Comparison of morning basal + 1 bolus insulin therapy (insulin glulisine + insulin glargine 300 U/mL vs insulin lispro + insulin glargine biosimilar) using continuous glucose monitoring: A randomized crossover study

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Abstract

Introduction

We compared the effects of morning administration of insulin glulisine + insulin glargine 300 U/mL (G + G300) with that of insulin lispro + insulin glargine biosimilar (L + GB).

Materials and Methods

A total of 30 patients with type 2 diabetes who wore a continuous glucose monitoring device on admission after glucose levels were stabilized by morning long-acting and ultra-rapid-acting insulins were randomly allocated to groups who received G + G300 on days 1 and 2, and the same dose L + GB on days 3 and 4, or vice versa. Data collected on days 2 and 4 (mean amplitude of glycemic excursion, mean of daily differences: all days) were analyzed. Insulin was injected at 08.00 h. A day was defined as the period from 08.00 h one day, to 08.00 h the next day. Test meals were given.

Results

Increased post-breakfast glucose level, post-breakfast glucose gradient, mean glucose level, standard deviation and M-value (24 h, 00.00–06.00 h), mean amplitude of glycemic excursion, and mean of daily differences were significantly lower in patients taking G + G300 than those taking L + GB (P ≤ 0.0001–0.04). The area over the glucose curve (<70 mg/dL) was not significantly different between groups. Pre-lunch − pre-breakfast glucose levels were significantly lower in patients taking L + GB than those taking G + G300 (P < 0.0001). The difference in the highest post-breakfast glucose level between groups (Δ = G + G300 − L + GB) was significantly correlated to 24-h mean glucose level (r = 0.40, P = 0.03).

Conclusions

Compared with L + GB, G + G300 decreases post-breakfast glucose level reducing rate of rise of that, nocturnal and 24-h glucose variability and level without causing hypoglycemia, and daily variance.

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