OBJECTIVE: This 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 METHODS: In this open-label, randomized, parallel, multinational, 24-week, non-inferiority study, 443 patients received eitheronce-daily insulin glargine (n=220) or NPH insulin (n=223) at bedtime, plus glimepiride (Amaryl). 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.
RCT Entities:
OBJECTIVE: This study investigated the effect of insulinglargine (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 METHODS: In this open-label, randomized, parallel, multinational, 24-week, non-inferiority study, 443 patients received either once-daily insulinglargine (n=220) or NPH insulin (n=223) at bedtime, plus glimepiride (Amaryl). RESULTS: Baseline characteristics were similar between the two groups. HbA(1c) levels decreased in the insulinglargine 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 insulinglargine (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 insulinglargine 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 insulinglargine provides superior glycemic control with less hypoglycemia and demonstrates that these benefits are consistent between different ethnicities.
Authors: Rimke C Vos; Mariëlle Jp van Avendonk; Hanneke Jansen; Alexander N Goudswaard; Maureen van den Donk; Kees Gorter; Anneloes Kerssen; Guy Ehm Rutten Journal: Cochrane Database Syst Rev Date: 2016-09-18
Authors: Kees J Gorter; Floris Alexander van de Laar; Paul G H Janssen; Sebastian T Houweling; Guy E H M Rutten Journal: BMJ Clin Evid Date: 2012-10-11