Randomized efficacy and safety trial of once-daily remogliflozin etabonate for the treatment of type 2 diabetes

• Published in: Diabetes, obesity & metabolism Vol. 17; no. 1; pp. 98 - 101
• Main Authors: Sykes, A. P., Kemp, G. L., Dobbins, R., O'Connor-Semmes, R., Almond, S. R., Wilkison, W. O., Walker, S., Kler, L.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.01.2015; Wiley Subscription Services, Inc
• Subjects: Body weight; Cholesterol; Cohort Studies; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug therapy; Follow-Up Studies; Glucose transporter; Glucosides - administration & dosage; Glucosides - adverse effects; Glucosides - therapeutic use; glycaemic control; Glycated Hemoglobin A - analysis; Hemoglobin; Humans; Hyperglycemia - prevention & control; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Intention to Treat Analysis; Low density lipoprotein; Membrane Transport Modulators - administration & dosage; Membrane Transport Modulators - adverse effects; Membrane Transport Modulators - therapeutic use; Middle Aged; Patient Dropouts; Pioglitazone; Placebos; Prodrugs - administration & dosage; Prodrugs - adverse effects; Prodrugs - therapeutic use; Pyrazoles - administration & dosage; Pyrazoles - adverse effects; Pyrazoles - therapeutic use; remogliflozin etabonate; SGLT2; Sodium-glucose cotransporter; Sodium-Glucose Transporter 2 - antagonists & inhibitors; Statistical analysis; Thiazolidinediones - administration & dosage; Thiazolidinediones - adverse effects; Thiazolidinediones - therapeutic use; type 2 diabetes; Weight Loss - drug effects; glycaemic control; type 2 diabetes; remogliflozin etabonate; SGLT2
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.12393

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.