Addition of novel agent to metformin to treat overweight type 2 diabetes did not meet efficacy endpoint


News - June 30, 2015

Results of treatment of overweight type 2 diabetic patients with the potential first-in-class 11β-hydroxysteroid dehydrogenase type 1 (11β HSD1) inhibitor BI187004/VTP-34072, in addition to metformin in an ongoing phase 2 proof-of-concept clinical trial, have been presented.
BI187004/VTP-34072 is an 11β HSD1 inhibitor that is being studied for the treatment of type 2 diabetes and metabolic syndrome. In preclinical studies, BI187004/VTP-34072 had a positive impact on multiple cardiovascular and metabolic risk factors associated with metabolic syndrome, which differentiates it from other classes of type 2 diabetes drugs. BI187004/VTP-34072 is currently being studied in an ongoing Phase 2 proof-of-concept trial assessing efficacy and tolerability in diabetic patients on stable doses of metformin and as monotherapy.

Safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of BI187004/VTP-34072 as monotherapy or as an add-on to metformin background therapy are being investigated over 28 days in a randomised, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus. Primary efficacy data (fasting plasma glucose) from the metformin arm did not meet predefined endpoint criteria. Data from the placebo-controlled monotherapy arm of the trial, which is still ongoing, are expected to be reported later this year.
 Press release Vitae Pharmaceuticals, June 29, 2015

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