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Comparison of Safety and Efficacy of Glimepiride-Metformin and Vildagliptin- Metformin Treatment in Newly Diagnosed Type 2 Diabetic Patients.

Objectives
To compare the safety and efficacy of combination of Glimepiride - Metformin with Vildagliptin - Metformin in type 2 diabetic patients with HbA1c between 7.5to10.


Methods
A randomized, prospective, comparative and interventional study was conducted at Indira Gandhi Medical College, Shimla. The level of hemoglobin A1c (HbA1c), fasting blood sugar (FBS) and postprandial blood sugar (PP) were the primary outcomes, whereas, the evidence of hypoglycemia, quality of life and weight gain were recorded as secondary outcomes. 215 patients newly diagnosed with type 2 diabetes mellitus were randomized into Glimepiride-Metformin group (Group1) having 111 patients and Vildagliptin-Metformin group (Group 2) having 106 patients. Patients were followed up at 3 month, 12 month, 24 month and then after completion of 30 month of treatment.


Results
A comparable FPG, PPPG and HbA1c were observed from baseline at the end of 12 weeks in both groups. However, at the 130-week endpoint a significantly more pronounced reduction in HbA1c was observed in vildagliptin-metformin (1.96%) arm compared to Glimepiride-metformin (1.67%) arm. A similar significant more pronounced reduction was demonstrated in both FPG (48.25% vs. 41.70%) and PPPG (49.40% vs. 42.95%) in vildagliptin-metformin group compared to Glimepiride-metformin group. The proportion of patients who achieved an A1C < 7% at 130-weeks was 49% in the vildagliptin group and 41% in the Glimepiride group. Statistically significant more weight gain was observed in Glimepiride arm compared to vildagliptin arm (2.09 kg vs. 0.69 kg) and 8-fold lower incidence was observed in vildagliptin group. Conclusion: Vildagliptin -metformin represent a more effective combination in terms of number of patients achieving guidelines recommended A1C target of less than 7% at the end of 30 months, less weight gain, and a lower risk of hypoglycemia in newly diagnosed type 2 diabetic patients with moderate hypoglycemia.


Conclusions
Vildagliptin -metformin represent a more effective combination in terms of number of patients achieving guidelines recommended A1C target of less than 7% at the end of 30 months, less weight gain, and a lower risk of hypoglycemia in newly diagnosed type 2 diabetic patients with moderate hypoglycemia.