Aim: This Swiss multicentre study examined the efficacy and safety of oral pioglitazone in patients with type 2 diabetes.
Methods: Patients were randomised to pioglitazone at once-daily doses of 30 mg for 20 weeks (n = 76), 30 mg for 12 weeks followed by 45 mg for 8 weeks (n = 74), or 45 mg for 20 weeks (n = 84); 94.9% of patients completed 12 weeks and 88.9% completed all 20 weeks. Almost all (96.6%) patients received pioglitazone in combination with other anti-diabetic treatments.
Results: Mean HbA(1c) at baseline was 8.8 +/- 1.2%, and changes to endpoint were -1.1 +/- 1.1%, -1.1 +/- 1.4% and -0.9 +/- 1.6%, respectively for the three dose groups ( p < 0.001 for each group). Triglyceride concentrations decreased in each group and the overall mean change during the study was -0.58 mmol/l (p < 0.001 versus baseline). HDL-cholesterol increased, with an overall mean change of 0.10 mmol/l (p < 0.001 versus baseline). Blood pressure decreased from baseline, particularly for hypertensive patients with mean changes: systolic -10 mmHg, p < 0.001, diastolic -8 mmHg, p < 0.001 versus baseline. Serum alanine aminotransferase and gamma-glutamyl transferase concentrations were significantly (p < 0.001 for each) reduced during the study.
Conclusions: The study demonstrates the efficacy of pioglitazone 30 mg/day and 45 mg/day in the treatment of type 2 diabetes, with an improved lipid profile and decreased blood pressure in addition to improved glycaemic control.