4 research outputs found
Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus
Introduction: Two studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy. Materials and Methods: In the trial involving addâon to sulfonylureas (study 03â1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24âweek doubleâblind period, followed by a 28âweek openâlabel period. In the openâlabel trial involving addâon to other OADs; that is, biguanides, dipeptidyl peptidaseâ4 inhibitors, thiazolidinediones, glinides and Îąâglucosidase inhibitors (study 03â2), patients received luseogliflozin for 52 weeks. Results: In study 03â1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24âweek doubleâblind period compared with the placebo (â0.88%, P < 0.001), and glycated hemoglobin reduction from baseline at week 52 was â0.63%. In study 03â2, luseogliflozin added to other OADs significantly decreased glycated hemoglobin from baseline at week 52 (â0.52 to â0.68%, P < 0.001 for all OADs). Bodyweight reduction was observed in all addâon therapies, even with agents associated with weight gain, such as sulfonylureas and thiazolidinediones. Most adverse events were mild in severity. When added to a sulfonylurea, incidences of hypoglycemia during the doubleâblind period were 8.7% and 4.2% for luseogliflozin and placebo, respectively, but no major hypoglycemic episodes occurred. The frequency and incidences of adverse events of special interest for sodium glucose cotransporter 2 inhibitors and adverse events associated with combined OADs were acceptable. Conclusions: Addâon therapies of luseogliflozin to existing OADs improved glycemic control, reduced bodyweight and were well tolerated in Japanese type 2 diabetic patients. These trials were registered with the Japan Pharmaceutical Information Center (add on to sulfonylurea: JapicCTIâ111507; add on to other OADs: JapicCTIâ111508)