Aims: A European, randomized, 29-centre, open-label study compared the safety and efficacy of two formulations of insulin glargine and neutral protamine Hagedorn (NPH) human insulin, in combination with oral agents, in patients with Type 2 diabetes mellitus (DM).
Methods: Two-hundred-and-four patients with Type 2 DM, in whom oral treatment alone was inadequate, were randomized to insulin glargine with 30 micro g/ml zinc [insulin glargine (30)], or insulin glargine with 80 micro g/ml zinc [insulin glargine (80)] or NPH insulin subcutaneously once daily. Insulin was titrated to aim for fasting blood glucose (FBG) values between 4 and 7 mmol/l. All participants received oral therapy during the 3-week titration phase and 1-week maintenance phase of the trial.
Results: No differences between treatment groups were observed in adjusted mean fasting plasma glucose; significant decreases of 3.4 mmol/l, 3.5 mmol/l and 3.1 mmol/l were observed within the insulin glargine (30), insulin glargine (80) and NPH insulin groups, respectively (P<0.0001 in each case). No differences between groups, but significant changes within groups, were observed in self-monitored FBG, mean FBG, blood glucose profile, stability of FBG, nocturnal blood glucose, fasting serum C-peptide, non-esterified fatty acids, haemoglobin A1c, fructosamine and fasting serum insulin. A significantly greater proportion of NPH insulin patients experienced symptomatic nocturnal hypoglycaemia (19.1 NPH group vs. 7.3% glargine groups; P=0.0123). Both insulins were well tolerated; one patient in each group experienced an injection site reaction.
Conclusions: Insulin glargine is as safe and effective as NPH insulin given once daily and in this study caused fewer episodes of nocturnal hypoglycaemia.