GWMD1092 - GW42003:GW42004 together plus alone in type II diabetes

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo controlled, parallel group, pilot study of 1:1 and 20:1 ratio of formulated GW42003 : GW42004 plus GW42003 and GW42004 alone in the treatment of dyslipidaemia in subjects with Type 2 diabetes

• IRAS ID

  54882

• Contact name

  Garry Tan

• Sponsor organisation

  GW Pharmaceuticals Limited

• Eudract number

  2010-020458-33

• ISRCTN Number

  N/A

• Research summary

  This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two cannabinoids GW42004 (delta-9-tetrahydrocannabivarin (THCV)) and GW42003 (cannabidiol (CBD)) alone, or in combination (at two different ratios combined (20:1 CBD : THCV and 1:1 THCV : CBD)) in patients with Type 2 diabetes. This is the first study to determine whether the study medications have a positive benefit for subjects on their cholesterol levels, body weight, liver fat content and other metabolic parameters compared with a placebo medication. This is important research since it will address whether subjects who are already taking oral anti-diabetic medication with / without cholesterol-lowering medications (such as ??statins?) who are not adequately controlled with their existing medications, gain additional benefit from taking these new medications. The main benefit to subjects in the study are likely to be in the areas of reducing total cholesterol (and increasing the ??good? cholesterol (HDL cholesterol) and decreasing the amount of ??bad? cholesterol (LDL cholesterol)). In addition, the amount of fat present in subject??s liver may be reduced, and they may lose some body fat. This study involves a total of 50 participants. This is a randomised, double-blind, placebo-controlled parallel-group pilot study lasting 16-19 weeks. There is a total of 6 visits. Subjects with Type 2 diabetes and high cholesterol will be approached/considered for screening. If eligible, each subject enrolled will be assessed for a baseline period between 14-35 days. If they are still eligible after this time, subjects will be randomly allocated to treatment with a study medication or placebo for a total of 13 weeks. Patients will complete a daily diary supplying information on their diabetic & dyslipidaemic medication usage; food frequency & physical activity questionnaires. Other assessments include monitoring of adverse events, vital signs, blood/urine samples.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/42

• Date of REC Opinion

  6 Jul 2010

• REC opinion

  Further Information Favourable Opinion