Abstract

COMPARISON OF THERAPEUTIC OUTCOME OF ORAL ANTIDIABETIC FDCs GLIMEPIRIDE WITH METFORMIN VS VILDAGLIPTIN WITH METFORMIN: A PROSPECTIVE STUDY IN TYPE – II DIABETES MELLITUS PATIENTS

Megha Patel*, Vishal Chudasama, Kiran Suthar, Bharat Rajpurohit

ABSTRACT

Background: Type 2 diabetes is often referred to as non–insulin-dependent diabetes mellitus (NIDDM). In type 2 diabetes, the insulin secretory response is impaired—increasingly so as the disease progresses with time, but in most cases, a comorbid defect is the failure of many cells of the body to properly respond to circulating insulin, particularly certain cells in the liver and skeletal muscles having a primary glucose storage role, and certain cells in adipose tissue. Yet no cure is available, education of populace is still the key to control this emerging epidemic. Type 2 diabetes has most often been treated with various drugs as monotherapy or in combination of either drugs acting by other mechanism or Insulin effective glycemic control. Biguanides monotherapy or its combination with dipeptidyl peptidase-4 inhibitor/sulphonyl urea is a preferred therapy due to better efficacyand safety. Objective: The objective of this study was to assess and compare the efficacy and safety of the combination Metformin with Glimepiride Vs Vildagliptin in type-2 diabetes mellitus patients. Method: This was an observational, prospective and open labelled study in which Glimepiride-Metformin combination was compared with Vildagliptin-Metformin combination in patients aged between 30-65 years having HbA1c >7. Patients were prescribed either of these combinations and were respectively assigned to one of the two groups. The efficacy end points included changes in FBFBGG and PPBG at 4, 8 and 12 weeks of treatment. Other efficacy end points include changes in HbA1c and BMI at 12 weeks of treatment. The safety of the treatment was also evaluated based on adverse effects during the 12 weeks treatment period. Results: A total of 115 patients accessed for study, 11 patients were excluded so 104 patients were enrolled in the study. 4 patients were lost to follow up, two from each treatment group. After 12 weeks of treatment, percentage reduction from baseline in FBG, PPBG and HbA1c for Glimepiride-Metformin treated group was 31.12 %, .31.45% and 16.10 % respectively, while for Vildagliptin-Metformin treated group it was 31.86 %, 32.57 % and 15.63% respectively. After 12 weeks of treatment the BMI increased slightly in Glimepiride-Metformin group, while it decreased slightly in Vildagliptin-Metformin group from baseline, however there was not significant. In regard to adverse effects, higher number of hypoglycaemic events were observed in Glimepiride-Metformin treated groups compared to Vildagliptin-Metformin treated group. Conclusion: The results of this study demonstrated that both the combination therapies were successful in reducing the blood glucose significantly and on comparison revealed similar efficacy level thereby failing to prove the superiority over each other. However, the incidence of hypoglycaemia and other adverse events were numerically more in Group-I (Glimeperide+Metformin). Also, Group-II (Vildagliptin+Metformin) combination had good safety profile with low risk of hypoglycaemia and weight gain as compared to Group-1(Glimeperide+Metformin) combination.

Keywords: Type II Diabetes mellitus, metformin, Glimepiride, Vildagliptin, Blood glucose, HbA1c, adverse effect.