ABSTRACT
Objective: To assess the safety and efficacy of herbal formulation rich in standardized fenugreek seed extract (IND-2) add-on therapy in type 2 diabetes mellitus (T2DM) patients who were on insulin treatment in prospective, single arm, open-label, uncontrolled, multicentre trial. Methods: T2DM patients (n=30) with aged 18-80 years who were stabilized on insulin treatment with fasting blood sugar (FBS) level between 100-140 mg/dL received IND-2 capsules (700 mg, thrice a day) for 16 weeks. The primary endpoints were an assessment of FBS at week 2, 4, 6, 8, 12 and 16. Secondary end-points include post-prandial blood sugar level, glycosylated Hb (HbA1c), reduction in the dose of insulin and number of hypoglycemic attacks, and improvement in lipid profile at various weeks. Safety and adverse events (AEs) were also assessed during the study. Results: Study was completed in twenty T2DM patients, and there was no significant reduction in FBS and post-prandial blood sugar level after addon therapy of IND-2. However, add-on therapy of IND-2 significantly reduced (P<0.01) the HbA1c values, requirements of insulin and hypoglycemic events as compared with baseline. Total cholesterol, high-density lipoproteins-cholesterol, and low-density lipoproteincholesterol levels were significantly increased (P<0.01) after IND-2 add-on therapy. Body weight and safety outcomes did not differ significantly in IND-2 add-on therapy group at week 16. Additionally, add-on therapy of IND-2 did not produce any serious adverse events. Conclusions: The results of present investigation suggest that add-on therapy of IND-2 with insulin in T2DM patients improves glycaemic control through a decrease in levels of HbA1c and number of insulin doses needed per day without an increase in body weight and risk of hypoglycemia. Thus, IND-2 may provide a safe and well-tolerated add-on therapy option for the management of T2DM.
ABSTRACT
The antihyperglycaemic activity of IND 01 and its interaction with glyburide and pioglitazone on serum glucose, body weight and oral glucose tolerance test [OGTT] was determined in alloxan-induced diabetic mice. IND 01 [100 mg/kg], glyburide [10 mg/kg], pioglitzone [10 mg/kg] and their concomitant administration were administered orally in alloxan [80 mg/kg, i.v.] induced diabetic mice. The study design consisted of estimation of serum glucose after acute, subacute and glucose load administration. Administration of IND 01 [100 mg/kg] alone significantly [p<0.001] reduced serum glucose level at 6 h after administration. The antihyperglycaemic effect of glyburide and their concomitant administration of IND 01 with glyburide were similar, that is, onset was 2 h; peak effect was 6 h but the effect waned at 24 h. The onset of concomitant administration of IND 01 with pioglitazone was 4 h; peak effect was at 6 h but the effect waned at 24 h. In the subacute study, reduction in serum glucose was observed on 28[th] day after withdrawal for 7 days. The effects of concomitant administration were more pronounced than single drug treatment. In mice treated with either IND 01 [100 mg/kg], glyburide, pioglitazone alone or their combination, the body weight was not reduced in contrast to that in the control group. In the oral glucose tolerance test [OGTT], increased glucose utilization was observed in animals after concomitant administration of IND 01 [100 mg/kg] and glyburide [10 mg/kg] as well as IND 01 [100 mg/kg] and pioglitazone [10 mg/kg]. The concomitant administration of IND 01 with glyburide as well as pioglitzone produced synergistic antihyperglycaemic effect than either drug alone