Study to assess the PK and PD of a Basal Insulin V1

• Research type

  Research Study

• Full title

  A Two-Part Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin

• IRAS ID

  55624

• Contact name

  Peter Dewland

• Sponsor organisation

  Merck Sharpe and Dohme Corp.

• Eudract number

  2010-019674-33

• ISRCTN Number

  Not Submitted

• Research summary

  The aim of this study is to assess the variability in various parameters associated with an isoglycaemic clamp procedure in healthy volunteers and patients with Type 1 Diabetes Mellitus. An isoglycaemic clamp is a method by which the length and strength of action of insulin can be measured. At the same time an infusion of glucose is also administered and the amount of glucose used by the body reflects the activity of the insulin. The rate at which glucose given is varied to maintain a set level of sugar in the blood that can be analysed and the Effectiveness of the insulin determined.This study has two parts - part I in diabetic patients and part II in healthy volunteers. Both parts of the study have the same overall study design and the 2 parts may occurisimultaneously or in any sequence. Two sites will participate in this study: ICOn'san Antonio in the USA (Part I) and ICON Manchester, UK (parts I and II). Each part may be conducted at one or both centres. The patients involved in this study will not receive any benefit from taking part. This will be an open label study using a marketed form of insulin. Each participant will take part in a screening visit, two study periods and a follow up visit. At the study visits each participant will undergo an isoglycaemic clamp procedure which will last for 30 hours. This procedure requiresa high degree of accuracy in order to be able to assess the action of the insulin when using a new product. This study will therefore look at the accuracy obtained using a marketed product to show that this tool will be efficient, accurate and reproducible when looking at a new compound.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/61

• Date of REC Opinion

  3 Aug 2010

• REC opinion

  Favourable Opinion