The effect of glargine versus glimepiride on pancreatic β-cell function in patients with type 2 diabetes uncontrolled on metformin monotherapy: open-label, randomized, controlled study.

Abstract

The aim of present study is to assess whether if basal insulin, glargine, could

improve insulin secretory function of beta-cells compared with glimepiride when

metformin alone was failed. This was an open-label and multi-center study for 52

weeks in Korean patients with uncontrolled type 2 diabetes by metformin

monotherapy. Subjects were randomized to glargine or glimepiride groups (n = 38

vs. 36, respectively). The primary endpoint was to compare changes in c-peptide

via glucagon test after 48 weeks. Glycemic efficacy and safety endpoints

(glycated hemoglobin (HbA1c), HOMA-B, fasting plasma glucose (FPG), lipid

profiles, and hypoglycemic events) were also checked. The mean disease duration

of all subjects was 88.2 months. Changes in C-peptide was no significant

different between groups (P = 0.73), even though insulin secretion was not

worsened in both groups at the endpoint. Glargine was not superior to glimepiride

in other beta-cell function indexes such as HOMA-B (P = 0.28). HbA1c and FPG

reduced significantly in each groups but not different between two groups.

Although, severe hypoglycemia did not occur, symptomatic hypoglycemia was more

frequent in glimepiride group (P = 0.01). Insulin glargine was as effective as

glimepiride in controlling hyperglycemia and maintaining beta-cell function in

Korean patients with type 2 diabetes during 48 weeks study period, after failure

of metformin monotherapy. Hypoglycemic profile was favorable in the insulin

glargine group and less weight gain was observed in the glimepiride group. Our

results suggest that glargine and glimepiride can be considered after failure of

metformin monotherapy.