Journal of Diabetes Mellitus, 2016, 6, 38-48 Published Online February 2016 in SciRes. http://www.scirp.org/journal/jdm http://dx.doi.org/10.4236/jdm.2016.61005 How to cite this paper: Suthar, A.C., et al. (2016) 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. Jour- nal of Diabetes Mellitus, 6, 38-48. http://dx.doi.org/10.4236/jdm.2016.61005 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 Ashish C. Suthar 1* , Vikas G. Pai 2 , Yogesh Kadam 3 , Aniruddha Tongaonkar 4 , Shailaja Kale 5 , Atul B. Deshpande 6 , Sharat Kolke 7 , Snehal Tanna 8 , Shrikant V. Deshpande 9 , Purvi Chawla 1 , Debjit Biswas 1 , Somesh Sharma 1 1 Piramal Enterprises Limited, Mumbai, India 2 Pai Clinic and Diagnostic Center, Pune, India 3 Poona Diabetes Centre, Pune, India 4 Tongaonkar Hospital, Pune, India 5 Orange Diabetes Clinical Research Unit, Pune, India 6 Ethika Clinical Research Centre Prakruti Hospital, Thane, India 7 Kolkes Clinic, Mumbai, India 8 Clinic De Care, Thane, India 9 Ashirwad Hospital and Medical Research Centre, Thane, India Received 30 December 2015; accepted 29 January 2016; published 4 February 2016 Copyright © 2016 by authors and Scientific Research Publishing Inc. This work is licensed under the Creative Commons Attribution International License (CC BY). http://creativecommons.org/licenses/by/4.0/ 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 * Corresponding author.