AN OBSERVATIONAL STUDY COMPARING SITAGLIPTIN TO METFORMIN AS A INITIAL MONOTHERAPY IN TYPE 2 DIABETES MELLITUS PATIENTS

AIM: An Observational study Comparing sitagliptin to metformin as an initial monotherapy in type 2 diabetes mellitus patients. METHOD: In this observational study we have selected 100 patients which divided into two groups; first group was on sitagliptin and second group was on metformin. The criterion for inclusion in the study was 1) Age group of 18 - 78 years 2) HbA1c of 6.5 - 9.0%. Group A was started on sitagliptin 50 to 100 mg. Group B patients were started on Metformin, dosage of 500 mg once a day and the dose was increased to a of maximum of 2000 mg; and this study was done for 12 weeks. RESULTS AND STATISTICAL ANALYSIS: Group A comprises 50 patients whose baseline FBS, PPBS, HbA1C was determined, Group B comprises 50 patients whose baseline FBS, PPBS, HbA1C was determined. The results of HbA1c obtained before and after the sitagliptin and metformin therapy was analyzed using SPSS V 20 software using paired t test and chi square analysis. It was observed that the mean baseline hba1c in the group A patients was 7.8 % and in group B was 7.95% whereas the mean HbA1c after 12 weeks of therapy was 7.44% and 7.73% respectively in the Group A and B. There was a significant decrease in Hba1c in both groups with t (49) value Group A (7.89, p < 0.001) Group B (3.48, p 0.001). There was a significantly positive correlation (p< 0.001) in two groups, A (r = 0.903) having higher positive correlation than group B (r= 0.748), whereas the mean difference in Hba1c was higher for group A (0.36) compared to group B (0, 21) suggesting a greater decrease in Hba1c with sitagliptin compared to metformin, as the mean difference was significant the effect size (d) was calculated it was observed that the effect size for group A was (d= 1.16) larger than group B (d= 0.49). Occurrence of Various symptoms such as nausea, headache and diarrhoea were seen in two groups and it was observed that nausea was greater in group A (16%) compared to B (8%), the increase was observed to b non-significant at p = 0.35, headache was greater in group B (10%) compared to A (5%), the increase was observed to b non-significant at p = 1.0, Diarrhoea was greater in group B (18%) compared to A (2%), the increase was observed to b significant at p = 0.016 with a likelihood ratio of 8.0. CONCLUSION: In this 12 week study sitagliptin was not inferior compared to metformin in controlling the Hba1C in patients with type 2 diabetes mellitus. Both the group; patients well tolerated and the incidence of gastrointestinal adverse effects were lower in the patients on sitagliptin.