title: Randomized efficacy and safety trial of once-daily remogliflozin etabonate for the treatment of type 2 diabetes.
abstract: 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.
authors.affiliation: Metabolic Pathways and Cardiovascular, GlaxoSmithKline, Uxbridge, UK.
authors.forename: A P
authors.initials: AP
authors.lastname: Sykes
authors.forename: G L
authors.initials: GL
authors.lastname: Kemp
authors.forename: R
authors.initials: R
authors.lastname: Dobbins
authors.forename: R
authors.initials: R
authors.lastname: O'Connor-Semmes
authors.forename: S R
authors.initials: SR
authors.lastname: Almond
authors.forename: W O
authors.initials: WO
authors.lastname: Wilkison
authors.forename: S
authors.initials: S
authors.lastname: Walker
authors.forename: L
authors.initials: L
authors.lastname: Kler
mesh_terms: D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / 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*; 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; glycaemic control; remogliflozin etabonate; type 2 diabetes