Anti‐Diabetic Efficacy of a Novel Fenugreek Seed (Trigonella foenum‐graecum, Fenfuro) Extract in Patients with Type‐2 Diabetes

Abstract

Fenugreek seeds are known to exhibit potent antioxidant, hypoglycemic and nephroprotective activities. Previous studies in our laboratories demonstrated the broad spectrum safety and efficacy of Fenfuro, a novel Trigonella foenum‐graecum seed extract enriched in furostanolic saponins, in type 2 diabetes (T2D) in rats. We conducted a multi‐center, randomized, placebo‐controlled, double‐blind, add‐on clinical study evaluated over a period of 3 months the efficacy of Fenfuro (500 mg bid) in 154 male and female subjects (25–60 years) with T2D. This study examined the body weight, blood pressure and pulse rate, as well as the efficacy of Fenfuro on fasting and post‐prandial plasma sugar, HbA1c and fasting and post‐prandial C‐peptide levels. Fenfuro caused significant reduction in both fasting plasma and post‐prandial blood sugar levels. Approximately 83% of the subjects reported decrease in fasting plasma sugar levels in the Fenfuro group as compared to 62% in the placebo group, while 89% of the subjects demonstrated reduction in post‐prandial plasma sugar levels in the Fenfuro‐treated group as compared to 72% in the placebo group. HbA1c levels were reduced in both placebo and treatment groups. The decrease in HbA1c levels was significant in both groups as compared to respective baseline values. A significant increase in fasting and post‐prandial C‐peptide levels compared to the respective baseline values, were observed, while no significant changes in fasting and post‐prandial C‐peptide levels were observed between the two groups. Extensive blood chemistry analyses exhibited the broad spectrum safety of Fenfuro. Furthermore, 48.8% subjects reported reduced dosage of anti‐diabetic therapy in Fenfuro‐treated group, while 18.05% reported reduced dosage of anti‐diabetic therapy in the placebo‐group. Overall, Fenfuro proved safe and efficacious in ameliorating the symptoms of T2D in humans.Support or Funding InformationStudy Supported by Cepham Research Center, Piscataway, NJ, USA