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



This article is corrected by:

  1. Errata: Erratum Volume 67, Issue 6, e1, Article first published online: 16 May 2013

  • 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.

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


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.