Comparative evaluation of glipizide and fenugreek (Trigonella foenum-graecum) seeds as monotherapy and combination therapy on glycaemic control and lipid profile in patients with type 2 diabetes mellitus

Abstract

Background: Diabetes is commonly associated with dyslipidemia, which is one of the major risk factors of coronary heart disease (CHD), the leading cause of mortality in patients with type 2 diabetic. It is thus desirable that an anti-diabetic drug must provide good glycaemic control and in addition cause correction of dyslipidaemia, at the same time being safe. Fenugreek, a traditional drug has been found to have beneficial effect on glycaemic control as well as lipid profile and may be thus useful in such patients. The study was thus planned to further explore the effect of fenugreek seed on glycaemic control and lipid profile by comparing it with a standard anti-diabetic drug glipizide. Methods: This 12 week, prospective, randomized, open-label, parallel group comparative study was conducted on 60 patients with type 2 diabetes. The patients were randomized to receive either glipizide 5 mg once daily (group A, n=20), fenugreek seed extract 500 mg twice a day (group B, n=20), or a combination of glipizide 2.5 mg and fenugreek seed extract 500 mg once daily (group C, n=20). The primary endpoint were the change in fasting blood glucose (FBG), glycated haemoglobin (HbA1c), and lipid profile from baseline after 12 weeks of treatment. Results: A statistically significant decline in mean FBG levels (group A -33.97%, p<0.001; versus group B -24.62%, p<0.001; versus group C -29.96%, p<0.001), and in HbA1c levels (group A -12.98 %, p<0.0001; group B -9.38%, p<0.0001; and group C -10.62%, p<0.0001) was seen in all three treatment groups. Total cholesterol (TC) reduced non-significantly in group A (-0.98%, p=0.1982), whereas in group B (-5.66%, p<0.001) and group C (-3.87%, p<0.001) it decreased significantly. Non-significant reduction in plasma triglycerides (TG) were seen in group A (-0.74%, p=0.0669), and significant reductions were seen in both group B (-17.23%, p<0.001) and group C (-11.34%, p<0.001). Low density lipoproteins cholesterol (LDL-C) showed nonsignificant reductions in group A (-0.74%, p=0.5482), and significant reductions in both group B (-4.15%, p<0.001) and group C (-2.68%, p=0.0463). Highdensity lipoproteins cholesterol (HDL-C) showed non-significant changes in all three groups (group A -0.60%, p =0.1529; group B 0.65%, p=0.2072; and group C 0.76%, p = 0.0543). The adverse drug reactions seen were mild in nature and none of the patients was withdrawn from the study because of serious adverse drug reactions. Conclusions: Monotherapy with fenugreek produced significant improvement in glycaemic control and dyslipidaemia. Glipizide monotherapy was more efficacious in controlling FBG and HbA1c levels than fenugreek monotherapy or in combination with fenugreek; glipizide monotherapy had no effect on lipid profile whereas fenugreek monotherapy was more efficacious in controlling dyslipidaemia than in combination with glipizide. Both drugs as monotherapy or in combination were well-tolerated by the patients.

Effectiveness and Safety of Ayurvedic Medicines in Type 2 Diabetes Mellitus Management: A Systematic Review and Meta-Analysis

“…Trigonella foenum-graecum significantly reduced HbA1c (−0.6%; −0.9 to −0.4), FBG (−14 mg/dl; −22 to −5), PPBG (−21 mg/dl; −34 to −7), stimulated insulin (as insulin sensitizer; −21 mIU/L; −36 to −5), fasting C-peptide (as insulin sensitizer; −0.41 ng/ml; −0.67 to −0.16), BMI (−0.6 kg/m 2 ; −1.1 to −0.1), waist circumference (−4 cm; −7 to −1), and TG (−23 mg/dl; −46 to −1), and increased stimulated C-peptide (as insulin sensitizer; 0.93 ng/ml; 0.09–1.77) (see Figure 33 ). ( Gupta et al, 2001 ; Lu et al, 2008 ; Yaheya and Ismail, 2009 ; Ansari et al, 2011 ; Rafraf et al, 2014 ; Suchitra and Parthasarathy, 2015 ; Kaur et al, 2016 ; Singh et al, 2016 ; Verma et al, 2016 ; Ranade and Mudgalkar, 2017 ; Gholaman and Gholami, 2018 ; Kandhare et al, 2018 ; Hassani et al, 2019 ; Hota et al, 2019 ; Rashid et al, 2019 ; Hadi et al, 2020 ) Publication bias was detected in the funnel plot for HbA1c but not for FBG. In the funnel plot for HbA1c, there was an absence of smaller sized studies showing a larger positive effect, which could imply the effect may be larger than that reported from the meta-analysis.…”

“…Figure 34 shows the summary forest plot for Trigonella foenum-graecum (versus OAD). ( Singh et al, 2016 ; Najdi et al, 2019 ).…”

Some Common Medicinal Plants with Antidiabetic Activity, Known and Available in Europe (A Mini-Review)

“…In clinical trials, on the other hand, consumption of Trigonella seed extract, enriched in 40% of furostanolic saponins for 30, 60, and 90 days, resulted in a 6.69%, 10.31%, and 21.98% reduction of FBG, respectively, a 13.7%, 20.6%, and 30.4% reduction in postprandial blood glucose levels, and a reduction in glycosylated hemoglobin levels (but not significant) [119]. In studies by Singh et al [120], 20 patients with type 2 diabetes took 5 mg of glipizide per day (Group A) for 12 weeks, 20 patients took 500 mg of fenugreek seed extract twice a day (Group B), and 20 patients took 2.5 mg of glipizide + 500 mg of fenugreek seed extract per day (Group C). In all groups, a significant decrease in FBG (A-33.97% > C-29.96% > B-24.62%) and glycated hemoglobin (A-12.98% > C-10.62% > B-9.38%) was observed; in Groups B and C, a significant decrease in TC (respectively: −5.66% and −3.87%), plasma triglycerides (−17.23% and −11.34%, respectively) and LDL cholesterol (−4.15% and −2.68%, respectively) could be noted.…”

Treatment on Nature’s lap: Use of herbal products in the management of hyperglycemia

“…The human trial showed a decrease in FBS range from 15 to 41 mg/dL, a decrease in HbA1C from 0.2% to 1.46% and HOMA-IR from 0.44 to 0.68. Singh et al [ 31 ] from India compared 500 mg fenugreek with 5 mg glipizide in 60 diabetes patients. The patients were randomized into three groups.…”