Evaluation of Efficacy and Tolerability of Fixed Dose Combination of Metformin with Voglibose Versus Metformin with Pioglitazone in Prediabetics: An Open label, prospective, RCT
Abstract
Background: ADA has cut-off value for IGT (140-200 mg/dL) but has a lower cut-off value for IFG (100-125 mg/dL) and has additional hemoglobin A1c (HbA1c) based criteria of a level of 5.7% to 6.4% for the definition of prediabetes. Due to progressive nature of prediabetes, dual drug therapy produces additive effects, allows the use of submaximal doses, and less side effects of individual agents. Therefore, the present study was designed to study the effect of voglibose in comparison to pioglitazone on glycemic control as an add-on drug in prediabetes patients whose glycemic status was uncontrolled with metformin alone.
Methods: The present study was open, randomized, parallel group comparison of two active treatment groups over a period of six months. Sixty-seven patients of either sex in the age group of 30-60 years, suffering from prediabetes, with FBG: 100-125 mg/dl and PPBG:140-200 mg/dl as per ADA were selected at randomly. The effect of FDC of Voglibose with Metformin and Pioglitazone with Metformin were observed on various parameters of Glycemic Triad (FBG, PPBG, HOMA-IR, HbA1c and Serum Insulin).
Results: At the end of 6 months it was observed that though both FDC of Voglibose with Metformin and Pioglitazone with Metformin reduced Glycaemia Statistically significantly but Pioglitazone with Metformin caused a significantly greater percentage change in Glycaemia as compared with Voglibose with Metformin. Few side effects were observed with Voglibose but not with Pioglitazone.
Conclusions: Though Voglibose with Metformin and Pioglitazone with Metformin were equally effective in lowering Glycemia yet Pioglitazone with Metformin showed better results in improving glycaemia, as compared to Voglibose with Metformin. Pioglitazone with Metformin had minimal side effects as compared to Voglibose with Metformin.
Keywords: Voglibose, Metformin, Pioglitazone, Prediabetes, Glycemia
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