Corporate Magazine 2012 - Boehringer Ingelheim

esearch & developmentperspectives for medical innovationLINAGLIPTIN DEVELOPMENT PROGRAMMEEMPAGLIFLOZIN DEVELOPMENT PROGRAMMEphase ιιι25 studiesapprox. 5,000 patientsphase ιιι11 studiesapprox. 7,800 patientsphase ιι5 studies,approx. 1,200 patientsphase ι51 studiesapprox. 1,500 patientscardiovascular outcome studycarolina®6,000 patients for approx. 6 yearsphase ιι8 studies,approx. 2,000 patientsphase ι26 studiesapprox. 800 patientscardiovascularoutcome studyempa-clarityapprox. 7,000 patientsfor approx. 5 years2004 2006 2008 2010 2012 2014 2016 2018 2004 2006 2008 2010 2012 2014 2016 2018In contrast to all other drugs, these donot slow glucose uptake from the gutor change its disposition within thebody, but promote its excretion via thekidneys, turning the former diagnosticmeasure of sugar in the urine into atherapeutic approach.change in HbA1c from baseline comparedto placebo, was met. Filing forregulatory review in the USA, Europeand Japan is expected in 2013.Weight loss and bloodpressure loweringPooled data from the phase II studieshave demonstrated that empagliflozintreatment not only avoids weight gain,but actually causes some weight lossand additionally some blood pressurelowering, addressing multiple importantcontributors to overall health.SGLT2-INHIBITORS - MECHANISM OF ACTIONEmpagliflozin in phase III studiesIts efficacy and safety is determinedin 12 multinational phase III studieswith over 14,500 patients, includinga cardiovascular outcome study thatis one of the largest of its kind.In the four completed phase III clinicaltrials for empagliflozin, the primaryefficacy endpoint, defined as significantglucosesglt2-inhibitorproximaltubuleglucoseurinary glucose excretion,loss of caloriesSGLT2-inhibitors do not slowglucose uptake from the gut orchange its disposition within thebody, but promote its excretionvia the kidneys, turning theformer diagnostic measure ofsugar in the urine into a therapeuticapproach.Industry-leading development of oral antidiabetes drugs57