A Study Of The Effects Of Different Low-premix Insulin Analogs Or Different Injection Times On Blood Glucose Profiles In Patients With Newly Diagnosed Type 2 Diabetes Mellitus

Part I Efficacy Comparison of Prandilin 25 and Humalog Mix 25 in Patients with Newly Diagnosed Type 2 Diabetes by a Continuous Glucose Monitoring SystemObjective:To determine the clinical efficacy of insulin lispro 75/25-Prandilin 25 vs insulin lispro 25-Humalog mix 25 in treatment of newly diagnosed type 2 diabetes mellitus(T2DM)by continuous glucose monitoring system(CGMS).Methods : This was a single center,randomized,case-crossover clinical trial.Participants were randomly allocated to two groups and underwent two kinds of insulin lispro 75/25 treatment separated by one day washout period.In total,eighty one patients with newly diagnosed T2 DM with hemoglobin A1c(Hb A1c)above 9%were hospitalized and randomly divided to receive Prandilin 25/Humalog mix 25 or Humalog mix25/Prandilin 25 treatment.All Participants were subjected to metformin therapy simultaneously.Glycaemic control was reached after 7-8 d Prandilin 25 or Humalog mix 25 treatment,each patient received CGMS for 5 consecutive days(from day 1 to day 5).On day 3 of CGMS performance,Prandilin 25 treatment was switched to Humalog mix 25 treatment in same dosage or vice versa.Parameters re Presenting glucose viability and Postprandial glucose excursions,including 24 h mean blood glucose(24h MBG),24 h standard deviation of blood glucose(24h SDBG),24 h mean amplitude of glycemic excursion(24h MAGE),large amplitude of glycemic excursion(LAGE),incremental area under the curve(AUC)for different glucose levels,and postmeal relative areas under the CGMS curve(AUCPP)for 1-4h of each meal,were calculated for each patient.Results : No significant differences were found in the 24 h MAGE,24 h MBG,24 h SDBG,LAGE,mean 1h preprandial blood glucose and the incidence of hypoglycemia between Prandilin 25 treatment group and Humalog mix 25 treatment group.Similarly,there were no between-treatment differences for AUC and time when blood glucose was below 3.9 mmol/L,between 3.9 mmol/L and 10.0 mmol/L,or above 10.0 mmol/L.Further analysis showed AUCPP for 1-4h of each meal for two kinds of treatments were similar.However,the mean estimated cost of Prandilin25 was only 85% of Humalog mix25 in one treatment course.Conclusion:Prandilin 25 is non-inferior in clinical efficacy compared with Humalog mix 25.In view of the significant difference in the cost of two kinds of insulin lispro25,Prandilin 25 would be a much more cost-effective anti-diabetes drug for management of T2 DM.Part II Efficacy Comparison of Preprandial and Postprandial Prandilin 25 Administration in Patients with Newly Diagnosed Type 2 Diabetes Using a Continuous Glucose Monitoring SystemObjective: 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 T2 DM patients with hemoglobin A1c> 8.0% were hospitalized and received Prandilin25 plus metformin treatment.Glycemic control was reached after a7-to-8-day run-in period.Patients underwent 4 days of treatment consisting of preprandial Prandilin 25 on day 1 and postprandial Prandilin 25 on day 3 at the same dosage.The primary outcome was the 24-h mean amplitude of glycemic excursion(24h MAGE).Secondary outcomes were other daily glycemic variability parameters,including 24-h mean blood glucose(24h MBG),24-h standard deviation of blood glucose(24h SDBG),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 24 h MAGE,24 h MBG,24 h SDBG 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 3.9mmol/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 10.0mmol/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 1–4h after each meal,as well as the incidence of hypoglycemia,were similar for the Preprandial and Postprandial Prandilin 25 groups.Conclusion: In patients with T2 DM 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.