A 2-way cross-over,open-labeled trial to compare efficacy and safety of insulin Aspart and Novolin R

来源 :Chinese Medical Journal | 被引量 : 0次 | 上传用户:rdx200901as
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Background Subcutaneous absorption is accelerated by the monomeric conformation of insulin Aspart,which providesgood glycemic control with a lower risk of hypoglycemia and less body weight increase.In the present study weinvestigated the efficacy and safety of a rapid-acting human insulin analogue (insulin Aspart) delivered with continuoussubcutaneous insulin infusion (CSII) into Chinese diabetic patients.Methods A total of 21 patients with type 1 or type 2 diabetes were recruited for the 2-way cross-over,open-labeled trial,and then randomized to Group A (n=10,treated with insulin Aspart) or Group B (n=11,treated with Novolin R).InsulinAspart and Novolin R were administered by CSII.Capillary glucose concentrations were measured at 8 time points,pre-prandial and postprandial,bedtime (10 pm),midnight (2 am) every day during the treatment.Results The average capillary glucose profiles for the day were much better controlled in Group A than in Group B(P<0.01).The blood glucose levels were particularly better controlled in Group A than in Group B at pre-breakfast((6.72±1.24) mmol/L vs (7.84±1.58) mmol/L,P=0.014),post-breakfast ((8.96±2.41) mmol/L vs (11.70±3.11) mmol/L,P=0.0028),post-supper ((8.15±2.10) mmol/L vs (10.07±2.36) mmol/L,P=0.008),bed time ((7.73±1.72) mmol/L vs(9.39±2.05) mmol/L,P=0.007) and midnight ((6.32±1.16) mmol/L vs (7.48±1.36) mmol/L,P=0.0049).There was nosignificant difference in the frequency of hypoglycemic episodes between the two groups.Conclusion Insulin Aspart results in better control of blood glucose levels than regular human insulin (Novolin R) indiabetic patients during delivery by CSII.Chin Med J 2007;120(19):1700-1703 Background Subcutaneous absorption is accelerated by the monomeric conformation of insulin Aspart, which providesgood glycemic control with a lower risk of hypoglycemia and less body weight increase.In the present study weinvestigated the efficacy and safety of a rapid-acting human insulin analogue (insulin Aspart) delivered with continuoussubcutaneous insulin infusion (CSII) into Chinese diabetic patients. Methods A total of 21 patients with type 1 or type 2 diabetes were recruited for the 2-way cross-over, open-labeled trial, and then randomized to Group A (n = 10, treated with insulin Aspart) or Group B (n = 11, treated with Novolin R) .Insulin Aspart and Novolin R were administered by CSII. Capillary glucose concentrations were measured at 8 time points, pre-prandial and postprandial, bedtime Results: The average capillary glucose profiles for the day were much better controlled in Group A than in Group B (P <0.01). The blood glucose levels were particularly better controlled in Group A than in Group B at pre-breakfast ((6.72 ± 1.24) mmol / L vs (7.84 ± 1.58) mmol / L, P = 0.014) (P <0.001), post-supper (8.15 ± 2.10) mmol / L vs (10.07 ± 2.36) mmol / L, P = 0.008) (6.32 ± 1.16) mmol / L vs (7.48 ± 1.36) mmol / L, P = 0.0049). Where was nosignificant difference in the frequency of hypoglycemic episodes between the two groups. Conclusions Insulin Aspart results in better control of blood glucose levels than regular human insulin (Novolin R) indiabetic patients during delivery by CSII. Chin Med J 2007; 120 (19): 1700-1703
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