QCL-105458 (PDY11431)

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, two-sequence, two-treatment cross-over study assessing the effect of a single subcutaneous injection of 20 µg lixisenatide (AVE0010) on gallbladder motility in healthy male and female subjects. (QCL-105458)

• IRAS ID

  53679

• Contact name

  Joanne Collier

• Sponsor organisation

  Sanofi Aventis Deutschland GmbH

• Eudract number

  2010-019229-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of the study is to compare how the drug lixisenatide affects the emptying of the gallbladder. Lixisenatide is a glucagon-like peptide-1 (GLP-1) agonist, which means that it has a similar structure and comparable effect to the endogenous substance, glucagon-like peptide-1 (GLP1). GLP-1 is a hormone formed in the intestine wall and released into the bloodstream when food is consumed. It is characterised in particular through the following effects: • It stimulates the release of insulin from the pancreas. • It delays the emptying of the stomach and also leads, in this context, to a reduction in appetite and feeling of thirst. • It lowers the blood concentration of glucagon, a blood sugar increasing hormone. In the blood, GLP-1 is broken down within a few minutes and must therefore be constantly produced, making it unsuitable as a medicine. In contrast to this, lixisenatide has a significantly more prolonged effect. Like insulin, lixisenatide is injected under the skin and should predominantly lead to better blood sugar levels after meals. According to previous findings, lixisenatide works optimally at a dose of 20 µg once daily. There are similar medicines to the study drug already prescribed to diabetic patients at the moment (Byetta© (exenatide), Victoza© (liraglutide)), or undergoing clinical testing. A few patients (less than 2 cases per 1000 years of exposure) who were administered these similar medicines became ill with an acute inflammation of the pancreas (pancreatitis). However, it is currently not known whether usage of the study drug may increase the risk of pancreatitis. Pancreatitis causes symptoms such as pain in the upper area of the belly (abdomen) and vomiting. One theory is that these drugs may increase the risk of developing pancreatitis by affecting how well the gallbladder empties. This study is being conducted to see if Lixisenatide affects gallbladder emptying.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/7

• Date of REC Opinion

  10 Jun 2010

• REC opinion

  Further Information Favourable Opinion