Proportion of participants with type 2 diabetes achieving a metabolic composite endpoint with once-weekly semaglutide treatment versus comparators: Post hoc pooled analysis from SUSTAIN 1-5, 7-10 and SUSTAIN China

被引:2
作者
Ji, Linong [1 ,9 ]
Ahmann, A. J. [2 ]
Ahren, B. [3 ]
Capehorn, M. S. [4 ]
Hu, P. [5 ]
Lingvay, I. [6 ]
Liu, W. [5 ]
Rodbard, H. W. [7 ]
Shen, Z. [5 ]
Sorli, C. [8 ]
机构
[1] Peking Univ Peoples Hosp, Beijing, Peoples R China
[2] Oregon Hlth & Sci Univ, Portland, OR USA
[3] Lund Univ, Lund, Sweden
[4] Clifton Med Ctr, Rotherham, England
[5] Novo Nordisk Shanghai Pharm Trading Co Ltd, Beijing, Peoples R China
[6] Univ Texas Southwestern Med Ctr, Dallas, TX USA
[7] Endocrine & Metab Consultants, Rockville, MD USA
[8] Acerus Pharm, Toronto, ON, Canada
[9] Peking Univ Peoples Hosp, Dept Endocrinol & Metab, Beijing 100044, Peoples R China
关键词
cardiovascular disease; clinical trial; diabetes complications; GLP-1; analogue; semaglutide; type; 2; diabetes; OPEN-LABEL; PHASE; 3A; ADD-ON; DAILY SITAGLIPTIN; DOUBLE-BLIND; EFFICACY; SAFETY; METFORMIN; 56-WEEK; DISEASE;
D O I
10.1111/dom.15309
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aim: To compare the proportion of participants with type 2 diabetes (T2D) treated with once-weekly (OW) subcutaneous (SC) semaglutide versus comparators who achieved a composite metabolic endpoint.Materials and Methods: SUSTAIN 1-5, 7-10 and SUSTAIN China trial data were pooled. Participants with T2D (aged >= 18 years) and glycated haemoglobin >= 7.0% (>= 53 mmol/mol) who had been randomized to OW SC semaglutide (0.5 or 1.0 mg) or comparator in addition to background medication. Using patient-level data pooled by treatment, proportions of participants achieving the metabolic composite endpoint, defined as glycated haemoglobin <7% (<53 mmol/mol), blood pressure <140/90 mmHg and non-high-density lipoprotein cholesterol <130 mg/dl (<3.37 mmol/L), were evaluated following baseline adjustments. Endpoints were analysed per trial using a binomial logistic regression model with treatment, region/country and stratification factor as fixed effects and baseline value as covariate. Pooled analysis used logistic regression with treatment and trial as fixed effects and baseline value as covariate.Results: This post hoc analysis included data from 7633 participants across 10 trials. The proportion of participants who achieved the metabolic composite endpoint was significantly higher with OW SC semaglutide 0.5 and 1.0 mg versus comparators (23.7% and 32.0% vs. 11.5%, respectively; p < .0001). Likewise, when the OW SC semaglutide doses were pooled, significantly higher proportions of patients receiving semaglutide achieved the composite metabolic endpoint versus comparators (29.1% vs. 11.4%, respectively; p < .0001).Conclusions: Treatment with OW SC semaglutide versus comparators was associated with increased proportions of participants with T2D meeting the composite metabolic endpoint.
引用
收藏
页码:233 / 241
页数:9
相关论文
共 28 条
[1]  
ACC, CARD IN
[2]   Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial [J].
Ahmann, Andrew J. ;
Capehorn, Matthew ;
Charpentier, Guillaume ;
Dotta, Francesco ;
Henkel, Elena ;
Lingvay, Ildiko ;
Holst, Anders G. ;
Annett, Miriam P. ;
Aroda, Vanita R. .
DIABETES CARE, 2018, 41 (02) :258-266
[3]   Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial [J].
Ahren, Bo ;
Masmiquel, Luis ;
Kumar, Harish ;
Sargin, Mehmet ;
Karsbol, Julie Derving ;
Jacobsen, Sanja Hald ;
Chow, Francis .
LANCET DIABETES & ENDOCRINOLOGY, 2017, 5 (05) :341-354
[4]  
American Diabetes Association, 2022, Clin Diabetes, V41, P4, DOI 10.2337/cd23-as01
[5]  
Anto EO., 2022, FRONT CLIN DIABETES, V2
[6]   Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials [J].
Aroda, V. R. ;
Ahmann, A. ;
Cariou, B. ;
Chow, F. ;
Davies, M. J. ;
Jodar, E. ;
Mehta, R. ;
Woo, V ;
Lingvay, I .
DIABETES & METABOLISM, 2019, 45 (05) :409-418
[7]   Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial [J].
Aroda, Vanita R. ;
Bain, Stephen C. ;
Cariou, Bertrand ;
Piletic, Milivoj ;
Rose, Ludger ;
Axelsen, Mads ;
Rowe, Everton ;
DeVries, J. Hans .
LANCET DIABETES & ENDOCRINOLOGY, 2017, 5 (05) :355-366
[8]   Efficacy and safety of once-weekly semaglutide 1.0 mg vs once-daily liraglutide 1.2 mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10) [J].
Capehorn, M. S. ;
Catarig, A-M ;
Furberg, J. K. ;
Janez, A. ;
Price, H. C. ;
Tadayon, S. ;
Verges, B. ;
Marre, M. .
DIABETES & METABOLISM, 2020, 46 (02) :100-109
[9]   Roles of Cardiometabolic Factors in Mediating the Causal Effect of Type 2 Diabetes on Cardiovascular Diseases: A Two-Step, Two-Sample Multivariable Mendelian Randomization Study [J].
Chen, Ken ;
Zhuang, Zhenhuang ;
Shao, Chunli ;
Zheng, Jilin ;
Zhou, Qing ;
Dong, Erdan ;
Huang, Tao ;
Tang, Yi-Da .
FRONTIERS IN CARDIOVASCULAR MEDICINE, 2022, 9
[10]  
[中华医学会糖尿病学分会 Chinese Diabetes Society], 2021, [中华内分泌代谢杂志, Chinese Journal of Endocrinology and Metabolism], V37, P311