Study in patients who experienced an allergic reaction to Taspoglutide

• Research type

  Research Study

• Full title

  AN INTERVENTIONAL NON-THERAPEUTIC STUDY TO ASSESS EX VIVO BASOPHIL ACTIVATION IN RESPONSE TO VARIOUS PREPARATIONS OF TASPOGLUTIDE AND RELATED ITEMS IN BLOOD SAMPLES FROM SUBJECTS WHO PREVIOUSLY RECEIVED TASPOGLUTIDE AND EXPERIENCED A SYSTEMIC ALLERGIC REACTION

• IRAS ID

  85322

• Sponsor organisation

  Ipsen Pharma SAS

• Eudract number

  2011-001935-21

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Type 2 diabetes is a metabolic disorder characterised by elevated blood glucose levels. It is often accompanied by other complications such as high blood pressure and blocking of the arteries and as such causes a significant number of fatalities. The incidence of this disease is increasing worldwide and there is a need for new treatments that are more effective and better tolerated than those currently available.Taspoglutide is a new antidiabetic treatment with a novel mechanism of action. It is in the late stages of clinical development, having just finished a large phase III programme. Taspoglutide was shown to be effective during these trials, however there were a number of serious and non-serious allergic reactions experience by the subjects involved. At present it is not clear whether these reactions were in response to the Taspoglutide itself or to inpurities contained within the Taspoglutide product. This study aims to clarify this uncertainty by collecting a blood sample from subjects who experienced an allergic reaction during the phase III trials and exposing the blood to taspoglutide with different levels of purity, placebo (dummy drug), and liraglutide which is a similar compound to taspoglutide. A basophil activation test will be performed to see which products trigger the release of IgE and hence cause an allergic reaction. This study will involve about 29 subjects from across the world. It will involve collecting subject consent and the collection of a single blood sample. The study is non-therapeutic so no study drug will be given to the subjects.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/1308

• Date of REC Opinion

  24 Aug 2011

• REC opinion

  Favourable Opinion