Insulin glargine versus NPH insulin therapy in AsianType 2 diabetes patients

Objective:

This study investigated the effect of insulin glargine (LANTUS1) versus NPH insulin on metabolic control and safety inAsian 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 patientsreceived either once-daily insulin glargine (n = 220) or NPH insulin (n = 223) at bedtime, plus glimepiride (Amaryl1).

Results:

Baseline characteristics were similar between the two groups. HbA1c levels decreased in the insulin glargine and NPHgroups 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 (FApopulation), the difference between adjusted mean changes in the two groups was 0.22% (95% CI: 0.02, 0.42), demonstrating thesuperiority of insulin glargine ( p = 0.0319). Moreover, the number of hypoglycemic episodes was significantly lower with insulinglargine versus NPH insulin ( p < 0.004), particularly severe ( p < 0.03) and nocturnal ( p < 0.001). Daily insulin dose increasedfrom 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 hypoglycemiaand demonstrates that these benefits are consistent between different ethnicities.