Abstract
INTRODUCTION: The aim of this study was to determine the clinical efficacy of preprandial and postprandial Prandilin 25 (premixed insulin lispro 25) administration in patients with newly diagnosed type 2 diabetes mellitus (T2DM) using a continuous glucose monitoring (CGM) system. METHODS: This was a single-center, self-controlled comparative clinical trial. Newly diagnosed T2DM patients with hemoglobin A1c > 8.0% were hospitalized and received Prandilin 25 plus metformin treatment. Glycemic control was reached after a 7-to-8-day run-in period. Patients underwent 2 days of treatment consisting of preprandial Prandilin 25 on day 1 and postprandial Prandilin 25 on day 2 at the same dosage. The primary outcome was the 24-h mean amplitude of glycemic excursion (24 hMAGE); secondary outcomes were other daily glycemic variability parameters, including 24-h mean blood glucose (24hMBG), 24-h standard deviation of blood glucose (24hSDBG), large amplitude of glycemic excursion (LAGE), incremental area under the curve (AUC) values for different glucose levels, postprandial glucose excursion, and incidence of hypoglycemia, which were assessed using a CGM system. RESULTS: Eighty-five patients completed this study. There was no statistically significant difference in 24hMAGE, 24hMBG, 24hSDBG, or LAGE between the preprandial injection group and the postprandial injection group. Similarly, there was no between-treatment difference in the AUC for a blood glucose level below 3.9 mmol/L, in the AUC for a blood glucose level above 10.0 mmol/L, or in the percentages of time that the blood glucose level was below 3.9 mmol/L or above 10.0 mmol/L. Further analysis showed that the pre-meal glucose, peak height, and time to peak after each meal, the relative areas under the CGM curve at 1-4 h after each meal, as well as the incidence of hypoglycemia, were similar for the preprandial and postprandial Prandilin 25 groups. CONCLUSION: In patients with T2DM managed with premixed insulin lispro 25, postprandial injection (within 30 min of meal onset) may be an acceptable alternative to preprandial injection when the regular preprandial insulin dose is omitted. TRIAL REGISTRATION: Chinese Clinical Trial Register identifier: ChiCTR1800015828.