Background: Several efficacy studies of insulin-therapy regimens in patients with type 2 diabetes mellitus have shown varying results. Moreover, most studies did not address hypoglycaemia frequency and severity.
Methods: In this multicentre study, we compared the glycaemic efficacy and incidence rate of hypoglycaemic episodes between 3 treatment regimens in obese type 2 diabetic patients with secondary failure to sulphonylurea and metformin. During the run-in phase, patients were treated with glimepiride and metformin. After 3 months, 261 patients with HbA(1c) values >6.5% were randomised to (A) glimepiride + Neutral Protein Hagedorn (NPH) insulin at bedtime, (B) NPH insulin twice daily and (C) 30/70 mixture of short-acting and NPH insulin twice daily. The therapeutic aim was an HbA(1c) level < or =6.5%.
Results: Mean HbA(1c) achieved at 9 months was significantly higher in group A: 8.9% versus 8.3% and 8.4% in groups B and C, respectively (P < 0.001). There was no difference in the mild hypoglycaemic event rate, 0.36 versus 0.48 versus 0.53 events per patient month, in groups A, B and C, respectively. Severe hypoglycaemic events, requiring help from others, did not occur throughout the study. The mean weight gain and insulin dose were comparable in all three groups.
Conclusions: The glimepiride + NPH insulin treatment resulted in a higher HbA(1c) level, as compared to the other regimens. In the clinical setting of this multicentre study, good glycaemic control was only achieved in a minority of the patients, irrespective of the applied regimen.
Copyright 2003 John Wiley & Sons, Ltd.