Efficacy and safety of Glycebal (PDM011011) capsules as adjuvant therapy in subjects with type 2 diabetes mellitus: An open label, randomized, active controlled, phase II trial

Abstract

Background. Momordica charantia is a medicinal plant used traditionally for treatment of various diseases including diabetes. Objective. To evaluate the efficacy and safety of PDM011011 capsules (1.2 g/day) as an adjuvant therapy in subjects with type 2 diabetes mellitus (T2DM). Methods. Each PDM011011 capsule contained 400 mg dry fruit juice powder of Momordica charantia. Ninety three T2DM patients receiving at least one oral hypoglycemic treatment were screened. The eligible 85 subjects were randomized into 3:1 ratio in drug treatment (PDM011011 capsules) and placebo arm. Sixty-four patients received three 400 mg PDM011011 capsules (1.2 g/day) while 21 patients received three placebo capsules per day for 90 days respectively. The primary efficacy endpoints were mean change in FPG, PPG level and HbA1c% from baseline to day 30, 60 and 90 after interventions. Results. PDM011011-capsule (1.2 g/day) showed significant reduction in FPG level by 14.59% after 90 days treatment, while patients receiving placebo capsules exhibited a marginal increase of 2.12%. The reduction in FPG level was statistically significant (p = 0.013) as compared with the placebo group. It also reduced PPG level by 22.21% as compared to the 3.71% reduction (p = 0.002) in placebo group. The encouraging reduction in HbA1c% in the drug group was 0.78 as compared to the placebo group with only 0.20 (p = 0.066). PDM011011 capsule showed no adverse events, serious adverse events and death in the study population. Conclusion. PDM011011-capsule (1.2 g/day) showed good efficacy and safety; and it can be prescribed as an adjuvant therapy in subjects with T2DM.