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.
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
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 (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.


CONCLUSIONS
Insulin Aspart results in better control of blood glucose levels than regular human insulin (Novolin R) in diabetic patients during delivery by CSII.
Bi
Yu-fang
YF
Shanghai Clinical Center for Endocrine and Metabolic Diseases, Shanghai Institute of Endocrinology and Metabolism, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China.
Zhao
Lie-bin
LB
Li
Xiao-ying
XY
Wang
Wei-qing
WQ
Sun
Shou-yue
SY
Chen
Yu-hong
YH
Hong
Jie
J
Su
Ting-wei
TW
Liu
Jian-min
JM
Ning
Guang
G
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D061267:Insulin Aspart; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart