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Randomized trial showing efficacy and safety of twice‐daily remogliflozin etabonate for the treatment of type 2 diabetes
Author(s) -
Sykes A. P.,
O'ConnorSemmes R.,
Dobbins R.,
Dorey D. J.,
Lorimer J. D.,
Walker S.,
Wilkison W. O.,
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.12391
Subject(s) - placebo , tolerability , pioglitazone , medicine , type 2 diabetes , randomized controlled trial , clinical endpoint , diabetes mellitus , adverse effect , endocrinology , alternative medicine , pathology
We compared the efficacy of twice‐daily doses of remogliflozin etabonate ( RE ) and once‐daily pioglitazone with placebo for reduction in glycated haemoglobin ( HbA1c ) concentration. In this 12‐week, double‐blind, randomized, active‐ and placebo‐controlled trial, 336 treatment‐naïve subjects with type 2 diabetes and an HbA1c of 7.0–9.5% (53–80 mmol/mol) were randomized to RE (50, 100, 250, 500 or 1000 mg twice daily), matching placebo or 30 mg pioglitazone once daily. The primary endpoint was change in HbA1c from baseline. Other endpoints included changes in body weight, lipid levels, safety and tolerability. RE produced a decreasing dose response in HbA1c at week 12 (p < 0.001), with reductions in HbA1c versus placebo ranging from 0.64 to 1.07% (p < 0.001). Statistically significant reductions in body weight for RE compared with placebo were also observed. Twice‐daily RE resulted in a dose‐ordered improvement in glycaemic control and was generally well tolerated.