Systems Biology Protocol - Vildagliptin

• Research type

  Research Study

• Full title

  Systems biology investigation of the effect of DPP-4 inhibitors on glucose metabolism and beta cell function in non-diabetic and type 2 diabetic individuals

• IRAS ID

  12605

• Sponsor organisation

  Oxford University

• Eudract number

  2008-007655-27

• ISRCTN Number

  n/a

• Research summary

  Type 2 diabetes is characterised by a combination of insulin deficiency and resistance to its action. Insulin is secreted from the pancreas from beta cells. After a meal, insulin secretion is increased by a hormone called GLP-1 (Glucagon-like peptide 1) secreted from the gut. In type 2 diabetes the level of GLP-1 is low and available GLP-1 is quickly degraded. Vildagliptin is a new diabetes drug that stops GLP-1 degradation. This means GLP-1 can act for longer and this increases the amount of insulin available in the body after a meal. OBJECTIVEWe propose to study how vildagliptin increases the insulin secreting capacity of beta cells. We give an infusion of glucose and insulin and put the beta cell under stress. This is called a "clamp technique". It will allow a comparison between insulin and glucose levels in healthy people and diabetes. The data we obtain are plotted as graphs. These are called "insulin/glucose dose response curves." STUDY DESIGNThis is a double blind cross-over study. Subjects receive 3 weeks each of vildagliptin and placebo. The subjects will be admitted on two separate occasions for the clamp studies following each 3 week treatment phase. We propose to recruit 13 healthy individuals and 13 individuals with type 2 diabetes who meet inclusion and exclusion criteria. All subjects will attend 4 visits: screening, randomisation and 2 clamp visits. Healthy volunteers will attend 1 extra visit for fasting blood glucose test to confirm they are not diabetic.Diabetic subjects will be selected from existing databases and through Thames Valley Diabetes Research Network and invited to participate at clinic visit or by letter. Non-diabetic subjects will be recruited from existing databases and by local advertisement. For each clamp visit, subjects will be admitted to our centre and we will undertake sampling as outlined in the study protocol.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  09/H0505/75

• Date of REC Opinion

  19 Oct 2009

• REC opinion

  Further Information Favourable Opinion