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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

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Journal of Diabetes Mellitus 2016年第1期6卷 38-48页

作者： 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 Piramal Enterprises Limited Mumbai India Pai Clinic and Diagnostic Center Pune India Poona Diabetes Centre Pune India Tongaonkar Hospital Pune India Orange Diabetes Clinical Research Unit Pune India Ethika Clinical Research Centre Prakruti Hospital Thane India Kolkes Clinic Mumbai India Clinic De Care Thane India Ashirwad Hospital and Medical Research Centre Thane India

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.

关键词： Momoradica charantia glycebal Diabetes mellitus Anti-Diabetic

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