Abstract
This phase 2, double-blind, randomized, placebo-controlled trial (ClinicalTrials.gov NCT02702011) with 4 sites in Japan investigated the pharmacodynamics (PD), pharmacokinetics (PK) and safety profile of empagliflozin in Japanese participants with type 1 diabetes mellitus (T1DM) as adjunctive therapy to insulin. Participants using multiple daily injections of insulin for ≥12 months, with HbA1c of 7.5%-10.0%, entered a 2-week, open-label, placebo run-in period, followed by a 4-week, double-blind period during which participants were randomized 1:1:1:1 to receive empagliflozin 2.5 mg (n = 13), empagliflozin 10 mg (n = 12), empagliflozin 25 mg (n = 12) or placebo (n = 11). The primary objective was to assess the effect of empagliflozin vs placebo on urinary glucose excretion (UGE) after 7 days of treatment. PD: Empagliflozin resulted in a dose-dependent significant increase in 24-hour UGE compared with placebo (UGE placebo-corrected mean [95% confidence interval] change from baseline: 2.5 mg, 65.10 [43.29, 86.90] g/24 h; 10 mg, 81.19 [58.80, 103.58] g/24 h; 25 mg, 98.11 [75.91, 120.31] g/24 h). After 4 weeks of treatment, UGE increase was associated with improved glycaemic control, reduced body weight and decreased insulin needs. ...Continue Reading
References
Apr 3, 2009·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Seiichi MatsuoUNKNOWN Collaborators developing the Japanese equation for estimated GFR
Oct 12, 2011·Diabetes, Obesity & Metabolism·R GremplerP Eickelmann
Sep 15, 2012·Diabetes, Obesity & Metabolism·E ZijlstraS Heckermann
May 7, 2013·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Philip HomeAlexey Zilov
Feb 18, 2014·Diabetes Research and Clinical Practice·Suzanne GeerlingsShamik Parikh
Mar 7, 2014·Diabetes Care·Bruce A PerkinsOdd-Erik Johansen
May 21, 2014·Journal of Diabetes Investigation·Shigeto KanadaHans J Woerle
Jan 31, 2015·Cardiovascular Diabetology·Rimei NishimuraUli C Broedl
Jun 18, 2015·Diabetes, Obesity & Metabolism·T R PieberS Kaspers
Sep 18, 2015·The New England Journal of Medicine·Bernard ZinmanUNKNOWN EMPA-REG OUTCOME Investigators
Oct 22, 2015·Diabetes Care·Robert R HenryMaria Alba
Mar 13, 2016·The Lancet. Diabetes & Endocrinology·Christian Seerup FrandsenSten Madsbad
Apr 3, 2016·Free Radical Biology & Medicine·Preeti Kanikarla-Marie, Sushil K Jain
Jun 15, 2016·The New England Journal of Medicine·Christoph WannerUNKNOWN EMPA-REG OUTCOME Investigators
Aug 11, 2016·Diabetes Care·Chantal MathieuUNKNOWN ADJUNCT ONE Investigators
Dec 3, 2016·Diabetes Care·Helena W RodbardMaria Alba
Dec 9, 2016·Diabetes Technology & Therapeutics·Susanne FamullaStefan Kaspers
Dec 28, 2016·Circulation Journal : Official Journal of the Japanese Circulation Society·Kohei KakuUNKNOWN EMPA-REG OUTCOME® Investigators
Feb 2, 2017·Pediatric Diabetes·Reem A Al KhalifahIvan D Florez
Apr 2, 2017·Current Diabetes Reports·Ketan K Dhatariya, Priyathama Vellanki
Apr 19, 2017·Diabetes, Obesity & Metabolism·Torben BiesterThomas Danne
Apr 22, 2017·Nature Reviews. Endocrinology·Chantal MathieuKatrien Benhalima
May 19, 2017·Diabetes, Obesity & Metabolism·Benedetta Maria BonoraGian Paolo Fadini
May 28, 2017·Diabetes Care·Rose A Gubitosi-KlugUNKNOWN Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Gro
Jun 16, 2017·The Lancet. Diabetes & Endocrinology·John R PetrieUNKNOWN REMOVAL Study Group
Sep 14, 2017·The New England Journal of Medicine·Satish K GargPaul Strumph
Sep 19, 2017·The Lancet. Diabetes & Endocrinology·Paresh DandonaUNKNOWN DEPICT-1 Investigators
Oct 17, 2017·Oncotarget·Yong-Chao QiaoHai-Lu Zhao
Citations
Oct 6, 2018·Diabetes Care·Julio RosenstockBruce A Perkins
Dec 20, 2018·Journal of Diabetes·Kexin Li, Gaosi Xu
May 14, 2019·Diabetes, Obesity & Metabolism·Torben BiesterThomas Danne
Jun 23, 2019·The Annals of Pharmacotherapy·Kajal Patel, Antonia Carbone
Oct 24, 2019·Diabetes Technology & Therapeutics·Ane Bayona CebadaManuel Luque-Ramírez
Jun 28, 2020·Journal of Diabetes Investigation·Koki ChibaHideaki Miyoshi
May 21, 2019·International Heart Journal·Tomonari KimuraHiroshi Ito
May 22, 2020·Diabetes, Obesity & Metabolism·Weihao WangLixin Guo
Dec 30, 2020·PLoS Medicine·Giovanni MussoRoberto Gambino
Nov 17, 2020·BMC Medicine·Chu LinLinong Ji
Mar 3, 2021·Acta Diabetologica·Lunwen RaoXuefeng Li
Feb 24, 2021·Diabetes, Obesity & Metabolism·Eiichi ArakiNayyar Iqbal
May 1, 2021·Pharmaceutics·Curtis K JohnstonKarl-Heinz Liesenfeld
Jul 1, 2021·Scientific Reports·Junichi MukaiRie Kubota
Aug 18, 2021·Expert Opinion on Pharmacotherapy·Stavroula Veneti, Konstantinos Tziomalos
Aug 3, 2021·Endocrine Journal·Masashi ShimodaHideaki Kaneto