Abstract
The aim of the present study was to evaluate the safety and efficacy of luseogliflozin added to liraglutide monotherapy in Japanese individuals with type 2 diabetes. This 52-week, multicenter, open-label, single-arm clinical study enrolled Japanese patients who had inadequate glycemic control with diet/exercise and liraglutide monotherapy. Major efficacy end-points included the changes from baseline in glycated hemoglobin, fasting plasma glucose and bodyweight. Body composition was also assessed in individuals who had access to bioelectrical impedance analysis. Safety assessments included adverse events, clinical laboratory tests, vital signs and 12-lead electrocardiograms. Of 76 patients who received luseogliflozin, 62 completed the study. The changes from baseline in glycated hemoglobin, fasting plasma glucose, and bodyweight (mean ± SE) were -0.68 ± 0.10%, -32.1 ± 3.6 mg/dL and -2.71 ± 0.24 kg at week 52, respectively (all, P < 0.001 vs baseline). Luseogliflozin was associated with greater reductions in fat mass than lean mass at all measuring points (n = 22): fat vs lean mass changes (mean ± SE) at week 52 were -2.49 ± 0.45 kg (P < 0.001 vs baseline) and -0.44 ± 0.26 kg (P = 0.107 vs baseline), respectively. Insulin secreti...Continue Reading
References
Mar 1, 1992·Diabetes·E Van CauterK S Polonsky
Sep 10, 1999·Diabetes Care·M Matsuda, R A DeFronzo
Mar 28, 2002·The American Journal of Clinical Nutrition·Ian JanssenRobert Ross
Jul 28, 2004·The American Journal of Clinical Nutrition·Samuel KleinUNKNOWN American Society for Clinical Nutrition
Jul 28, 2004·Diabetes Care·Samuel KleinUNKNOWN American Society for Clinical Nutrition
Jun 10, 2008·The New England Journal of Medicine·UNKNOWN Action to Control Cardiovascular Risk in Diabetes Study GroupWilliam T Friedewald
Oct 12, 2010·The New England Journal of Medicine·Sophia ZoungasUNKNOWN ADVANCE Collaborative Group
Jan 13, 2012·The Journal of Clinical Endocrinology and Metabolism·Jan BolinderShamik Parikh
Aug 7, 2012·Diabetes, Obesity & Metabolism·K NiswenderB Zinman
Jul 16, 2013·Lancet·William T CefaluGary Meininger
Apr 9, 2014·Current Medical Research and Opinion·Yutaka SeinoYoshishige Samukawa
Nov 30, 2011·Journal of Diabetes Investigation·Kohei KakuYutaka Seino
May 21, 2014·Journal of Diabetes Investigation·Yoshihito Fujita, Nobuya Inagaki
Apr 9, 2015·Expert Opinion on Drug Safety·Daisuke YabeYutaka Seino
Apr 29, 2015·Current Medical Research and Opinion·Daisuke YabeYutaka Seino
May 7, 2015·Current Diabetes Reports·Daisuke YabeSusumu Seino
May 15, 2015·Endocrine Journal·Yutaka SeinoYoshishige Samukawa
Jul 30, 2015·Journal of Diabetes Investigation·Yutaka SeinoYoshishige Samukawa
Oct 28, 2015·Biochemical and Biophysical Research Communications·Seizo OkauchiHideaki Kaneto
Mar 30, 2016·Clinical Therapeutics·Soichi SakaiYoshishige Samukawa
Sep 22, 2016·The Lancet. Diabetes & Endocrinology·Juan P FríasSerge A Jabbour
Citations
Feb 17, 2018·Current Medical Research and Opinion·Yutaka SeinoSoichi Sakai
Feb 24, 2018·Diabetes, Obesity & Metabolism·Shin-Ichi HarashimaYumi Watanabe
Apr 17, 2018·Journal of Diabetes Investigation·Takashi SasakiMasahiro Fukuda
Jun 22, 2018·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Hisamitsu IshiharaTaishi Sakatani
Sep 22, 2019·Journal of Diabetes Investigation·Yoshihito Fujita, Nobuya Inagaki
Aug 28, 2019·Expert Opinion on Pharmacotherapy·Masahiro Takihata, Yasuo Terauchi
Jan 10, 2018·Diabetes, Obesity & Metabolism·Ren MatsubaYasushi Tanaka
Apr 25, 2020·Journal of the American Heart Association·Ignatios IkonomidisVaia Lambadiari
Jul 26, 2019·BMJ Open·Steve KantersEric Druyts
Apr 13, 2020·Journal of Diabetes Investigation·Hirotatsu NakaguchiYasuo Terauchi
Oct 1, 2019·Endocrinology and Metabolism·Jack Alistair SargeantMelanie Jane Davies
May 30, 2020·Journal of Diabetes Investigation·Yusei Hosokawa, Wataru Ogawa
Jul 26, 2017·Expert Opinion on Drug Safety·Daisuke YabeYutaka Seino
Nov 4, 2017·Clinical Drug Investigation·Noboru KurinamiHideaki Jinnouchi
Mar 22, 2019·Case Reports in Endocrinology·Miyako KishimotoMasayuki Adachi
Feb 26, 2020·Diabetes & Metabolism Journal·Wayne Huey Herng SheuKun Ho Yoon
Oct 4, 2019·Postgraduate Medicine·Rosemarie Lajara
May 30, 2020·Journal of Clinical Medicine·Adrian PostStephan J L Bakker
Mar 27, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Yasuo TerauchiJisoo Lee
Dec 12, 2018·Journal of Diabetes Investigation·Hideka InoueUNKNOWN SUMS-ADDIT-1 Research group
Aug 24, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Taichi Nagahisa, Yoshifumi Saisho
Feb 16, 2021·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Haleh ChehrehgoshaMohammad E Khamseh
May 20, 2020·Diabetes Spectrum : a Publication of the American Diabetes Association·John E Anderson