Publication:

Comparative study of efficacy and safety of sitagliptin versus glimepiride in patients of type-2 diabetes mellitus inadequately controlled with metformin alone

Background Di-peptidyl peptidase-4 inhibitors when used as monotherapy or in combination with other drugs such as metfomin, thiazolidinedione or sulphonylurea are effective and well tolerated in diabetes management. The aim was to evaluate the safety and efficacy of sitagliptin compared to glimepiride as a dual therapy for the treatment of type-2 diabetes patients inadequately controlled with metformin.

Methods It was an observational, open, comparative and multiple follow up study, included 70 patients visiting department of medicine and department of pharmacology at Gandhi Medical College and associated Hamidia Hospital, Bhopal, Madhya Pradesh, India for the period of 1 year. Patients of type 2 diabetes who were on metormin at least for last 3 months and were with inadequate glycemic control (HbA1C levels >7% and <10%) were included. All the patients were divided into two groups: Group G (35 patients; received glimepiride 2 mg per day) and Group S (35 patients received sitagliptin 100 mg per day). Treatment was provided for the period of 18 weeks and patients were called for 3 follow ups at the end of 4, 12 and 18 weeks. All the patients were investigated for glycated hemoglobin (HbA1c), fasting blood glucose (FBG) and post prandial glucose (PPG) along with adverse drug reaction if any.

Results Female predominance was observed with mean age of study population being 48.07±10.07 years. Mean duration of diabetes and weight at baseline in Group G was 4.56±1.24 years and 48.23±2.15 kgs respectively and in Group S was 4.34±1.12 years and 49.61±3.21 kgs respectively. Mean dose of Metformin was 1819 mg/day. Mean glycated hemoglobin (HbA1c), fasting plasma glucose (FBG) and post prandial glucose (PPG) at baseline and 18th week in Group G was 8.31±0.12 % and 7.42±0.22%, 186.34±58.09 mg/dl and 109.9±17.69 mg/dl, 261.9±67.92 mg/dl and 159.21±15.96 mg/dl respectively whereas in Group S was 8.56±0.11% and 7.75±0.31%, 194±48.24 mg/dl and 112.3±15.58, 287.27±62.04 mg/dl and 162.6±.16.42 mg/dl respectively. In Group G weight of the patients increased from 64.59±7.9 kgs at baseline to 66.06±8.02 kg at 18 weeks of treatment whereas in Group S body weight of patients decreased from 62.06±7.02 kgs to 60.57±6.66 kgs at 18 weeks of sitagliptin treatment. The incidence of hypoglycemia (0%), nausea (6.06%) and vomiting (3.03%) in sitagliptin group was low as compared to glimepiride group (hypoglycemia (3.12%), nausea (12.5%) and vomiting (6.25%)).

Conclusions Addition of sitagliptin in patients who are inadequately controlled with metformin monotherapy provide similar efficacy but better safety as compared to glimepiride.