title: Randomized trial showing efficacy and safety of twice-daily remogliflozin etabonate for the treatment of type 2 diabetes.
abstract: 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.
authors.affiliation: Metabolic Pathways and Cardiovascular, GlaxoSmithKline, Uxbridge, UK.
authors.forename: A P
authors.initials: AP
authors.lastname: Sykes
authors.forename: R
authors.initials: R
authors.lastname: O'Connor-Semmes
authors.forename: R
authors.initials: R
authors.lastname: Dobbins
authors.forename: D J
authors.initials: DJ
authors.lastname: Dorey
authors.forename: J D
authors.initials: JD
authors.lastname: Lorimer
authors.forename: S
authors.initials: S
authors.lastname: Walker
authors.forename: W O
authors.initials: WO
authors.lastname: Wilkison
authors.forename: L
authors.initials: L
authors.lastname: Kler
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D005960:Glucosides / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D015228:Hypertriglyceridemia / Q000150:complications / Q000517:prevention & control; D007003:Hypoglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D057194:Intention to Treat Analysis; D049990:Membrane Transport Modulators / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D010352:Patient Dropouts; D000077205:Pioglitazone; D011355:Prodrugs / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015431:Weight Loss / Q000187:drug effects
chemical_list: D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D049990:Membrane Transport Modulators; D000077205:Pioglitazone; D011355:Prodrugs; D011720:Pyrazoles; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D045162:Thiazolidinediones; C517652:hemoglobin A1c protein, human; C532127:remogliflozin etabonate
keywords: SGLT2; remogliflozin etabonate; type 2 diabetes