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 non-significant 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). High-density 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.