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)>or=140 mg/dL] on oral antidiabetic drugs (OADs) were enrolled. Patients were treated once daily with glimepiride 3mg (morning) and glargine (bedtime) with dose titration to achieve FPG 72-100mg/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 (88.3mg/dL) (p<0.0001), mean PPG (112.0mg/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.