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Objective:To compare the efficacy and safety of biphasic insulin aspart 30(BIAsp30) once daily with Glargine once daily on the basis of oral administration metformin and glimepiride in patients with type 2 diabetes mellitus(T2DM).Methods:18 subjects with T2DM, including 11 men and 7 women, were enrolled. Metformin(1500mg/d) and glimepiride (4 mg/d)were given to all patients before and during insulin therapy. After the run-in period, the subjects were randomized to a 12-week treatment with either BIAsp30 or Glargine. 9 cases for BIAsp30 group (55.22±7.5 years old), including 5 men and 4 women and 9 cases for Glargine group (58.22±9 years old), including 6 men and 3 women. The dosages of biphasic insulin aspart 30 or glargine were adjusted according to the fasting blood glucose. Fasting blood glucose (FBG), glycosylated haemoglobin (HbAlc) and self-recorded daily nine-point blood glucose (BG) were measured and compared in two groups. The dosages of BIasp 30 and Glargine, hypoglycaemic events and weight were recorded and compared in two groups.Results:1. BIAsp30 group FBG pretreatment was 9.79 mmol/L, treatment was 6.43 mmol/L; Glargine group FBG pretreatment was 10.39 mmol/L, treatment was 6.39 mmol/L. BIAsp30 group HbAlc pretreatment was 8.58%, treatment was 7.66%; Glargine group HbAlc pretreatment was 8.46%, treatment was 7.76% .Both BIAsp30 and Glargine group reduced FBG and HbAlc. But the reduction of FBG and HbAlc was not significantly different between BIAsp30 and Glargine (P>0.05).2. BIAsp30 group nine-point BG pretreatment were FBG 9.40 mmol/L, 2h postprandial blood glucose (2hPBG) of breakfast 13.37 mmol/L, preprandial blood glucose of lunch 9.99 mmol/L, 2hPBG of lunch 12.20 mmol/L,preprandial blood glucose of supper 9.47 mmol/L, 2hPBG of supper 12.22 mmol/L,BG of bedtime 11.73 mmol/L,BG of night 9.47 mmol/L, FBG of next day 9.24 mmol/L;after treatment were FBG 7.33 mmol/L, 2hPBG of breakfast 10.66 mmol/L,preprandial blood glucose of lunch 8.48 mmol/L,2hPBG of lunch 12.13 mmol/L, preprandial blood glucose of supper 9.54 mmol/L, 2hPBG of supper 8.98 mmol/L, BG of bedtime 8.20 mmol/L,BG of night 6.80 mmol/L, FBG of next day 6.43 mmol/L. Glargine group nine-point BG pretreatment were FBG 8.50 mmol/L, 2hPBG of breakfast 10.69 mmol/L,preprandial blood glucose of lunch 6.89 mmol/L, PBG of lunch 12.61 mmol/L, preprandial blood glucose of supper 8.72 mmol/L, 2hPBG of supper 12.58 mmol/L, BG of bedtime 11.34 mmol/L,BG of night 8.14 mmol/L, FBG of next day 8.11 mmol/L;after treatment were FBG 6.27 mmol/L, 2hPBG of breakfast 12.28 mmol/L, preprandial blood glucose of lunch 7.72 mmol/L,2hPBG of lunch 9.48 mmol/L, preprandial blood glucose of supper 6.48 mmol/L, 2hPBG of supper 11.38 mmol/L,BG of bedtime10.13 mmol/L,BG of night 6.90 mmol/L,FBG of next day 6.39 mmol/L.Compared with pretreatment, at the end of 12 weeks treatment, all blood glucose at the nine-point were decreased significantly in both BIAsp30 group and Glargine group (P<0.05). The 2hPBG of breakfast and supper and bedtime in BIAsp30 group were less than those in Glargine group (P<0.05). Preprandial blood glucose of supper in glargine was less than that in BIAsp30(P<0.05).3. It showed that the dosage in BIAsp30 was 23.11u/d, in Glargine was 16.67u/d, the dosage in BIAsp30 more than that in Glargine, but there was no significant difference between them (P>0.05).4. In BIAsp30 group no hypoglycemia in patients,in Glargine group only one patient has hypoglycemia, the rate of hypoglycemia was 5.56%, BIAsp30 did not increase the frequence of hypoglycemia compared to Glargine (P>0.05).Conclusions:BIAsp30 and Glargine have similar efficacy and safty profiles in the treatment of type 2 diabetic patients. Both regimes are well tolerated. BIAsp30 improves postprandial glycemic control compared to Glargine in patients with T2DM. BIAsp30 did not increase the risk of hypoglycemia compared to Glargine. Galrgine can control basal glucose better.
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