Conditions: Dyslipidemias Diabetes Mellitus, Type 2
Keywords: Dyslipidemias Diabetes Liver Fat Body Fat
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 62
Healthy volunteers: no

Brief summary:
This 15-19 week study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two cannabinoids: GWP42004 and GWP42003 alone, or in combination 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.

Detailed description:
In this study there was a 1-5 week baseline period followed by a 13 week treatment period, and a one week follow-up. Eligible subjects entered the study at a screening visit (Visit 1) before returning for randomisation (Visit 2, Day 1). At the discretion of the investigator (based on individual subjects), Visit 1 could be split into two separate visits (Visits 1A and B) to allow a 21-day washout period of prohibited medications prior to blood sampling for eligibility. Further outpatient study visits (for assessment purposes) took place at the study site at the end of Week 4 of treatment (Visit 3, Day 29), and at the overall end of treatment at Week 13 (Visit 5, Day 92). A telephone assessment was also performed at Day 57 (Visit 4) and at Week 14 (Visit 6, Day 99) for safety follow-up purposes.

During the 13 week randomised treatment phase, subjects received blinded, oral doses of their allocated randomised treatment twice daily. Treatment was self-administered on an outpatient basis, once in the morning and once in the evening for 13 weeks. Subjects were instructed to time study medication to 30 minutes before breakfast and evening meals.

Physical and metabolic parameters were assessed before, during and after treatment to evaluate clinical response. Diabetic and dyslipidaemic medication usage (where applicable), and appetite 0-10 NRS data were collected daily during the treatment period, using the study diary.

Arms:
arm 1: Contains GWP42004 5 mg and placebo (excipients only) arm 2: Contains 5 mg each of GWP42003 and GWP42004 arm 3: Contains 100 mg GWP42003 and 5 mg GWP42004 arm 4: Contains excipients only arm 5: Contains 100 mg GWP42003 and placebo (excipients only)

Interventions: intervention 1: GWP42003 intervention 2: GWP42003 intervention 3: GWP42004 intervention 4: Placebo
Intervention descriptions: intervention 1: 100 mg capsules, PO, BD, 91 days intervention 2: 5 mg capsules, PO, BD, 91 days intervention 3: 5 mg capsules, PO, BD, 91 days intervention 4: 0 mg capsules, QDS, PO, 91 days

Protocol document: