ORIGINAL PAPER

Low risk of severe hypoglycaemia in patients with type 2 diabetes mellitus starting insulin therapy with premixed insulin analogues BID in outpatient settings

  1. V. Pīrāgs1,
  2. H. El Damassy2,
  3. M. Dąbrowski3,
  4. M. S. Gönen4,
  5. E. Račická5,
  6. E. Martinka6,
  7. J. Giaconia7,
  8. A. Stefanski8,
  9. On Behalf of the B001 Study Investigators

Article first published online: 16 OCT 2012

DOI: 10.1111/j.1742-1241.2012.03001.x

Issue

International Journal of Clinical Practice

International Journal of Clinical Practice

Volume 66, Issue 11, pages 1033–1041, November 2012

Additional Information

How to Cite

Pīrāgs, V., El Damassy, H., Dąbrowski, M., Gönen, M. S., Račická, E., Martinka, E., Giaconia, J., Stefanski, A. and On Behalf of the B001 Study Investigators (2012), Low risk of severe hypoglycaemia in patients with type 2 diabetes mellitus starting insulin therapy with premixed insulin analogues BID in outpatient settings. International Journal of Clinical Practice, 66: 1033–1041. doi: 10.1111/j.1742-1241.2012.03001.x

Author Information

  1. 1

    Faculty of Medicine, University of Latvia, Riga, Latvia

  2. 2

    Ain Shams University, Cairo, Egypt

  3. 3

    Department of Public Health and Nursing, Faculty of Medicine, University of Rzeszów, Rzeszów, Poland

  4. 4

    Department of Endocrinology and Metabolism, School of Medicine, Selcuk University, Konya, Turkey

  5. 5

    Diabetologicka Ambulance, Outpatient Diabetology Department, Ostrava, Czech Republic

  6. 6

    Department of Diabetology, National Institute of Endocrinology and Diabetology, Lubochna, Slovakia

  7. 7

    INC Research, Cincinnati, OH, USA

  8. 8

    Eli Lilly Polska, Warsaw, Poland

*Adam Stefanski, Eli Lilly Polska, Warsaw, Poland Tel.: +48 22 440 33 47 Fax: +48 22 440 35 50 Email: stefanski_adam@lilly.com

  1. Disclosures VP, HED, MD, MSG, ER, EM none. JG employed by INC Research, a contract research company with Eli Lilly and Company. AS employed by and owns stock in Eli Lilly and Company.

Publication History

  1. Issue published online: 16 OCT 2012
  2. Article first published online: 16 OCT 2012
Corrected by:

Erratum: Erratum

Vol. 67, Issue 6, e1, Article first published online: 16 MAY 2013

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Summary

Aims:  The choice of insulin at initiation in type 2 diabetes remains controversial. The aim of this study was to assess the occurrence of self-reported severe hypoglycaemia associated with premixed insulin analogues in routine clinical care.

Methods:  A 12-month, prospective, observational, multicentre study in patients starting a commonly prescribed premixed insulin analogue (either insulin lispro 25/75 or biphasic insulin aspart 30/70, twice daily) after suboptimal glycaemic control on oral antidiabetic agents. Treatment decisions were made solely in the course of usual practice.

Results:  Study follow-up was completed by 991 (85.5%) of the 1150 patients enrolled. At baseline, mean (SD) age was 57.9 (10.1) years; mean diabetes duration was 9.2 (5.9) years; mean haemoglobin A1c (HbA1c) was 9.9 (1.8) % and the rate of severe hypoglycaemia was 0.03 episode/patient-year. At 12 months, the rate of severe hypoglycaemia was 0.04 episode/patient-year (95% CI 0.023, 0.055 episode/patient-year) and mean insulin dose was 41.5 (19.4) units. Changes from baseline to 12 months for mean fasting plasma glucose and HbA1c were −5.1 mmol/l and −2.5%, respectively.

Conclusions:  After initiation of premixed insulin analogues in patients with type 2 diabetes in real-world settings, the incidence of severe hypoglycaemia was lower than expected from previously reported studies.

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