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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. Paul G. McNally, MD, FRCP1,
  2. John D. Dean, MD, FRCP2,
  3. Andrew D. Morris, MD3,
  4. Peter D. Wilkinson, MA4,
  5. Gerhard Compion, MD5 and
  6. Simon R. Heller, DM, FRCP6
  1. 1Leicester Royal Infirmary NHS Trust, Leicester, U.K.
  2. 2Bolton Diabetes Centre, Bolton PCT/Bolton Hospitals NHS Trust, Bolton, U.K.
  3. 3Division of Medicine and Therapeutics, Ninewells Hospital, Dundee, Scotland, U.K.
  4. 4Wilkinson Associates, Radnage, Bucks, U.K.
  5. 5Novo Nordisk, Broadfield Park, Crawley, West Sussex, U.K.
  6. 6Academic Unit of Diabetes, Endocrinology, and Metabolism, School of Medicine and Biomedical Sciences, Sheffield, U.K.
  1. 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

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 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.

Footnotes

  • Published ahead of print at http://care.diabetesjournals.org on 2 February 2007. DOI: 10.2337/dc06-1328. Clinical trial reg. no. ISRCTN34091554, clinicaltrials.gov, and at clinicalstudyresults.org, no. BIASP-1466.

    Additional information for this article can be found in an online appendix at http://dx.doi.org/10.2337/dc06-1328.

    P.G.M. has received lectures fees from and been a member of advisory boards for Novo Nordisk. J.D.D. has received honoraria from and been a member of advisory boards for Novo Nordisk. A.D.M. has received renumeration to participate on the speakers bureau of Novo Nordisk and was a clinical trial investigator for the REACH study. P.D.W. receives payment for providing statistical consultancy services to Novo Nordisk. S.R.H. has received fees for giving lectures at symposia sponsored by Novo Nordisk and for participating in research activities sponsored by Novo Nordisk and has served on national and international advisory boards sponsored by Novo Nordisk. Novo Nordisk manufactures and markets the insulin products used in the REACH trial.

    A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.

    • Accepted January 21, 2007.
    • Received June 26, 2006.
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This Article

  1. Published online before print February 2, 2007, doi: 10.2337/dc06-1328 Diabetes Care vol. 30 no. 5 1044-1048
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