TRIPLE ORAL ANTIDIABETIC OR METFORMIN-BASAL INSULIN COMBINATION: TESTING TWO DIFFERENT APPROACHES OF CONSENSUS ALGORITHM IN ADJUSTING ANTIDIABETIC THERAPY. AN OPEN-LABEL, RANDOMIZED STUDY

Abstract

Objective. The aim of this study was to compare the clinical effects of a triple oral antidiabetic combination versus basal insulin and metformin combination treatment in patients with poorly controlled type 2 diabetes. Methods. Eighty patients with type 2 diabetes, who were treated by metformin and sulphonylurea combination, and had HbA1c values between 7.5 and 10 % (58 and 86 mmol/L), were randomized into two groups. The first group was given triple oral antidiabetic therapy (pioglitazone, metformin, and sulphonylurea) and the second group was given metformin and a bedtime basal insulin (insulin detemir) combination for 12 weeks. Metabolic parameters were evaluated. Results. The mean fasting plasma glucose and HbA1c levels decreased in both groups. The decrease in HbA1c was slightly higher in triple oral antidiabetic group (p=0.046). The patients in triple oral combination group gained 0.2 kg (p=0.881) and those in the metformin-insulin detemir combination group lost 1.7 kg (p=0.001) in 12 weeks (p=0.29 between groups). The frequency of hypoglycemia was higher in triple oral antidiabetic group (11 vs. 2 episodes, respectively). Conclusion. Both sulphonyurea-metformin-pioglitazone and insulin detemir-metformin therapies provided significant improvements in glycemic control. However, sulphonylurea, pioglitazone and metformin combination led to more frequent hypoglycemic events, and weight management seemed in favor of insulin detemir-metformin combination.