Insulin glargine versus NPH insulin therapy in Asian Type 2 diabetes patients

Objective: This study investigated the effect of insulin glargine (LANTUS((R))) versus NPH insulin on metabolic control and safety in Asian patients with Type 2 diabetes, inadequately controlled on oral hypoglycemic agents (OHAs). Study design and methods: In this open-label, randomized, parallel, multinational, 24-week, non-inferiority study, 443 patients received either once-daily insulin glargine (n = 220) or NPH insulin (n = 223) at bedtime, plus glimepiride (Amaryl((R))). Results: Baseline characteristics were similar between the two groups. HbA(1c), levels decreased in the insulin glargine and NPH groups over the study period in the per-protocol (PP; -1.10% versus 0.92%) and full-analysis (FA; -0.99% versus -0.77%) populations. In the PP population, the difference between adjusted means (predefined equivalence region >-0.4%) was 0.19% (90% confidence interval [CI]: 0.02, 0.36), demonstrating non-inferiority between the two treatments. In a superiority analysis (FA population), the difference between adjusted mean changes in the two groups was 0.22% (95% CI: 0.02, 0.42), demonstrating the superiority of insulin glargine (p = 0.0319). Moreover, the number of hypoglycemic episodes was significantly lower with insulin glargine versus NPH insulin (p < 0.004), particularly severe (p < 0.03) and nocturnal (p < 0.001). Daily insulin dose increased from 9.6 +/- 1.5 to 32.1 +/- 17.6 U in the insulin glargine group and from 9.8 +/- 1.9 to 32.8 +/- 18.9 U in the NPH insulin group. Conclusion: These results confirm earlier reports that insulin glargine provides superior glycemic control with less hypoglycemia and demonstrates that these benefits are consistent between different ethnicities. (c) 2006 Elsevier Ireland Ltd. All rights reserved.