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.
- Author:
Yu-fang BI
1
;
Lie-bin ZHAO
;
Xiao-ying LI
;
Wei-qing WANG
;
Shou-yue SUN
;
Yu-hong CHEN
;
Jie HONG
;
Ting-wei SU
;
Jian-min LIU
;
Guang NING
Author Information
- Publication Type:Journal Article
- MeSH: Adult; Aged; Blood Glucose; analysis; Cross-Over Studies; Diabetes Mellitus, Type 1; drug therapy; Diabetes Mellitus, Type 2; drug therapy; Female; Humans; Hypoglycemic Agents; administration & dosage; Insulin; administration & dosage; analogs & derivatives; Insulin Aspart; Insulin Infusion Systems; Male; Middle Aged
- From: Chinese Medical Journal 2007;120(19):1700-1703
- CountryChina
- Language:English
-
Abstract:
BACKGROUNDSubcutaneous 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.
METHODSA 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 (10 pm), midnight (2 am) every day during the treatment.
RESULTSThe 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.
CONCLUSIONInsulin Aspart results in better control of blood glucose levels than regular human insulin (Novolin R) in diabetic patients during delivery by CSII.