Safety, blood levels and effects of repeated doses of SAR351034; v 1

• Research type

  Research Study

• Full title

  Randomized, double-blind, placebo-controlled dose-escalation study to investigate the safety and tolerability and the pharmacokinetics of 15-days repeated oral doses of SAR351034 in healthy elderly male and female subjects (HMR code 08-017)

• IRAS ID

  18821

• Contact name

  Steve Warrington

• Sponsor organisation

  sanofi−aventis recherche & développement

• Eudract number

  2008-005981-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  SAR351034 is a new experimental treatment for type 2 diabetes. People with diabetes can??t process the sugary and starchy foods in their diet quickly enough, and so have high blood sugar. We hope that SAR351034 will reduce blood sugar by increasing the body's response to a hormone called insulin, which controls the level of sugar in our blood. We also hope that SAR351034 will decrease the Ó?bad? fats in the blood, and increase the Ó?good? fats. that's important, because diabetics are prone to illnesses associated with high levels of 'bad' fats, such as heart attacks.In this study, We'll test SAR351034 in people aged over 65 years, because most people with type 2 diabetes are middle-aged or elderly. We'll test repeated doses of SAR351034, to find out its side effects, blood levels and effects on substances in the blood linked to type 2 diabetes, such as fatty substances, sugar, and the hormone insulin. We'll also study how genes (pieces of DNA) affect how the body responds to or handles SAR351034. We'll give up to 60 healthy men and women 15 daily doses. We'll decide the doses as the study progresses, but the highest daily dose will be 200 mg SAR351034. Some participants will take dummy medicine instead of SAR351034 ?? neither they nor we will know which they??re taking.Participants will take up to 7 weeks to finish the study. They'll make 1 outpatient visit, and stay on the ward for 26 nights.Healthy volunteers can??t benefit from SAR351034, but they might benefit from our screening tests, if we found an important problem.A pharmaceutical company (sanofi-aventis) is funding the study.The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising; by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0709/21

• Date of REC Opinion

  1 May 2009

• REC opinion

  Further Information Favourable Opinion