Investigation of GMC-252 in healthy subjects + subjects with T2DM - v1

• Research type

  Research Study

• Full title

  A Double-Blind, Placebo-Controlled, Randomised, Two Part Study of the Safety and Pharmacokinetics of GMC-252 in A) Healthy Male Subjects, including a Comparison of GMC 252 Dosing in the Fed and Fasted States, and B) in Subjects with Type 2 Diabetes Mellitus.

• IRAS ID

  112015

• Contact name

  SALVATORE FEBBRARO

• Sponsor organisation

  GMC-252 S.L. (A wholly owned subsidiary of Genmedica Therapeutics S.L)

• Eudract number

  2012-003185-41

• ISRCTN Number

  1

• Research summary

  The purpose of this study is to investigate a drug called GMC-252 and to assess the the safety of this drug when different amounts are given. The study will also look at how quickly GMC-252 enters the bloodstream, is distributed in the blood, broken down and disposed of by the body after it is taken as a single dose. GMC-252 is being developed for the treatment of diabetes mellitus, specifically Type 2 diabetes (the most common form). The study is to find out how much of GMC-252 (the dose) should be given to patients with Type 2 diabetes mellitus. This study consists of 2 parts (Parts A and B). Part A is performed in healthy male volunteers. Part B is performed in patients with Type 2 diabetes mellitus. Part A will include 18 healthy male participants, split in to 2 groups of 9 (Group 1 and Group 2). Participation in the trial will last for approximately 8-10 weeks (depending on whether you need to return for the additional treatment period), which includes a 21 day ??screening?? period, the treatment visits and a final Follow-up visit. In Part B, 9 subjects will receive a single dose of GMC-252 or placebo (A placebo is a ??dummy treatment? which looks just like the study medicine but contains no active drug) on the morning of Day 1. Subjects will then remain at Simbec until 72 hours post dose. Participation in Part B of the trial will last for approximately 5 weeks, which includes a 21 day ??screening?? period, 1 treatment visit and a Final Follow-up visit.

• REC name

  Wales REC 2

• REC reference

  12/WA/0223

• Date of REC Opinion

  8 Aug 2012

• REC opinion

  Further Information Favourable Opinion