Randomized and comparative study analyzing efficacy and safety profile of sitagliptin in early diabetic nephropathy

Abstract

Background: Diabetes mellitus is the most common cause of chronic kidney disease. Microalbuminuria is an early sign of diabetic nephropathy. Angiotensin converting enzyme (ACE) inhibitors decrease albumin excretion and prevent its progression. Sitagliptin is a novel therapeutic agent for Type 2 diabetes mellitus. Hence, this study was carried out to investigate the effect of sitagliptin in albuminuria along with ACE inhibitors and its efficacy, and safety of glycemic profile in diabetic nephropathy. Aims and Objectives: This study evaluated the efficacy of sitagliptin in retarding the progression of albuminuria, and assessing its safety of glycemic profile in patients with Type 2 diabetes with early stage of nephropathy. Materials and Methods: In this randomized and open-label study, patients with diabetic nephropathy were randomized to two groups (n = 30 each). The control group received oral Anti Diabetic Drugs+ Tab. Enalapril 2.5 mg and the study group received antidiabetic drug + Tab. Enalapril 2.5 mg+ Tab. Sitagliptin 100 mg. The patients were evaluated at the end of 24 weeks. Results: Urinary albumin creatinine ratio decreased from 302.10 to 143.83 at 24 weeks in the sitagliptin-treated group (P = 0.001) and in the control group UCAR value reduced from 324.10 to 290.93 mg/g. Statistically significant reductions in hemoglobin, fasting blood sugar, post-prandial blood sugar, and systolic blood pressure were observed in the sitagliptin-treated group. Adverse effects reactions were less in the study group (10%) than in the control group (26%). Conclusion: Sitagliptin significantly reduced albuminuria and improved glycemic control and was well tolerated in patients with early-stage diabetic nephropathy.