Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus.

Objective: To assess the efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes (T2DM).Methods: Analysis of data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies. Ertugliflozin efficacy was evaluated when initiated as a single agent (as monotherapy or add-on therapy) and when initiated in combination with sitagliptin. Least-squares mean change from baseline was calculated for glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs). The Clinicaltrials.gov identifiers are NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.Results: Analyses included 1178 Hispanic/Latino patients. In a pooled analysis of three placebo-controlled studies where ertugliflozin was initiated as a single agent, the placebo-corrected change from baseline in HbA1c at Week 26 for ertugliflozin 5 mg and 15 mg was -0.8% and -1.0%. In an active-comparator study, when initiated as a single agent, the change from baseline in HbA1c at Week 52 was -0.5%, -0.7%, and -0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg, and glimepiride, respectively. In a placebo-controlled study, when initiated in combination with sitagliptin, the placebo-corrected change from baseline in HbA1c at Week 26 for ertugliflozin 5 mg/sitagliptin and ertugliflozin 15 mg/sitagliptin was -1.3% and -1.6%, respectively. In an active-comparator study, when initiated in combination with sitagliptin, the change from baseline in HbA1c at Week 26 was -1.4%, -1.6%, and -0.9% for ertugliflozin 5 mg/sitagliptin, ertugliflozin 15 mg/sitagliptin, and sitagliptin alone, respectively. Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin. The incidences of overall and prespecified AEs in Hispanic/Latino patients were generally consistent with the known safety profile of ertugliflozin.Conclusion: Ertugliflozin, administered as a single agent or as combination with sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally well-tolerated in Hispanic/Latino patients with T2DM.