Complete title of the manuscript: Efficacy and Safety of Resveratrol as an Adjuvant Therapy in Type 2 Diabetes Mellitus Patients: Result of a Randomized Active Controlled Clinical Study
Journal Title: International Journal Of Research In Medicine - Year 2016, Vol 5, Issue 4
Abstract
BACKGROUND: No long term clinical efficacy and safety study of resveratrol as adjuvant therapy along with gold standard therapy has been conducted in type 2 diabetes mellitus (T2DM). The aim of this study was to investigate the efficacy and safety of resveratrol as an adjuvant therapy in newly diagnosed T2DM patients. METHODS: In this randomized active-controlled study, T2DM patients (male/female) aged 20-65 years were randomized to receive glimepiride 2mg or glimepiride 2mg plus resveratrol 1 gram daily for 12 months. Efficacy variables included change in plasma blood glucose (fasting and postprandial) and glycosylated hemoglobin (HbA1c) from baseline and were followed-up for every 3 months. Treatment-emergent adverse events (TEAEs) were assessed. RESULTS: A total of 60 T2DM patients were analyzed (glimepiride [n=30] and glimepiride plus resveratrol [n=30]). Resveratrol as an adjuvant with glimepiride significantly reduced plasma blood glucose concentration as compared to glimepiride monotherapy during fasting and postprandial conditions (p<0.001). Mean levels of HbA1c were significantly lower in glimepiride plus resveratrol group than glimepiride (p<0.001). Both the study drugs have similar safety profile, and found well tolerable. CONCLUSIONS: Resveratrol plus glimepiride was found to be superior over glimepiride monotherapy in reducing plasma blood glucose concentration (fasting and fed) and significantly improve glycemic control by reducing HbA1c levels in patients with T2DM. Both the study drugs were effective with comparable safety profile. Our study supports the long term clinical efficacy and safety study of resveratrol along with gold standard therapy in T2DM.
Authors and Affiliations
Ojha Rakesh, Kulkarni Pranesh, Vyas Bhavin
Keywords
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