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Insulin aspart vs. human insulin in the management of long‐term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial
Author(s) -
Home P. D.,
Lindholm A.,
Riis A.
Publication year - 2000
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1046/j.1464-5491.2000.00380.x
Subject(s) - medicine , insulin aspart , insulin , diabetes mellitus , endocrinology , type 2 diabetes , type 2 diabetes mellitus , randomized controlled trial , type 1 diabetes , basal (medicine) , hypoglycemia
SUMMARYAims To compare the efficacy of insulin aspart, a rapid‐acting insulin analogue, with that of unmodified human insulin on long‐term blood glucose control in Type 1 diabetes mellitus. Methods Prospective, multi‐centre, randomized, open‐labelled, parallel‐group trial lasting 6 months in 88 centres in eight European countries and including 1070 adult subjects with Type 1 diabetes. Study patients were randomized 2:1 to insulin aspart or unmodified human insulin before main meals, with NPH‐insulin as basal insulin. Main outcome measures were blood glucose control as assessed by HbA 1c , eight‐point self‐monitored blood glucose profiles, insulin dose, quality of life, hypoglycaemia, and adverse events. Results After 6 months, insulin aspart was superior to human insulin with respect to HbA 1c with a baseline‐adjusted difference in HbA 1c of 0.12 (95% confidence interval 0.03–0.22) %Hb, P < 0.02. Eight‐point blood glucose profiles showed lower post‐prandial glucose levels (mean baseline‐adjusted −0.6 to −1.2 mmol/l, P < 0.01) after all main meals, but higher pre‐prandial glucose levels before breakfast and dinner (0.7–0.8 mmol/l, P < 0.01) with insulin aspart. Satisfaction with treatment was significantly better in patients treated with insulin aspart (WHO Diabetes Treatment Satisfaction Questionnaire (DTSQ) baseline‐adjusted difference 2.3 (1.2–3.3) points, P < 0.001). The relative risk of experiencing a major hypoglycaemic episode with insulin aspart compared to human insulin was 0.83 (0.59–1.18, NS). Major night hypoglycaemic events requiring parenteral treatment were less with insulin aspart (1.3 vs. 3.4% of patients, P < 0.05), as were late post‐prandial (4–6 h) events (1.8 vs. 5.0% of patients, P < 0.005). Conclusions These results show small but useful advantage for the rapid‐acting insulin analogue insulin aspart as a tool to improve long‐term blood glucose control, hypoglycaemia, and quality of life, in people with Type 1 diabetes mellitus.