Effect of Oral Insulin

• Research type

  Research Study

• Full title

  A Phase 2 Study to Evaluate the Effect of Oral Insulin (Capsulin) on Glucose and Lipid Metabolism in Type 2 Diabetes.

• IRAS ID

  92496

• Contact name

  Bain Stephen

• Sponsor organisation

  Abertawe Bro Morgannwg University Health Board

• Eudract number

  2011-004390-85

• ISRCTN Number

  1

• Research summary

  The study will be a phase 2, single centre, single-blind, placebo-controlled, escalating dose study evaluating the effect of oral insulin (Capsulin) on blood glucose levels in patients with type 2 diabetes. The study will involve 8 patients with type 2 diabetes and will involve 4 visits to a clinical trials unit each for a period of approximately 13 hours. The maximum study duration for each subject will be approximately 6 weeks from the first to the last visit. Subjects to attend assessment days in fasted state (10 hours) Subjects will take placebo medication twice a day for 6 days and the endpoints of the study measured after a 12 hour observation period in a clinical trial unit involving 3 standard meals with the remainder of the monitoring being conducted at home using self monitoring of blood glucose. The same process will be repeated with the subjects taking 75U, 150U or 300U of oral insulin twice a day for 7 days in an ascending order.

• REC name

  Wales REC 1

• REC reference

  12/WA/0181

• Date of REC Opinion

  13 Aug 2012

• REC opinion

  Further Information Favourable Opinion