Corpus ID: 45078607

Efficacy and Safety of PDM 011011 Capsules as Compared to Metformin in Subjects with Type-2 Diabetes Mellitus : An Open-Label , Randomized , Active-Controlled , Multicentric , Phase III Study

  title={Efficacy and Safety of PDM 011011 Capsules as Compared to Metformin in Subjects with Type-2 Diabetes Mellitus : An Open-Label , Randomized , Active-Controlled , Multicentric , Phase III Study},
  author={Ashish C. Suthar and Vikas G. Pai and Yogesh Kadam and Aniruddha Tongaonkar and Shailaja D Kale and Atul B. Deshpande and Sharat Kolke and Snehal Tanna and Shrikant Deshpande and Purvi M. Chawla and Debjit Biswas and Somesh D. Sharma},
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. 

Figures and Tables from this paper


Hypoglycemic effect of bitter melon compared with metformin in newly diagnosed type 2 diabetes patients.
Bitter melon had a modest hypoglycemic effect and significantly reduced fructosamine levels from baseline among patients with type 2 diabetes who received 2,000 mg/day, however, the hypogly diabetic effect of bitter melon was less than metformin 1,000mg/day. Expand
The effect of Momordica charantia capsule preparation on glycemic control in type 2 diabetes mellitus needs further studies.
This is the first randomized controlled trial to shed light on the issue concerning the hypoglycemic effects of M. charantia and the results can be used to estimate the sample size for bigger studies. Expand
The evaluation of risk factors associated with adverse drug reactions by metformin in type 2 diabetes mellitus.
The optimization of the dose of metformin by considering risk factors would be beneficial for patients with T2DM in order to avoid ADRs, especially diarrhea, subsequently improving the quality of life during meetformin use. Expand
Oral Hypoglycemic Drugs: Pathophysiological Basis of Their Mechanism of Action
There are seven distinct classes of anti-hyperglicemic agents, each of them displaying unique pharmacologic properties, and the aim of this review is to describe the pathophysiological basis of their mechanism of action. Expand
Lower hypoglycemic but higher antiatherogenic effects of bitter melon than glibenclamide in type 2 diabetic patients
Bitter melon has a weaker hypoglycemic effect but ameliorates the diabetes associated cardiovascular (CV) risk factors more effectively than glibenclamide. Expand
Alternative therapies useful in the management of diabetes: A systematic review
Alternative therapies such as dietary supplements, acupuncture, hydrotherapy, and yoga therapies less likely to have the side effects of conventional approaches for diabetes. Expand
The hypoglycemic effect of Juglans regia leaves aqueous extract in diabetic patients: A first human trial
The results indicate that J. regia aqueous extract favorably affects blood levels of glucose, insulin and HbA1C in type 2 diabetic patients. Expand
Bitter Melon (Momordica Charantia) Reduces Serum Sialic Acid in Type2 Diabetics: Evidence to Delay the Process of Atherosclerosis
The study provides another mechanism for the cardioprotective effect of bitter melon and further strengthens its value in the management of type2 diabetes. Expand
Relation of fasting and postprandial and plasma glucose with hemoglobinA1c in diabetics
The postprandial (after breakfast) plasma glucose has closer association to glycosylated hemoglobin than fasting plasma glucose, therefore evaluating postpr andial plasma glucose should be the focus. Expand
Antidiabetic effects of Momordica charantia (bitter melon) and its medicinal potency
The present review is an attempt to highlight the antidiabetic activity as well as phytochemical and pharmacological reports on M. charantia and calls for better-designed clinical trials to further elucidate its possible therapeutic effects on diabetes. Expand