Long-term glycaemic control with insulin glargine in Type 2 diabetes

Objective: This study examined the long-term glycaemic control and safety of insulin glargine (LANTUS (R)) in patients with Type 2 diabetes. Study design and methods: This <= 28-month, long-term extension of a multinational, multicentre, open-label 52-week study enrolled patients from the original study to continue taking insulin glargine at bedtime plus previous oral hypoglycaemic agents (OHAs). Efficacy and safety were assessed by HbA(1c) and adverse events, symptomatic hypoglycaemia and selected clinical and laboratory variables. Results: Two hundred and thirty-nine treated patients from the original study entered the extension study and 198 completed the extension study. There was a 1.02% reduction in mean HbA(1c) from baseline of the original study (9.44%) to endpoint of the extension study (8.42%). No new or unexpected adverse events were observed with longer term exposure to insulin glargine over a treatment period of <= 39 months. Treatment-emergent adverse events were reported for 152 patients (63.6%), four of which (1.7%) were considered to be possibly treatment-related. Mean weight gain observed during the original study was +2.12 kg with an absence of further weight gain at the end of the extension study (+2.02 kg). Conclusion: Long-term insulin glargine treatment plus OHAs provides continued glycaemic control and is well tolerated in patients with Type 2 diabetes. Therefore, insulin glargine appears to be suitable for the long-term management of Type 2 diabetes. (c) 2005 Elsevier Ireland Ltd. All rights reserved.