SITAGLIPTIN AS ADD ON THERAPY TO PATIENTS ON INSULIN.
Keywords:Type 2 Diabetes Mellitus,, Insulin,, Sitagliptin.
The objective of this stidy is to compare the mean reduction of HbA1c in patients
taking 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 genders
with ages between 18 and 60 years having uncontrolled type 2 diabetes mellitus with HbA1c
taking insulin were included in the study while Pregnant or lactating mothers, patients with
chronic liver disease and patients with renal insufficiency (creatinine >3.0mg/dl) were excluded
from study. Patients were randomly divided into two groups (A &B) using computer generated
random number table. Group A was given Sitagliptin 50mg per day and dose was increased
to 100mg per day after 2 weeks if fasting blood sugar was more than 110mg/dl or 2 hours
postprandial blood sugar more than 140mg/dl. Dose of insulin in group A remained same as
before start of study. Group B was kept on same regimen of insulin they were already taking and
dose remained same. HbA1c was done at start of study and after 24 weeks. Primary outcome
measure was mean reduction in HbA1c levels at 24 weeks from baseline. Results: 60 patients
were 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-insulin
combination and 8.187+0.432% in group B on insulin alone. Mean HbA1c at 24 weeks was
7.767+0.428% in group A on Sitagliptin-insulin combination and 7.69+0.407% in group B on
insulin alone.Independent sample t-test was applied to change in HbA1c in Group A and B
during 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 highly
significant. Paired sample t-test was applied to HbA1c at baseline and 24 weeks of treatment
in group A and group B. There was a significant change in both groups after 24 weeks of
treatment in both groups (p-value <0 .000) which is highly significant. Chi Square test was
applied on efficacy in group A and B. 22(73.33%) patients in group A and 14(46.67%) patients
in group B which achieved significant reduction in HbA1c. 8(26.67%) patients in group A and
16(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-insulin
combination both significantly reduce HbA1c in type 2 diabetes mellitus. However addition of
sitagliptin to uncontrolled diabetic patients already taking insulin, is more effective than insulin
for glycemic control of patients with type 2 diabetes mellitus.