, 16 (04)
  • [34] Comparison of the efficacy and safety of CELBESTA® versus CELEBREX® in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trial
    Kim, Hyun-Sook
    Choi, Won-Ho
    Kim, Bo Young
    Kim, Sung Soo
    Lee, Sang-Il
    Kim, Sang-Hyon
    Choi, Sung Jae
    Kim, Geun-Tae
    Hur, Jin-Wuk
    Lee, Myeung-Su
    Kim, Yun Sung
    Hong, Seung-Jae
    JOURNAL OF INTERNATIONAL MEDICAL RESEARCH, 2020, 48 (06)
  • [35] Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial
    Barzilai, Nir
    Guo, Hua
    Mahoney, Erin M.
    Caporossi, Suzanne
    Golm, Gregory T.
    Langdon, Ronald B.
    Williams-Herman, Debora
    Kaufman, Keith D.
    Amatruda, John M.
    Goldstein, Barry J.
    Steinberg, Helmut
    CURRENT MEDICAL RESEARCH AND OPINION, 2011, 27 (05) : 1049 - 1058
  • [36] Efficacy of intravenous citalopram compared with oral citalopram for severe depression - Safety and efficacy data from a double-blind, double-dummy trial
    Guelfi, JD
    Strub, N
    Loft, H
    JOURNAL OF AFFECTIVE DISORDERS, 2000, 58 (03) : 201 - 209
  • [37] Efficacy and safety of a functionally selective insulin: a 26-week randomised, double blind trial versus insulin glargine in people with type 2 diabetes
    Heise, T.
    Haraldsson, H.
    Herbrand, T.
    Johansson, L.
    Jordan, J.
    Nishimura, E.
    Plum-Morschel, L.
    Tank, J.
    Thorisdottir, O.
    Lyby, K.
    DIABETOLOGIA, 2023, 66 (SUPPL 1) : S8 - S9
  • [38] BouNDless: An active-controlled randomized, double-blind double-dummy study of continuous ND0612 infusion in patients with fluctuating Parkinson's disease
    Poewe, W.
    Kieburtz, K.
    Stocchi, F.
    Oren, S.
    Yardeni, T.
    Adar, L.
    Rosenfeld, O.
    Olanow, C.
    MOVEMENT DISORDERS, 2019, 34 : S74 - S74
  • [39] Efficacy and Safety of Zhuanggu Joint Capsules in Combination with Celecoxib in Knee Osteoarthritis: A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Trial
    Zhang, Xian-Long
    Yang, Jing
    Yang, Liu
    Liu, Jian-Guo
    Cai, Xin-Yu
    Fan, Wei-Ming
    Yun, Xue-Qing
    Ma, Jin-Zhong
    Weng, Xi-Sheng
    CHINESE MEDICAL JOURNAL, 2016, 129 (08) : 891 - 897
  • [40] Efficacy and safety of Reduqing granules in the treatment of common cold with wind-heat syndrome:a randomized,double-blind,double-dummy,positive-controlled trial
    Ma Yanjiao
    Zhang Zhongyi
    Wei Lianbo
    He Shuai
    Deng Xun
    Ji Aimin
    Zhou Benjie
    Jiang Deqi
    Li Mingxing
    Wang Yong
    JournalofTraditionalChineseMedicine, 2017, 37 (02) : 185 - 192