TITLE:
Efficacy and Safety of PDM011011 Capsules as Compared to Metformin in Subjects with Type-2 Diabetes Mellitus: An Open-Label, Randomized, Active-Controlled, Multicentric, Phase III Study
AUTHORS:
Ashish C. Suthar, Vikas G. Pai, Yogesh Kadam, Aniruddha Tongaonkar, Shailaja Kale, Atul B. Deshpande, Sharat Kolke, Snehal Tanna, Shrikant V. Deshpande, Purvi Chawla, Debjit Biswas, Somesh Sharma
KEYWORDS:
Momoradica charantia, Glycebal, Diabetes mellitus, Anti-Diabetic
JOURNAL NAME:
Journal of Diabetes Mellitus,
Vol.6 No.1,
February
4,
2016
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.