Study comparing the effect of pioglitazone in combination with either metformin or sulphonylureas on lipid profile and glycaemic control in patients with type 2 diabetes (ECLA)

Objective: To explore whether the improvement of lipid profile and glycaemic control observed in randomized control trials with pioglitazone (PIO) is replicated under conditions of general clinical practice. Research design and methods: We studied 2388 patients with type 2 diabetes (T2DM) not adequately controlled by monotherapy on either metformin (MET) or sulphonylurea (SU). Addition of a second drug, according to the treating physician's choice, resulted in three groups, PIOMET, PIOSU and METSU, followed for twelve months, while efficacy and safety parameters were measured at baseline, at six and at twelve months. Results: A total of 2116 (88.6) patients completed the study. Diabetic control and lipid profile improved in all three groups, but the improvement was always greater in the two PIO groups. At 12 months PIOSU and PIOMET groups compared to SUMET showed greater increase in HDL cholesterol (8.3 and 9.2 versus 4.3 p