DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20185156

Comparison of clinical outcomes of sitagliptin+metformin combination and glimepiride in the management of uncomplicated type 2 diabetics

Jarinabanu Tahashildar, Ravi Shekhar Singh, Jameela Tahashildar

Abstract


Background: To evaluate the comparison of clinical outcomes of sitagliptin +metformin and glimepiride in uncomplicated Type-2 diabetics.

Methods: This one year (July 2016 to August 2017) prospective, open label, observational clinical cohort study was carried out on type-2 diabetics. In this study 299 Type-2 diabetics patients were enrolled and were randomly allocated to two groups viz Group A and Group B. Group A received sitaglitin+metformin (50+500) mg/day and Group B received glimepiride 1mg/day respectively. The follow up started after 10 days of stabilization of the patient and data recorded on 10th day was considered Zero month data and follow up continued up to Six month in each group. Comparison of FPG, PPG and HbA1c was evaluated between zero and six months within group and at six month between groups. Adverse events were recorded and summarized by treatment group.

Results: At the end of six months follow up the patients of Group A who received sitaglitin+metformin (50+500) mg/day had greater reduction in FPG, PPG and HbA1c (all P<0.001) was recorded when compared between zero and six month within group. A significant reduction in FPG, PPG and HbA1c (all P<0.01) also recorded in Group B who received glimepiride 1mg/day when compared between zero and six months within group. A statically significant difference (all P<0.05) was recorded at six months between group. The adverse events like hypoglycemic episodes, gastrointestinal adverse events etc were greater in Group B than Group A. Changes in weight also noted in both Groups. Weight loss in Group A and weight gain in Group B was recorded.

Conclusions: The present study suggests that a significant difference may be existing in the clinical outcome interm of glycemia control and adverse events between sitagliptin+metformin combination and glimepiride in type-2 diabetic patients.


Keywords


Glimepiride, Glycemia control, Sitagliptin+Metformin, Type 2 DM patients

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References


Kumar PJ, Clark M. Diabetes mellitus and other disorders of metabolism. Textbook of Clinical Medicine. Pub: Saunders (London); 2002:1099-1121.

Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of Diabetes Mellitus. Diabetes Care. 1997;20:1183-97.

Beverley B, Eschwège E. The diagnosis and classification of diabetes and impaired glucose tolerance. In: Textbook of Diabetes 1 Ed: John C Pickup and Gareth Williams 3rd ed; Chapter 2 2003;2.1-2.11.

Lindberg G, Lindblad U, Melander A. Sulfonylureas for treating type 2 diabetes mellitus. Cochrane Database Systemic Reviews. 2004;(3).

Amos A, McCarty D, Zimmet P. The rising global burden of diabetes and its complications, estimates and projections to the year 2010. Diabetic Med. 1997;14:1-85.

King H, Aubert R, Herman W. Global burden of diabetes, 1995-2025. Prevalence, numerical estimates and projections. Diabetes Care. 1998;21:1414-31.

Zimmet P. Globalization, coca-colonization and the chronic disease epidemic: can the Doomsday scenario be averted. J Med. 2000;247:301-10.

Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: Estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27:1047-53.

UK prospective Diabetes study (UKPDS) Global prevalence of Diabetes: Estimate for the year 2000 and projections for 2030. Diabetes care. 2004;27:1047-53.

Turner RC, Cull, Fright V, Holman RR. Glycemic control with diet, Sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK prospective Diabetes study (UKPDS) Group. JAMA. 1999:281;2005-12.

Choy M, Lam S. Sitagliptin: a nobel drug for the treatment of type 2 diabetes. Cardiol Rev. 2007;15:264-71.

Inzucchi SE, Maggs DG, Spollett GR, Page SL, Rife FS, Walton V, et al. Efficacy and metabolic effects of metformin and troglitazone in type II diabetes mellitus. New Eng J Med. 1998 Mar 26;338(13):867-73.

Product Information. JANUVIA (sitagliptin). White house Station: Merck and Co., Inc. October 2006.

Davidson Ja, parent EB, Gross JL. Incretin mimetics and Dipeptidyl Peptidase- 4inhibitors; Innovative treatment therapies for type 2 diabetes. Arq Bras Endocrinol Metab. 2008;52/6:1039-49.

Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE. 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.

Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007;9:733-45.

Terauchi Y, Yamada Y, Ishida H, Ohsugi M, Kitaoka M, Satoh J, et al. Efficacy and safety of sitagliptin as compared with glimepiride in J apanese patients with type 2 diabetes mellitus aged ≥ 60 years (START‐J trial). Diabetes, Obesity and Metabolism. 2017 Aug;19(8):1188-92.

Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006;49:2564-71.

Bennett WL, Maruthur NM, Singh S, Segal JB, Wilson LM, Chatterjee R, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med. 2011;154:602-13.

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

Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, et al. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemia control compared with pioglitazone monotherapy in patients with type 2diabetes. Diabetes Obes Metab. 2012;14:409-18.

Nauck M, Meininger G, Sheng DO, Terranella L, Stein PP. Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase‐4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double‐blind, non‐inferiority trial. Diabetes, Obes Metab. 2007 Mar;9(2):194-205.

Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007 Jul 11;298(2):194-206.

Arechavaleta R, Seck T, Chen Y. Efficacy and safety of treatment with sitagliptin orglimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: arandomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011;13(2):160-8.