Aims: To assess the effectiveness of insulin glargine 300 ui/ml (Gla-300) compared with insulin glargine 100 ui/ml (Gla-100) on reducing nocturnal hypoglycemia and improving glycemic control in type 1 and type 2 diabetes patients.
Methods: We systematically searched in Medline, Embase, Web of Science, and Cochrane Central Register of Controlled Trials until July 4th, 2018. This study was registered with PROSPERO (CRD42017080134). We included randomized clinical trials comparing Gla-300 versus Gla-100 reporting the rate ratio or number of events of nocturnal hypoglycemia and HbA1c levels percentage or mmol/mol-1. The main outcome was the incidence rate ratio (RR) of nocturnal hypoglycemia events. The heterogeneity of results across studies was assessed using the I2 statistic. Fixed- and random-effect models were used to estimate pooled RRs.
Results: Nine studies were included in the meta-analysis, including 3977 adult patients. Compared with Gla-100, the use of Gla-300 reduced confirmed nocturnal hypoglycemia [RR = 0.81 (0.69, 0.95)] and clinically significant nocturnal hypoglycemia [RR = 0.75 (0.63, 0.91)]. Reductions in clinically significant nocturnal hypoglycemia events [RR = 0.64 (0.42, 0.97)] in type 1 diabetes patients were found. A small decrease in HbA1c levels in favor of Gla-300 in the pooled sample was identified [ES = - 0.08 (95% CI - 0.14, - 0.01)].
Conclusions: The best current evidence indicates that Gla-300 reduces the incidence of nocturnal hypoglycemia with slight improvements in glycemic control compared with Gla-100 in both type 1 and type 2 diabetes adult patients.
Keywords: HbA1c; meta-analysis; Hypoglycemia; Insulin glargine; Type 1 diabetes; Type 2 diabetes.