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Comparative evaluation of safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus: Indian multicentric randomized trial - START Study
TV Devarajan1, S Venkataraman2, Narayanan Kandasamy3, Abraham Oomman4, Hari Kishan Boorugu5, S. K. P. Karuppiah6, Dushyant Balat7
1 Consultant Physician, Apollo First Med Hospitals, Chennai, Tamil Nadu, India
2 Consultant Physician and Diabetologist, Apollo Hospitals, Chennai, Tamil Nadu, India
3 Consultant Endocrinologist and Diabetologist, Apollo Hospitals, Chennai, Tamil Nadu, India
4 Consultant Cardiologist, Apollo Hospitals, Chennai, Tamil Nadu, India
5 Consultant Physician, Apollo Hospitals, Hyderabad, Telangana, India
6 Consultant Cardiologist, Apollo Speciality Hospital, Madurai, Tamil Nadu, India
7 Consultant Cardiologist, Apollo Hospitals International Limited, Ahmedabad, Gujarat, India
Correspondence Address:
S Venkataraman
Apollo Hospitals, No. 21, Greams Lane, Off Greams Road, Thousand Lights, Chennai - 600 006, Tamil Nadu
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijem.IJEM_176_17
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Background and Objective: Modern sulfonylureas like glimepiride offer effective glycemic control with extrapancreatic benefits and good tolerability. The objective of the present study was to evaluate and compare safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus (T2DM). Methods: In this open-label, randomized, comparative, multicenter study, a total of 305 T2DM patients who were either drug naïve or uncontrolled on metformin were randomized to glimepiride 1 or 2 mg/sustained-release metformin 1000 mg once daily (glimepiride group, n = 202) or sitagliptin 50 mg/metformin 500 mg twice daily (sitagliptin group, n = 103) for 12 weeks. Primary endpoint was change in glycosylated hemoglobin (HbA1c). Secondary endpoints were change in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), body mass index (BMI) and to assess overall safety profile. Results: At 12 weeks, there was a statistically significant difference in the mean HbA1c reduction in glimepiride group (0.42%) as compared to sitagliptin group (0.30%) (P = 0.001). Mean reduction in FPG and PPG was also statistically significant in the glimepiride group as compared to the sitagliptin group (P = 0.008). There was no significant difference in terms of change in BMI (0.07 ± 0.39 kg/m2 vs. 0.08 ± 0.31 kg/m2) in glimepiride and sitagliptin groups, respectively, (P = 0.644) between both the groups. The incidences of hypoglycemic events were also comparable among both the groups. Conclusion: In T2DM patients, glimepiride/metformin combination exhibited significant reduction in glycemic parameters as compared to sitagliptin/metformin combination. Moreover, there was no significant difference between both the groups in terms of change in BMI and incidence of hypoglycemia.
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