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Diabetes Compound from Dr. Reddy’s Found Successful in Phase III Study
The study was a randomized, double blind, parallel-group placebo- and active comparator-controlled clinical study to determine how effective and safe the diabetic compound Balaglitazone was, in usage. The study explored the impact of adding placebo, Balaglitazone 10mg, Balaglitazone 20mg or Pioglitazone 45mg to a background treatment regimen of stable insulin therapy for a period of 26 weeks. While the primary endpoint was HbA1c reduction, there were various secondary endpoints including fasting plasma glucose, edema, weight gain, and body composition.
The study had 409 patients randomized in roughly equal proportions across the four arms of the study. All three active arms (Balaglitazone 10mg, 20mg and Pioglitazone 45mg) showed levels of efficacy that were alike for HbA1c and fasting plasma glucose.
All three active arms demonstrated good tolerability and adverse event profile, with Balaglitazone 10mg showing less water retention, less fat accumulation, lower weight/BMI gain and less bone loss in comparison to the Pioglitazone arm. Adverse events were similar in number across the three active arms, with adverse events of special interest such as bone fracture, hematuria, heart failure, cardiac ischemia, oedema, weight gain, being less in number in the Balaglitazone 10mg group compared to Pioglitazone 45mg.
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kinggill(Guest)
01/06/2010
I am diabetic from 18 years and more - excersice jogging and diet intake made me live that long- how this will help someone like me . please be very clear
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