PK/PD study in paediatric and adult patients with type 2 diabetes

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo controlled trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of lixisenatide in paediatric (10 - 17 years old) and adult patients with type 2 diabetes

• IRAS ID

  101773

• Contact name

  Ashley Brooks

• Sponsor organisation

  Sanofi-Aventis Deutschland GmbH

• Eudract number

  2011-004584-67

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The study drug is being developed as a potential treatment for type 2 diabetes mellitus (T2DM). T2DM is estimated to affect 285 million people worldwide. The disease usually develops over time, particularly in obese patients, and is diagnosed by high blood glucose levels (a type of sugar) which can lead to serious health complications including increased risk of heart disease, stroke, problems with circulation (occasionally leading to limb amputation), blindness, and kidney failure. Until recently, T2DM has been exclusively an adult disease however an increasing prevalence of obesity in children has led to an increasing number of children are now being diagnosed with the disease. Glucagon-like peptide-1 (GLP-1) is a protein normally secreted in the body after a meal to help the body control the level of sugar in the blood. GLP-1 only works for a few minutes after each meal, which is usually sufficient in healthy people. The study drug works in a similar way to GLP-1 but acts for a longer period to help control blood sugar levels in T2DM patients who are unable to control their own blood sugar levels naturally. This is a multi-site study involving T2DM patients, with up to 12 adult patients to be included in the study at this site, and up to 12 paediatric (children) patients to be included in other sites. There are 3 treatment periods in this study. In each treatment period, the patients will receive a subcutaneous (beneath the skin) injection of different doses of the Study Drug or placebo. The study is expected to last approximately 7 weeks from screening till the last study visit. The main purpose of the study is to prove that Study Drug is effective in reducing blood glucose levels after a meal in the paediatric population as compared to the adult population.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0135

• Date of REC Opinion

  19 Mar 2012

• REC opinion

  Favourable Opinion