Research Update: Novo Nordisk discontinues phase 3 clinical trial with NovoSeven(R) in trauma
Novo Nordisk today announced thedecision to discontinue the phase 3clinical trial with NovoSeven® for the treatment of bleeding inpatients with severe trauma. The decision was made based on theresults of an analysis for futility conducted by the independentDataMonitoring Committee. The phase 3 trial was evaluating theefficacyand safety of NovoSeven® in severely injured trauma patients withbleeding refractory to standard treatment. The primary efficacyendpoint of the study was mortality and morbidity.
Due to an observed lower mortality than anticipated in the overallstudy group (around 10% in the phase 3 trial in total compared tomore than 25% in the phase 2 trial), a futility analysis wasconducted to assess the likelihood of reaching a successfuloutcomeon the primary endpoint. The analysis predicted a low likelihoodofobtaining a positive trial outcome with the planned studypopulation,and as a consequence, Novo Nordisk has decided to discontinue thetrial.
The decision is not due to safety concerns. In its latest reviewonsafety data of 31 March 2008, the independent Data MonitoringCommittee recommended continuation of the study.
Mads Krogsgaard Thomsen, executive vice president and chiefscienceofficer said: "It is regrettable that this trial is coming to anend.It has, however, already now provided a lot of important data onthetreatment of severely injured patients. We will share thesefindingswith the medical community as soon as the full clinical analysishasbeen completed."
The decision to discontinue the phase 3 clinical study withNovoSeven® for the treatment of bleeding in patients with severetrauma does not impact Novo Nordisk's expectations for thecompany'sfinancial results for 2008, which were provided on 30 April inconnection with the release of the financial results for the firstquarter of 2008.
About the study
The study had enrolled more than 550 patients of the planned 1,502in24 countries. It was a multicentre, randomised, double-blind,parallel group, placebo-controlled trial to evaluate the efficacyandsafety of NovoSeven® in severely injured trauma patients withbleeding refractory to standard treatment. Randomised patientsreceived three single doses of NovoSeven® (200 mcg/kg + 100 mcg/kg+100 mcg/kg) or placebo after the transfusion of the fourth unit ofred blood cells)
The study has the primary endpoint of all cause 30-day mortalitydesigned to show superiority of NovoSeven® compared to placebo inblunt trauma patients. If not superior, the endpoint included ananalysis to demonstrate non-inferiority of NovoSeven® compared toplacebo on all cause 30-day mortality and superiority ofNovoSeven®compared to placebo on pulmonary and/or renal dysfunctionrequiringongoing medical intervention at day 30 in blunt trauma patients.(ClinicalTrials.gov. Identifier: NCT00184548).
Novo Nordisk is a healthcare company and a world leader indiabetescare. In addition, Novo Nordisk has a leading position withinareassuch as haemostasis management, growth hormone therapy and hormonereplacement therapy. Novo Nordisk manufactures and marketspharmaceutical products and services that make a significantdifference to patients, the medical profession and society. Withheadquarters in Denmark, Novo Nordisk employs approximately 26,300employees in 80 countries, and markets its products in 179countries.Novo Nordisk's B shares are listed on the stock exchanges inCopenhagen and London. Its ADRs are listed on the New York StockExchange under the symbol 'NVO'. For more information, visitnovonordisk.com.