Background: This preliminary study is aimed at the evaluation of the efficacy and tolerability of combined therapy with gliclazide and metformin in the treatment of patients with type 2 diabetes mellitus inadequately controlled with maximal doses of gliclazide.
Methods: A prospective, uncontrolled study, with a follow-up of 3 months, was performed in two Outpatient Diabetes Care Units. Fifty-seven patients affected by type 2 diabetes for at least 5 years, aged 61.0 +/- 3.4 years, with a duration of diabetes of 9.2 +/- 3.9 years, Body Mass Index (BMI) 30.5 +/- 3.7 kg/m2, previously treated with gliclazide 240 mg/day, and with HbA1c > 8.5%, were studied. The patients were treated with gliclazide 120 mg/day and metformin 1500 mg/day for 3 months; HbA1c, 24-hour glycosuria, and fasting and post-prandial glycaemia, were determined at the beginning and at the end of the study.
Results: After a 3-month treatment, a reduction of fasting and post-prandial glycaemia, glycosuria (15.0 +/- 5.3 versus 5.7 +/- 4.0 g/l, p < 0.01), and HbA1c (9.9 +/- 1.1 versus 8.4 +/- 1.0%, p < 0.01) was observed, while no significant changes occurred in body weight. The treatment was generally well tolerated.
Conclusions: In conclusion, the combination of gliclazide and metformin, which could theoretically show some advantages over the association of glibenclamide and metformin with regards to lipid and haemorheologic profiles, resulted to be effective and well tolerated in patients with type 2 diabetes inadequately controlled with sulphonylurea monotherapy.