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.
Low risk of severe hypoglycaemia in patients with type 2 diabetes mellitus starting insulin therapy with premixed insulin analogues BID in outpatient settings
Article first published online: 16 OCT 2012
© 2012 Blackwell Publishing Ltd
International Journal of Clinical Practice
Volume 66, Issue 11, pages 1033–1041, November 2012
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
- Issue published online: 16 OCT 2012
- Article first published online: 16 OCT 2012
Vol. 67, Issue 6, e1, Article first published online: 16 MAY 2013
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.