12:00 AM
Jun 15, 2009
 |  BioCentury  |  Product Development

Differentiating the DPP-4 Space

By the time linagliptin from Boehringer Ingelheim GmbH reaches the market for Type II diabetes, competing DPP-4 inhibitor Januvia sitagliptin will have at least a four-year head start. But Boehringer Ingelheim thinks it will be able to compete based on ease of use in a subgroup of diabetic patients with renal insufficiency.

Data presented last week at the American Diabetes Association meeting in New Orleans appear to put linagliptin in the same ballpark as Januvia and other late-stage dipeptidyl peptidase-4 inhibitors in terms of HbA1c reduction. Linagliptin plus metformin met the primary endpoint of reduction in HbA1c from baseline vs. metformin plus placebo at 12 weeks in an international Phase II trial in 268 patients who were inadequately controlled on metformin.

Placebo-adjusted reductions were -0.4% for 1 mg linagliptin, -0.73% for 5 mg and -0.67% for 10 mg (p<0.05 for all), similar to reductions seen in 24- and 26-week trials of other DPP-4 inhibitors in the same population (see "DPP-4 Face-Off").

According to Corporate VP of Medical Affairs Klaus Dugi, Boehringer Ingelheim expects to see similar HbA1c reductions in its 24-week Phase III trials.

"For this trial, we saw that there was quite a...

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