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

ObjectiveThis study investigated the effect of insulin glargine (LANTUS®) 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 methodsIn 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®).ResultsBaseline characteristics were similar between the two groups. HbA1c 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.ConclusionThese results confirm earlier reports that insulin glargine provides superior glycemic control with less hypoglycemia and demonstrates that these benefits are consistent between different ethnicities.