Abstract
Context: Bitter melon (Momoradica charantia) is one of the well-known plants used for lowering blood glucose since antiquity. Aims: To compare the efficacy and safety of PDM011011 capsule (1200 mg/day) with Metformin (1000 mg/day) in a 15 weeks study using mean change in fasting plasma glucose (FPG) and Hb1Ac% in subjects with type 2 diabetes mellitus (T2DM). Settings and Design: This is an open-label, randomized, active-controlled, multicentric, phase III study. Methods and Material: A total of 123 eligible patients were randomized in 2:1 ratio in PDM011011 and Metformin arm. Total 83 subjects received PDM011011 capsule (1200 mg/day) and 40 subjects received Metformin (1000 mg/day) in their respective arms for 15 weeks. Subjects were analyzed for FPG and Hb1Ac% at baseline and during treatment visits (Visit 3 to Visit 7). Safety assessments were carried out. Results: In this study, the significant reduction in mean FPG level was observed after treatment with PDM011011 capsule and Metformin in T2DM patients. The mean change from baseline to week 15 in FPG was 14.52 mg/dL (95% CI: 6.36, 22.67) in the PDM011011-treated subjects and 28.34 mg/dL (95% CI: 21.35, 35.32) in the Metformin-treated subjects. At week 15, the mean change from baseline in HbA1c levels was 0.27% (95% CI: 0.06, 0.47) in the PDM011011 arm and 0.62% (95% CI: 0.40, 0.83) in the Metformin arm. Conclusion: PDM011011 capsule (1200 mg/day) exhibited the modest efficacy and safety as compared to Metformin (1000 mg/day) in type 2 diabetes patients.
Highlights
Diabetes mellitus is a chronic metabolic disorder having multiple etiologies, characterized by hyperglycemia resulting from defective insulin secretion, resistance to insulin action, or a combination of both [1] [2]
The eligible subjects were randomized in 2:1 ratio and received either PDM011011 capsule (N = 83) or Metformin tablet (N = 40)
Two subjects in PDM011011 arm discontinued for safety reasons as judged by the investigator and/or sponsor, due to the withdrawal criteria being met
Summary
Diabetes mellitus is a chronic metabolic disorder having multiple etiologies, characterized by hyperglycemia resulting from defective insulin secretion, resistance to insulin action, or a combination of both [1] [2]. Diabetes leads to 1.5 million deaths worldwide in 2012 and is the seventh leading global cause of death [4]. Blindness, amputations are the prominent microvascular complications of diabetes. Macrovascular complications affect the cardiovascular system manifesting myocardial infarction and strokes [5]. Pathophysiological conditions in Type 2 Diabetes mellitus (T2DM) are due to impaired insulin secretion by pancreatic β cells and insulin resistance or both [6]. T2DM can be treated with metformin, insulin secretagogues, DPP-4 inhibitors, GLP-1 mimetic, acarbose and insulin [7]. For the management of T2DM, it is essential that treatment should improve glycemic control with no or least adverse effects [8]
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