Assessment of Insulin Action Under Varying Glycemic Conditions

• Research type

  Research Study

• Full title

  Assessment of Insulin Action Under Varying Glycemic Conditions

• IRAS ID

  122307

• Contact name

  Pui M Leung

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2012-005473-31

• ISRCTN Number

  To be applied for

• Research summary

  The purpose of this study is to investigate the effect of Insulin on the body and the length of time the body takes to break down this insulin over varying levels of blood sugar values within the body. The study will involve an experimental technique called the glucose clamp procedure. This procedure has been developed so that we can learn more about drugs (such as insulin) that will help to treat people with diabetes.During the procedure an infusion of glucose is administered in order to maintain a stable blood glucose level. A euglycaemic clamp is a method by which the length of action of insulin can be measured. The amount of glucose used by the body during the clamp procedure reflects the activity of the insulin being tested. The Effectiveness of the insulin is determined by the variability in glucose blood sugar readin's. This method is employed as a safe way to administer an insulin product, as it reduces the risk that the subject may become unwell due to reduced blood sugar. It is essential for the validity of these studies to demonstrate that this method can be used in a reproducible way. This is a single site, double-blind, 9-period assessment of 12 healthy male volunteers.

• REC name

  Wales REC 1

• REC reference

  13/WA/0007

• Date of REC Opinion

  7 Feb 2013

• REC opinion

  Further Information Favourable Opinion