TESINT

• Research type

  Research Study

• Full title

  Trial evaluating the effect of sitatliptin in type 1 diabetes

• IRAS ID

  77406

• Contact name

  Dr Stephen Gough

• Sponsor organisation

  Clinical Trials and Research Governance, University of Oxford

• Eudract number

  2011-002607-15

• ISRCTN Number

  na

• Research summary

  In people with type 2 diabetes who take insulin, sitagliptin, a blood glucose lowering tablet, improves glucose levels and reduces hypoglycaemia. Our study will look at whether sitagliptin could also potentially be of benefit to people with type 1 diabetes and, if so, which people might benefit the most from adding sitagliptin to their insulin therapy. Two groups each of 15 people with type 1 diabetes will be studied. Group 'A', who still have some ability to make insulin and Group 'B' who do not. People in Group A and B will be randomly chosen by a computer (like the flip of a coin) to get either an active sitagliptin or placebo tablet (dummy pill) for 4 weeks. After a further 4 weeks off the first tablet ("wash-out period") the groups will switch to the opposite treatment for a further 4 weeks, such that by the end of the study each participant will have been allocated both sitagliptin and placebo. At the beginning and end of each treatment period we will perform 72 hour continuous glucose monitoring (which accurately measures blood sugars every 5 minutes) to see if there is a difference between sitagliptin and placebo, and also between Groups A and B. To better understand how sitagliptin might be making a difference, we will also measure two important hormones that control blood sugar, insulin and glucagon after a test meal and during a 'clamp' procedure. We will also examine the rise in glucose after each meal, overall blood glucose control (HbA1c), insulin dose and rates of hypoglycaemia (low blood sugar). If our study shows a benefit with sitagliptin, it is possible that this once daily tablet could be used in addition to insulin to further improve blood sugar levels and reduce episodes of hypoglycaemia in people with type 1 diabetes.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0270

• Date of REC Opinion

  22 Nov 2011

• REC opinion

  Further Information Favourable Opinion