Glycaemic efficacy and safety of mealtime faster-acting insulin aspart administered by injection as compared to insulin aspart in people with diabetes mellitus: A meta-analysis of randomized controlled trials.

To summarize all relevant randomized controlled trials (RCTs) and provide precise effect estimates of glycaemic efficacy/safety of faster-acting insulin aspart administered by injection as compared to insulin aspart in people with diabetes mellitus. PubMed/Cochrane Library were systematically searched till October 10, 2020, to identify RCTs with duration ≥16 weeks, evaluating efficacy/safety of mealtime injections of faster aspart compared to insulin aspart in people with type 1 diabetes mellitus and type 2 diabetes mellitus. Studies using faster aspart as continuous subcutaneous insulin infusion were excluded. Continuous and dichotomous outcome variables (expressed as estimated treatment difference and rate ratio in RCTs, respectively) were pooled using generic inverse variance method with fixed/random-effects model. For each outcome variable, subgroup analysis between type 1 diabetes mellitus and type 2 diabetes mellitus was performed. We included five RCTs; three of type 1 diabetes mellitus (n = 1963) and two of type 2 diabetes mellitus (n = 1780). All had low risk of bias. Faster aspart was associated with small but significant improvement in HbA1c than insulin aspart (MD: -0.06%, 95% CI: -0.10, -0.02, p = 0.005, I2  = 19%). HbA1c reduction was statistically significant only in type 1 diabetes mellitus on subgroup analysis (MD: -0.08%, 95% CI: -0.14, -0.02, p = 0.005, I2  = 47%). Besides, faster aspart was associated with reduced postprandial plasma glucose (PPG) increment at 1 h/2 h after meal test and increased 1,5-anhydroglucitol compared to insulin aspart. Early postprandial hypoglycaemic episodes were higher with faster aspart; however, overall and nocturnal hypoglycaemic episodes were not different from insulin aspart. Faster aspart is associated with reduced HbA1c , PPG increment and comparable overall hypoglycaemic episodes with regard to insulin aspart.