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Randomized efficacy and safety trial of once‐daily remogliflozin etabonate for the treatment of type 2 diabetes
Author(s) -
Sykes A. P.,
Kemp G. L.,
Dobbins R.,
O'ConnorSemmes R.,
Almond S. R.,
Wilkison W. O.,
Walker S.,
Kler L.
Publication year - 2015
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12393
Subject(s) - tolerability , type 2 diabetes , placebo , medicine , randomized controlled trial , pioglitazone , clinical endpoint , diabetes mellitus , pharmacokinetics , pharmacology , adverse effect , endocrinology , alternative medicine , pathology
The sodium‐dependent glucose transporter 2 ( SGLT2 ) inhibitor remogliflozin etabonate ( RE ) was evaluated in a 12‐week, double‐blind, randomized, placebo‐ and active‐controlled, parallel‐group study. A total of 252 newly diagnosed and drug‐naïve people with type 2 diabetes and glycated haemoglobin ( HbA1c ) concentrations of 7.0–≤9.5% (53–80 mmol/mol) were recruited. Participants were randomized to RE (100, 250, 500 or 1000 mg once daily or 250 mg twice daily), placebo or 30 mg pioglitazone once daily. The primary endpoint was change in HbA1c concentration from baseline. Secondary endpoints included changes in fasting plasma glucose, body weight and lipid profiles, safety and tolerability. We observed a statistically significant trend in the RE dose–response relationship for change from baseline in HbA1c at week 12 (p < 0.047). RE was generally well tolerated and no effects on LDL cholesterol were observed.