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Using Continuous Glucose Monitoring to Measure the Frequency of Low Glucose Values When Using Biphasic Insulin Aspart 30 Compared With Biphasic Human Insulin 30

A double-blind crossover study in individuals with type 2 diabetes

¹ Leicester Royal Infirmary NHS Trust, Leicester, U.K.
² Bolton Diabetes Centre, Bolton PCT/Bolton Hospitals NHS Trust, Bolton, U.K.
³ Division of Medicine and Therapeutics, Ninewells Hospital, Dundee, Scotland, U.K.
⁴ Wilkinson Associates, Radnage, Bucks, U.K.
⁵ Novo Nordisk, Broadfield Park, Crawley, West Sussex, U.K.
⁶ Academic Unit of Diabetes, Endocrinology, and Metabolism, School of Medicine and Biomedical Sciences, Sheffield, U.K.

Address correspondence and reprint requests to Prof. Simon Heller, Professor of Clinical Diabetes, Academic Unit of Diabetes, Endocrinology and Metabolism, Room OU141, School of Medicine and Biomedical Sciences, Beech Hill Road, Sheffield S10 2RX, U.K. E-mail: s.heller{at}sheffield.ac.uk

OBJECTIVE—Rapid-acting insulin analogs in basal-bolus regimens can reduce nocturnal hypoglycemia, so it is conceivable that twice-daily biphasic insulin analogs might reduce hypoglycemia in patients with insulin-treated type 2 diabetes. We used a continuous glucose monitoring system (CGMS) and self-reported episodes to investigate differences in the frequency of low glucose values in patients with type 2 diabetes, using either biphasic insulin aspart 30 (BIAsp 30) or biphasic human insulin 30 (BHI 30).

RESEARCH DESIGN AND METHODS—This was a double-blind, two-period, crossover trial involving 160 subjects. After 8 weeks’ run-in, subjects were randomized to the first of two 16-week treatment periods.

RESULTS—No differences in overall incidence of low interstitial glucose (IG) were found. Twenty-four–hour plots of CGMS showed low IG was more frequent at night than during the day and was unrecognized by patients. At night, subjects spent significantly less time (percentage of total CGMS recorded) with IG <3.5 and <2.5 mmol/l during BIAsp 30 than during BHI 30 treatment, respectively (<3.5 mmol/l: 6.36 vs. 7.93% [mean], 0.67 vs. 2.43% [median], P = 0.018; <2.5 mmol/l: 2.35 vs. 2.86% [mean], 0 vs. 0% [median], P = 0.0467). No treatment difference in A1C was observed.

CONCLUSIONS—Overall rates of low glucose over 24 h were not different but were twice as frequent at night than during the day in individuals with type 2 diabetes. Compared with BHI 30, BIAsp 30 was associated with similar low IG readings over 24 h but with fewer nocturnal episodes and less self-reported nocturnal hypoglycemia.

Abbreviations: BIAsp 30, biphasic insulin aspart 30 • BHI 30, biphasic human insulin 30 • CGMS, continuous glucose monitoring system • IG, interstitial glucose • ITT, intent to treat

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