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ARTICLE | Clinical News

Tradjenta: Interim Phase III data

June 25, 2012 7:00 AM UTC

Interim data from a double-blind Phase III trial in 1,261 Type II diabetics inadequately controlled on basal insulin therapy with or without metformin and/or Actos pioglitazone showed that once-daily 5 mg Tradjenta as an add-on therapy met the primary endpoint of reducing HbA1c from baseline to week 24 vs. placebo (mean placebo-adjusted reduction in HbA1c of 0.65%, p<0.0001). Tradjenta also non-significantly reduced mean body weight by 0.17 kg vs. an increase of 0.13 kg for placebo (p=0.07). Hypoglycemia occurred in 25.7% of patients receiving Tradjenta vs. 27.3% for placebo. Data were presented at the American Diabetes Association meeting in Philadelphia. ...