Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus

Abstract

Background To evaluate the efficacy and safety of glimepiride plus insulin glargine in ethnic Japanese patients with type 2 diabetes mellitus (T2DM). Methods This 24-week, open-label, single-arm study was conducted in eight centers in Brazil. One hundred ethnic Japanese T2DM patients with inadequate glycemic control [HbA 1c: 8.0–11.0% and fasting plasma glucose (FPG) ≥ 140 mg/dL] on oral antidiabetic drugs (OADs) were enrolled. Patients were treated once daily with glimepiride 3 mg (morning) and glargine (bedtime) with dose titration to achieve FPG 72–100 mg/dL. Results At Week 24, the mean dose of glargine was 37.6 IU/day. There were significant decreases ( p < 0.0001) compared with baseline, for mean HbA 1c (1.5%), mean FPG (88.3 mg/dL) ( p < 0.0001), mean PPG (112.0 mg/dL), and mean fasting C-peptide (1.14 ng/mL). Peptide index (peak − basal/basal) in carbohydrate challenge test increased by 2.24 units. No severe adverse events, including severe hypoglycemia were reported. Conclusions Our study suggests that combined therapy of insulin glargine and glimepiride should be considered for T2DM patients who have unsatisfactory response to previous OAD treatment.