Interní Med. 2011; 13(10): 409-412
Human insulin vs. insulin analogue: results of a prospective, multi-centre, open-labelled, non-interventional,
- 3. interní klinika 1. LF UK, Praha
24-week observational study in type 2 diabetics taking NovoRapid®, NovoMix® or Levemir®
A large observational study aimed at the treatment with modern insulins was carried out in the Czech Republic in the years 2008 and
2009. It included 266 centres in which a total of 4824 patients were enrolled. The primary outcome was observation of improvement in
HbA1C (IFCC) levels after switching from treatment with human insulin to that with modern insulins (insulin analogues) in the treatment
of type 2 diabetes. The secondary outcomes were observation of some other parameters of diabetes control and the safety of treatment
with insulin analogues. Four groups of patients were observed in the study according to the method of treatment with human insulin (or
insulins) from which the patients were switched to insulin analogues. Only „pure switches“ were observed: A) from treatment with human
insulins in a basal-bolus regimen to treatment with analogues in a basal-bolus regimen – NovoRapid® and Levemir®; B) from treatment
with human insulin in a basal regimen to treatment with an analogue in a basal regimen – Levemir®; C) from treatment with premixed
human insulin to that with a premixed analogue – NovoMix®; and D) from treatment with human insulin administered prandially to
that with an analogue administered prandially – NovoRapid®. In all the groups, there was a statistically significant reduction in glycated
haemoglobin levels, fasting glycaemia and postprandial glycaemia after 12 and 24 weeks of treatment with insulin analogues. The treatment
with insulin analogues was shown to be safe with no severe or other adverse events reported during its course. After switching to
insulin analogues, there was a decrease in the rates of hypoglycaemia.
Keywords: type 2 diabetes, insulin treatment, insulin analogues, observational study
Published: October 1, 2011 Show citation
