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

Manuj Sharma, Rakesh Sonawane, J.L. Marko


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.


Sitagliptin, Glimepiride, Combination therapy, Hypoglycemia

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Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. J Am Med Asso. 2004;291:335-42.

Mane PB, Antre RV, Oswal RJ. Antidiabetic drugs: an overview. Int J Pharmaceutical Chemical Sci. 2012;1:301-6.

Kimmel B, Inzucchi SE. Oral agents for type 2 diabetes: an update. Clinical Diabetes. 2005;23(2):64-76.

Ferreira AJC, Amatruda JM. Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type-2 diabetes: a randomized, double-blind trial. Diabetes Obes Metab. 2010;12:613-22.

Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Herman WDE. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007;30:1979-87.

Jacques N. New NICE guidelines for type II diabetes treatment. clinical update: Br J Clinic Pharm. 2009;1:167-8.

American diabetes association. Approaches to glycemic treatment. Diabetes Care. 2016;39(1):52-9.

Gadsby R. Efficacy and safety of sitagliptin in the treatment of type 2 diabetes. Clinic Med Therap. 2009;1:53-62.

Kurebayashi S, Motomura T, Goya K, Nakao M, Hashimoto K. Sitagliptin significantly decreases the ratio of glycated albumin to HbA1c in patients with type 2 diabetes mellitus. J Diabetes Metab. 2014;5:343.

Srivastava S, Saxena GN, Keshwani P, Gupta R. Comparing the efficacy and safety profile of sitagliptin versus glimepiride in patients of type 2 diabetes mellitus inadequately controlled with metformin alone. Japi. 2012;60:27-30.

Anjoom M, Dutta S, Beg MA, Varma A, Bawa S, Kant R. Comparative evaluation of combination of metformin and glimepiride with that of metformin and sitagliptin in type 2 diabetes mellitus with respect to glycemic targets. Int J Med Sci Public Health. 2015;4:476-80.

Reasner C, Olansky L, Seck TL, Herman WDE, Chen M, Terranella L, et al. The effect of initial therapy with fixed dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011;13:644-52.

Hou L, Zhao T, Liu Y, Zhang Y. Efficacy and safety of sitagliptin compared with sulfonylurea therapy in patients with type 2 diabetes showing inadequately controlled glycosylated hemoglobin with metformin monotherapy: a meta-analysis. Experimental Therap Med. 2015;9:1528-36.

Hayati F, Hazim A, Sasongko TH, Siew HG, Wan WMI, Daud J, et al. Efficacy and safety of sitagliptin as a third therapeutic agent in the treatment of type 2 diabetes mellitus. J Diab Res Clin Met. 2014;3:10.

Kumar S, Pathak AK, Saikia D, Kumar A. Efficacy,safety and treatment satisfaction of glimepiride vs sitagliptin in combination with metformin in type 2 diabetes mellitus. J Clinic Diagnos Res. 2015;9(12):07-10.

Arechavaleta R, Seck T, Chen Y, Krobot KJ, Oneill EA, Duran L et al. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. Diabetes, Obesity and Metabolism. 2011;13:160-8.