SITAGLIPTIN;

Abstract

The objective of this stidy is to compare the mean reduction of HbA1c in patientstaking sitagliptin insulin combination with insulin alone in patients of type II Diabetes mellitus.Study Design: Randomized control trial (RCT). Setting: Medicine Department, Allied Hospital,Faisalabad. Period: August 2013 to February 2014. Methodology: Patients of both genderswith ages between 18 and 60 years having uncontrolled type 2 diabetes mellitus with HbA1ctaking insulin were included in the study while Pregnant or lactating mothers, patients withchronic liver disease and patients with renal insufficiency (creatinine >3.0mg/dl) were excludedfrom study. Patients were randomly divided into two groups (A &B) using computer generatedrandom number table. Group A was given Sitagliptin 50mg per day and dose was increasedto 100mg per day after 2 weeks if fasting blood sugar was more than 110mg/dl or 2 hourspostprandial blood sugar more than 140mg/dl. Dose of insulin in group A remained same asbefore start of study. Group B was kept on same regimen of insulin they were already taking anddose remained same. HbA1c was done at start of study and after 24 weeks. Primary outcomemeasure was mean reduction in HbA1c levels at 24 weeks from baseline. Results: 60 patientswere included in the study. Mean age was 52.7+8.43 years. 36(60%) were male and 24(40%)were female. Mean HbA1c at baseline was 8.361+0.523% in Group A on Sitagliptin-insulincombination and 8.187+0.432% in group B on insulin alone. Mean HbA1c at 24 weeks was7.767+0.428% in group A on Sitagliptin-insulin combination and 7.69+0.407% in group B oninsulin alone.Independent sample t-test was applied to change in HbA1c in Group A and Bduring 24 weeks of treatment. Mean change in HbA1c after 24 weeks in Group A was 0.600+ 0.315 and 0.49+ 0.19 in Group B after 24 weeks treatment (p-value 0.002) which is highlysignificant. Paired sample t-test was applied to HbA1c at baseline and 24 weeks of treatmentin group A and group B. There was a significant change in both groups after 24 weeks oftreatment in both groups (p-value <0 .000) which is highly significant. Chi Square test wasapplied on efficacy in group A and B. 22(73.33%) patients in group A and 14(46.67%) patientsin group B which achieved significant reduction in HbA1c. 8(26.67%) patients in group A and16(53.33%) patients in group B failed to achieve significant reduction in HbA1c. (P-value <0.032). Conclusion: It has been concluded from this study that insulin and sitagliptin-insulincombination both significantly reduce HbA1c in type 2 diabetes mellitus. However addition ofsitagliptin to uncontrolled diabetic patients already taking insulin, is more effective than insulinfor glycemic control of patients with type 2 diabetes mellitus.