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A 2-way cross-over, open-labeled trial to compare efficacy and safety of insulin Aspart and Novolin R delivered with CSII in 21 Chinese diabetic patients

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Author:
No author available
Journal Title:
CHINESE MEDICAL JOURNAL
Issue:
19
DOI:
No doi available
Key Word:
rapid-acting insulin analogue;diabetes mellitus;continuous subcutaneous insulin infusion;capillary glucose

Abstract: Background Subcutaneous absorption is accelerated by the monomeric conformation of insulin Aspart, which provides good glycemic control with a lower risk of hypoglycemia and less body weight increase. In the present study we investigated the efficacy and safety of a rapid-acting human insulin analogue (insulin Aspart) delivered with continuous subcutaneous insulin infusion (CSII) into Chinese diabetic patients.Methods Atotal 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 (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 no significant 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) in diabetic patients during delivery by CSII.

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