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.
Background: India is the world’s diabetic capital. Oral antidiabetic therapy is still incomplete. Prior studies have shown that hydroxychloroquine (HCQ), a commonly used antimalarial, anti-rheumatic drug reduces the risk of developing diabetes mellitus. It probably acts by decreasing insulin metabolism- a novel mechanism of action.Methods: A systematic search was done in MEDLINE database with key words ‘Type 2 Diabetes Mellitus’, ‘Hydroxychloroquine’. Articles assessing the antidiabetic efficacy of hydroxychloroquine were reviewed and their results summarized.Results: With extensive literature search, we found out three RCTs and four Cohort studies assessing the efficacy of HCQ on glycaemic markers in patients with type 2 diabetes mellitus. Two randomized controlled trials done by Gerstein H C et al, Pareek A et al, comparing hydroxychloroquine with established antidiabetic drugs showed that there is significant reduction in glycaemic parameters with comparable similarity in both the groups (HbA1c: -0.91%±0.4%). Solomon et al in their study on patients with RA concluded that HCQ improved insulin sensitivity. Two cohort studies by Chen Y M et al and Wasko MCM et al respectively showed reduced incidence of diabetes mellitus in Systemic lupus erythematosus (Hazard ratio=0.26) and rheumatologic disease (relative risk=0.23) patients who received hydroxychloroquine. In a cohort study by Rekedal LR et al, HCQ reduced HbA1c by 0.66% compared to baseline in patients with RA. These studies also showed that hydroxychloroquine has favourable effect on lipid profile and good tolerabilityConclusions: Hydroxychloroquine has a potential to enter antidiabetic armamentarium due to its efficacy and low toxicity profile. More studies are required to confirm this.
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