The study programme follows pre-clinical research results and comprises at least three small scale clinical trials evaluating various metabolic parameters.
The first Phase IIa study to commence is a multi-centre, randomised, double blind, placebo controlled, parallel group pilot study in the treatment of dyslipidaemia in patients with type 2 diabetes.
At least two additional studies are planned as part of this programme, out of which one is due to start later this year and another is due to start in 2011.
GW Pharma said that the overall programme is aimed at examining the effects of its Cannabinoids on a range of features of the metabolic syndrome including cholesterol, lipid parameters, glucose control and insulin sensitivity.
GW Pharma claimed that this progress into Phase IIa clinical trials follows a pre-clinical research programme on ita cannabinoids in several models of type 2 diabetes at the GW Metabolic Research Laboratory.
Reportedly, this research has shown desirable effects of a number of GW cannabinoids on plasma insulin, leptin and adiponectin levels, hormones of particular relevance to the development and treatment of diabetes and metabolic function.
Additionally, these results have shown a reduction in total cholesterol with an increase in the proportion of HDL (good) cholesterol.
GW Pharma R&D director Stephen Wright said that the Phase II study is the first of a series of pilot Phase II studies that the company aims to perform over the next 12-18 months to evaluate its new Cannabinoid product candidates in the field of diabetes and metabolic syndrome.