A significant number of patients with Type 1 diabetes do not achieve glycemic targets despite appropriate insulin therapy. Hence, adjunctive therapies are being continually explored for its management. We conducted this study to evaluate the utility of dipeptidyl peptidase 4 inhibitor (Sitagliptin) in combination with insulin therapy.
This study was conducted in the out-patient setting of Department of Endocrinology, Care Hospital, Hyderabad. Subjects diagnosed to have Type 1 Diabetes with HbA1c greater than 7% were included in the study after informed was taken. Forty seven subjects were randomized to either group A that received Sitagliptin 100mg PO as add on therapy to insulin (n = 24) or group B that received insulin alone (n = 23). All patients were on basal bolus regimen (regular Insulin and NPH insulin) and continued to titrate the dose to reach target blood glucose levels. Change in HbA1c, total daily dose of insulin, body weight, and the number of hypoglycemic events during the duration of the study were recorded. The primary endpoint was change from baseline in HbA1c at the end of 3 months; the secondary endpoints being total daily dose reduction of insulin, safety and tolerability of Sitagliptin.
Two patients in each group were lost to follow up. Two patients in each group dropped out. 20 patients in each group completed the study. At the end of the treatment period, both groups had similar reduction in HbA1c. However, there was significant reduction in the number of episodes of hypoglycemia (2.5 ± 0.8 Vs 5.7 ± 1.3; p 0.0001) in the patients receiving Sitagliptin. There was a reduction in the dose of insulin in Group A from 79.75± 25.7 to. 74.15 ± 23.99 at the end of the study (p 0.0003); on the other hand the insulin requirement increased in Group B from 76.45 ± 27.1 to 90.05 ± 31.92 (p 0.0001). However, there was no statistically significant difference in insulin dose between the two groups at the end of the study period (p 0.08). Similarly, no difference in body weight was noted between groups. Patients receiving Sitagliptin had greater episodes of nausea and vomiting (6 vs. 0; p 0.02)
Discussion : The study suggests that sitagliptin is non inferior to insulin ttration n the management of patients with Type 1 Diabetes mellitus. Also there were less episodes of hypoglycaemia in patients in the sitaglptin group; but there was increased incidence of gastrointestinal intolerance.
Sitagliptin can be considered as an alternative to progressive up titration of insulin in type 1 diabetics sub-optimally controlled with insulin. Reduction in the incidence of hypoglycemia is an additional benefit.
Harsh Parekh– Consultant Endocrnologist, Thunga Hosptal, Malad, Mumbai, Maharashtra, India
Bipin Sethi– Consultant Endocrinologist, CARE Hospital, Hyderabad, Hyderabad, Telangana, India
Vaibhav Dukle– Senior Resdent Endocrinology, CARE Hospital, Hyderabad, Hyderabad, Telangana, India
Thunga Hosptal, Malad
Mumbai, Maharashtra, India
currently working as consultant endocrinologist at thunga hospital malad
CARE Hospital, Hyderabad
Hyderabad, Telangana, India
Currently working as consultant endocrinologist at Care Hospital Hyderabad