DPP4 inhibitors in Type 1 Diabetes Mellitus

• Research type

  Research Study

• Full title

  DPP4 inhibitors in Type 1 Diabetes

• IRAS ID

  106795

• Contact name

  Rory McCrimmon

• Sponsor organisation

  University of Dundee

• Eudract number

  2012-002407-18

• Research summary

  DPP4 inhibitors (DPP4i) are drugs that have had a license for use in those with Type 2 Diabetes since 2007. It has been shown to reduce glucosflutuations particularly after meals. We know that glucosflutuations can be a significant risk factor for hypoglycaemia(low blood sugars) and vascular dysfunction (health of the blood vessel). We know patients who have had diabetes for a number of years through experiencing recurrent hypoglycaemia, have reduced adrenaline responses to hypoglycaemia, and therefore have reduced awareness of hypoglycaemia. This is dangerous as it increases frequency of a severe hypoglycaemic attack, whereby the patient needs third party assistance for recovery. On average patients with Type 1 diabetes have at least one episode of severe hypoglycaemia/year, which increases to an average of 3-4 after 15 years of diagnosis. Consequently our aim is to see whether DPP4i by reducing glucosflutuations and freqency of hypoglycaemia, would improve adrenaline responses to an insulin induced hypoglycaemia, which would correlate with improved awareness of hypoglycaemia. The study will be a cross-over randomised clinical trial, and therefore each patient will have 3 months of DPP4i treatment and 3 months of placebo treatment separated by a washout period. Following each treatment arm, we will assess the adrenaline response to hypoglycaemia, by performing a clamp technique, whereby we slowly bring the blood sugars down in a very controlled fashion, and assess symptomatic (symptom responses), hormonal (adrenalin, noradrenalin, and glucagon) and cognitive responses to hypoglycaemia. Following each treatment arm, we will also assess various other parameters, including non-invasive testing for blood vessel health.

• REC name

  Scotland A REC

• REC reference

  12/SS/0125

• Date of REC Opinion

  14 Aug 2012

• REC opinion

  Favourable Opinion