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 thera py 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 hy poglycemic treatment were screened. The eligible 85 subjects were randomized into 3:1 ratio in drug treatment (PDM011011 capsules) and placebo arm. Sixtyfour 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 HbA 1c % from baseline to day 30, 60 and 90 after interventions. Results. PDM011011capsule (1.2 g/day) showed sig nificant 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 reduc tion in HbA 1c % 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, seri ous adverse events and death in the study population. Conclusion. PDM011011capsule (1.2 g/day) showed good efficacy and safety; and it can be prescribed as an adjuvant therapy in subjects with T2DM.

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

“…Momordica charantia significantly reduced HbA1c (−0.3%; −0.4 to −0.1), FBG (−14 mg/dl; −23 to −4), PPBG (−26 mg/dl; −47 to −4), and fasting insulin (as insulin sensitizer; −13 mIU/L; −16 to −10) (see Figure 22 ). ( Dans et al, 2007 ; Zänker et al, 2012 ; Trakoon-osot et al, 2013 ; Suthar et al, 2016a ; Cortez-Navarrete et al, 2018 ; Kumari et al, 2018 ; Amini et al, 2020 ; Kim et al, 2020 ) In the country subgroup analysis for HbA1c and FBG, no statistically significant difference was found between subgroups ( p = 0.25 and p = 0.14, respectively).…”

Effects of Momordica charantia L. supplementation on glycemic control and lipid profile in type 2 diabetes mellitus patients: A systematic review and meta-analysis of randomized controlled trials

“…The eight studies included in this analysis were published from 2003 to 2022 [ [17] , [18] , [19] , [29] , [30] , [31] , [32] , [33] ]. Among these, seven studies were conducted in Asia [ [17] , [18] , [19] , [29] , [30] , [31] , 33 ], while one study was conducted in North America [ 32 ]. One study [ 30 ] followed an open-label, randomized, active-controlled, phase II trial.…”

“…Among these, seven studies were conducted in Asia [ [17] , [18] , [19] , [29] , [30] , [31] , 33 ], while one study was conducted in North America [ 32 ]. One study [ 30 ] followed an open-label, randomized, active-controlled, phase II trial. One study [ 31 ] was a single-blind RCT, while the remaining seven studies [ [17] , [18] , [19] , 29 , 30 , 32 , 33 ] were double-blind RCTs.…”

“…One study [ 30 ] followed an open-label, randomized, active-controlled, phase II trial. One study [ 31 ] was a single-blind RCT, while the remaining seven studies [ [17] , [18] , [19] , 29 , 30 , 32 , 33 ] were double-blind RCTs. The eight included studies were conducted with both genders, and the total sample size was 423.…”

D-optimal mixture design optimized solid formulation containing fruits extracts of Momordica charantia and Abelmoschus esculentus

“…For example, Suthar et al, 2016 used a patented juice preparation procedure (not disclosed) to make juice using whole fruits of M. charantia. Then developed PDM011011-capsule contained 400 mg of dry standardized fruit juice powder with not less than 0.4 mg of Uridine as a chemical marker [59]. Similarly, an Ayurvedic formulation Gluco-Care capsules manufactured by The Himalaya Drug Company, Bengaluru, India, used M. charantia fruit extract combined with 22 extracts from different plant species [60].…”