A PROSPECTIVE STUDY OF ADDITION OF SITAGLIPTIN TO METFORMIN VERSUS METFORMIN ALONE IN TYPE 2 DIABETES MELLITUS PATIENTS

Abstract

Ramswaroop Jawaharlal 1 , Pravin G. Maske

BACKGROUND Various oral hypoglycaemic agent has been used for the treatment of diabetes mellitus. Out of that, metformin is a biguanide, which is commonly used for the treatment of diabetes mellitus and sitagliptin is an orally effective inhibitor of dipeptidyl peptidase IV, which indirectly increase the secretion of insulin by preventing degradation of GLP-1. Present study is designed to evaluate the efficacy of addition of sitagliptin with metformin in comparison with metformin alone. MATERIALS AND METHODS Subjects included in this study were randomised into two groups. Group A were given metformin 500 mg once daily and group B was given metformin 500 mg plus sitagliptin 50 mg. Both the group consists of 30 patients each. Before start of the study, various parameter like fasting plasma glucose, postprandial plasma glucose, glycosylated haemoglobin, HDL-C, LDL-C, TG total cholesterol, fasting plasma insulin, glycosylated haemoglobin and HOMA-IR were measured. All the patients were followed regularly and advice regarding diet and regular exercise was given. Fasting plasma glucose was measured every 15 days. All the patients were informed about hypoglycaemia and its presentation. Patients were asked to inform about any adverse experience. All the parameters were measured after 16 weeks of treatment. RESULTS Fasting plasma glucose in group A was reduced to 104.6 mg/dL from its basal value 156.45 mg/dL. In group B, the fasting plasma glucose was reduced to 90.10 mg/dL from its basal value 154.7 mg/dL. Fasting plasma insulin in group A was 12.65 mIU/dL, which has been changed to 11.46 mIU/dL after 16 weeks of treatment with metformin 500 mg once daily. Fasting plasma insulin in group B has been decreased from basal value 13.24 mIU/dL to 12.46 mIU/dL at the end of 16 weeks. Glycosylated haemoglobin in group A was 7.64 at the start of study, which was decreased to 6.0 after 16 weeks treatment with metformin similarly in group B HbA1c was decreased from basal value 7.86 to 5.8 after 16 weeks of treatment. The HOMA-IR value also decreased in both group. In group A, initial value was 4.69, which was reduced to 2.94; and in group B, after 16 weeks, the basal value of 7.86 was reduced to 2.77. CONCLUSION Diabetes mellitus is a chronic progressive disease responsible for damage of major organ system. In present study, we have found that BMI and glycaemic index was improved when sitagliptin was added to metformin. Insulin resistance was better improved in sitagliptin combination group metformin alone. Sitagliptin addition is associated with increase in HDL-C.

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