| ObjectivesTo compare effects of mixed protamine zinc recombinant human insulin lispro injection 50R(Humalog Mix 50)with insulin aspart 30 injection(Novo Mix 30)on glycemic variations in patients with type 2 diabetes mellitus(T2DM).MethodsThe recruited patients were treated with continuous subcutaneous insulin infusion(CSII)therapy for achieving euglycemic control.Patients were then treated with either Humalog Mix 50 or Novo Mix 30 thrice-daily therapy for another 2-day,then subjects were received 4-day cross-over treatment.Continuous glucose monitoring(CGM)was performed in all subjects for at least 96 hours during the cross-over study period.The 24-hour mean blood glucose(24 h MBG),the mean amplitude of glycemic excursions(MAGE),and the incremental area under curve(AUC)of glucose concentrations above 10.0 mmol/L or less than 3.9 mmol/L were analyzed.Results1.A total of 101 patients(51.49%male,48.51%female)with T2DM were enrolled this study.The patients with age was 59.44 ± 11.82 years,the duration of disease was 6.53±6.22 years,body mass index(BMI)was 23.02±7.30 kg/m2,waist circumference was 87.66 ± 8.53 cm,waist to hip ratio was 0.94 ± 0.05,systolic pressure was 134.51±19.61 mmHg,diastolic pressure was 81.79±11.58 mmHg,and heart rate was 77.69±15.24 bmp.2.The laboratory indexes of the enrolled T2DM patients as follows:HbAic:9.82±2.61%,fasting C Peptide:2.04±0.98 ng/mL,120 minutes C peptide:4.98 ± 2.82 ng/mL,Mastuda Index:499.00± 97.83,HOMA-IR:11.17±3.02,HOMA-?:109.81±21.04.3.Dosage of insulin used for patients:1)CSII treatment period:total insulin:114.80±42.28 IU/Day,basal insulin:64.80±21.04 IU/Day,bolus insulin:50.00±21.24 IU/Day;2)Insulin titrated period:total insulin:76.08±29.20 IU/Day;3 Cross study period:total insulin:112.00±41.07 IU/Day,Pre-breakfast insulin:46.00±16.44 IU/Day,Pre-lunch insulin:36.00 ± 11.05 IU/Day,Pre-dinner insulin:36.00 ± 13.58 IU/Day.4.The blood glucose fluctuation parameters between groups(Humalog Mix 50 VS.Novo Mix 30)were as follows:24 h MBG(7.95±2.92 VS.8.07± 2.70 mmol/L,P=0.77);SDBG(1.99±0.90 VS.2.09±0.86 mmol/L,P=0.42);MAGE(4.93 ± 2.76 VS.5.16±2.15 mmol/L,P=0.51);the incremental AUC of hyperglycemia(>10.0 mmol/L)(0.65 ± 0.95 VS.0.55 ±0.66 mmol/L/Day,P=0.37);the incremental AUC of hypoglycemia(<3.9 mmol/L)(0.01±0.04 VS.0.00 ± 0.02 mmol/L/Day,P =0.22);the time spent in hyperglycemia(>10.0 mmol/L)(26.23 ± 24.16 VS.23.79±21.60%,P = 0.45);the percentage time duration(%)of hypoglycemia(<3.9 mmol/L)(1.59±3.97 VS.1.07±3.31%,P = 0.31).5.Stratified analysis:1)The MAGE were significant lower in Humalog 50 groups than that in NovoMix 30 groups(4.52±2.50 VS.5.53±1.90 mmol/L,P=0.02)either in male patients(3.65±2.19 VS.5.95 ± 1.68 mmol/L,P = 0.02]or in age young onset of onset patients(<40 years);2)Younger(<60 years)patients achieved significant lower 24 h MBG than those of older patients(? 60 years)(8.78 ± 2.63 VS.7.13±2.97 mmol/L,P = 0.00)during Humalog 50 therapy,and patients with short course of disease(<7 years)also had lower 24 h MBG than those of patients with longer course of disease(? 7 years)(8.64 ± 2.77 VS.7.43 ± 2.94 mmol/L,P=0.04);3)Younger patients experienced significant short percentage time duration(%)of hyperglycemia(>10.0 mmol/L)compared with older patients(28.20 ? 23.69 VS.19.47 ± 18.58%,P = 0.04)treated with NovoMix 30;patients with lower BMI(<25 kg/m2)had significant lower the incremental AUC of hyperglycemia than that patients with high BMI(? 25 kg/m2)(0.38 ±0.42 VS.0.65±0.78 mmol/L/Day,P=0.03);the incremental AUC of hypoglycemia(<3.9 mmol/L)in male patients was significantly higher than that of female(0.01 ± 0.03 VS.0.00 ±0.00 mmol/L/Day,P=0.00);the percentage time duration(%)of hypoglycemia(<3.9 mmol/L)in patients with short course of disease was less than that of patients with long course of disease(0.23±0.81 VS.1.69±4.22%,P=0.01);the MAGE in patients with normal pressure was significantly lowered than those of patients with hypertension(4.77±2.16 VS.5.65±2.06 mmol/L,P=0.04).Conclusions1,The Mid-or Low-mixed insulin analogues both had the ability to control glycemic fluctuations in T2DM patients.2,The MAGE in male patients or young onset patients was significantly smoothed treated with Humalog Mix 50 compared with Novo Mix 30 therapy.3,The 24 h MBG were better controlled in patients with either younger age or shorter course of disease with Humalog Mix 50 therapy. |
PDF Full Text Request