Efficacy and safety of sitagliptin, metformin and pioglitazone fixed-dose combination therapy (100 mg/1000mg and 15 mg respectively) as a first-line treatment in obese type 2 diabetes with high insulin resistance

Abstract

Background: Metformin is the first line of treatment in patients with type 2 diabetes. Diabetes being a metabolic disorder, improvement does not occur just with metformin. The pharmacotherapy course then changes to a fixed combination of drugs that have complementary mechanisms to those of metformin.

Aim: To assess the efficacy and safety of anti-diabetic drugs individually and in combination. Here, sitagliptin was compared with a fixed dosage combination of metformin and sitagliptin and pioglitazone alone in diabetic patients who had HbA1c of more than 7.5% and less than 12.0%

Method: In total, 40 weeks of study were divided into two phases. Phase A patients were divided into two groups and given sitagliptin and pioglitazone. In the second phase, the patients with sitagliptin were given a combination of sitagliptin and metformin, and the second group of patients were up-titrated with the dose of pioglitazone

Results: At the end of phase A, HbA1c levels decreased in both groups, and similar results were obtained for blood sugar levels fasting as well as post-prandial. In phase B a decrease was obtained in both HbA1c and blood glucose levels in fasting and postprandial; this decrease was observed to be significant compared to the first phase. When the adverse drug reaction of the combination and individual drugs were compared, such incidences were lesser in the case of combination pharmacotherapy

Conclusion: The decrease in the glycemic levels was more in the case of combination therapy compared to monotherapy. However, both types of therapy were well tolerated.

Keywords: combination of sitagliptin and metformin, pioglitazone, treatment of type 2 diabetes mellitus