Study to Evaluate the Safety, Tolerability, PK and PD of MK-1293

• Research type

  Research Study

• Full title

  A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1293 and to Compare its Pharmacologic Properties to Those of Another Basal Insulin in Healthy Subjects

• IRAS ID

  70401

• Contact name

  Anthony Priestley

• Sponsor organisation

  Merck, Sharpe and Dohme

• Eudract number

  2010-024022-37

• Research summary

  The study has the following 3 aims:1) To test the safety and tolerability of single doses of the research study drug, MK-1293.2) To measure and compare the action of MK-1293 and Lantus© (insulin glargine) with regareas to removing glucose (sugar) from the blood after they are injected in the skin.Each drug will be tested separately.3) To measure and compare the amount of MK-1293 and Lantus© (insulin glargine) in your blood after after they are injected in the skin.Each drug will be tested separately.MK-1293 and Lantus© (insulin glargine) are both insulin preparations that will be used in this study. MK-1293 is a new drug that has not yet been approved formsale. Lantus© has been available on the market for a number of years.This is a single centre, doubleblind, randomised 2-way Crossoverestudy. Each subject will participate in a screening visit, two study visits and 3 follow up visits.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/29

• Date of REC Opinion

  24 Jan 2011

• REC opinion

  Further Information Favourable Opinion