Study of the effect of vildagliptin on insulin sensitivity.

• Research type

  Research Study

• Full title

  A single-centre, double-blind,randomised, placebo controlled, parallel-group study to assess the effect of 24 weeks of treatment with vildagliptin on insulin sensitivity and its underlying mechanisms in patients with type 2 diabetes treated with metformin.

• IRAS ID

  54726

• Contact name

  Roy Taylor

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2006-004400-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of thisstudy is to evaluate the effect of 24 weeks of treatment with vildagliptin (100mg) compared with placebo on insulinosensitivity( this is a term used to describe people who require relatively normal or low levels of insulin to process glucose(our body's primary source of energy takes the from of glucose))in 44 patients with type-2 diabetes mellitus treated with metformin (1000mg daily).This effect will beassessed as glucose Rd (rate of glucose disposal) during a hyperinsulinemic (high insulin level) euglycaemic (normal glucose level)clamp procedure. In addition the effect of vildagliptin or placebo ontriglyceride and glycogen regulation by the liver and muscle will be determined in the same patientsusing magnetic resonance techniques (MRI scan). In particular, the study will show whether reduced triglyceride and increased glycogenestorage in muscle are part of the underlying ways in which vildagliptin in order to gain a better understanding of the drug and also of type-2 diabetes.44 patientsconsented to the study will attend for a maximum of 12 visits over a 24 week period.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  10/H0907/54

• Date of REC Opinion

  27 Oct 2010

• REC opinion

  Favourable Opinion