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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

¹Leicester Royal Infirmary NHS Trust, Leicester, UK
²Bolton Diabetes Centre, Bolton PCT/Bolton Hospitals NHS Trust, Bolton, UK
³Division of Medicine & Therapeutics, Ninewells Hospital, Dundee, Scotland, UK
⁴Wilkinson Associates, Radnage, Bucks, UK
⁵Novo Nordisk Ltd, Broadfield Park, Crawley, West Sussex, UK
⁶Academic Unit of Diabetes, Endocrinology and Metabolism, Room OU141, School of Medicine and Biomedical Sciences, Beech Hill Road, Sheffield S10 2RX, UK

s.heller{at}sheffield.ac.uk

ABSTRACT

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 continuous glucose monitoring (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 (BIAsp 30) or biphasic human insulin (BHI 30).

RESEARCH DESIGN AND METHODS: A double-blind, two-period, cross-over 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 (LIG) were found. 24-h plots of CGMS showed LIG was more frequent at night as during the day, and unrecognized by patients. At night, subjects spent significantly less time (% of total CGMS recorded) with IG <3.5 and <2.5 mmol/l during BIAsp 30 than during BHI 30 treatment (<3.5 mmol/l: 6.36 vs. 7.93% [mean], 0.67 vs. 2.43% [median], respectively, P = 0.018; <2.5 mmol/l: 2.35 vs. 2.86% [mean], 0 vs. 0% [median], P = 0.0467). No treatment difference in HbA_1c was observed.

CONCLUSIONS: Overall rates of low glucose over 24 h were not different, but were twice as frequent at night as 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 fewer nocturnal episodes and less self-reported nocturnal hypoglycemia.

Trial registration details- This trial was registered at ISRCTN, registration number: ISRCTN34091554 and at ClinicalStudyResults.org, Unique ID: BIASP-1466.

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