GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes
Condition: Dyslipidemias; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
Intervention: GWP42003; GWP42003; GWP42004; Placebo
Intervention description: 100 mg capsules, PO, BD, 91 days; 5 mg capsules, PO, BD, 91 days; 5 mg capsules, PO, BD, 91 days; 0 mg capsules, QDS, PO, 91 days
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dyslipidemias; Diabetes; Liver Fat; Body Fat

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically diagnosed with Type 2 diabetes, with residual islet cell function;

          -  Diet controlled or receiving oral anti-diabetic treatment (metformin or other
             biguanides and/or sulphonyl ureas) who have received a stable dose for at least 3
             months prior to enrollment;

          -  High Density Lipoprotein cholesterol ≤ 1.3mmol/L (females), ≤ 1.2mmol/L (males);

          -  Glycosylated haemoglobin levels of ≤ 10%;

          -  Triglycerides ≤ 10mmol/L;

          -  Willing to maintain a stable dose of oral anti-diabetic and/or lipid-lowering
             agents/medications that may have an effect on plasma/serum glucose, insulin or lipid
             parameters for the duration of the study, where applicable;

          -  No changes in diet or exercise for four weeks prior to and subject agrees to keep
             stable for the duration of the study (in the opinion of the investigator);

        Exclusion Criteria:

          -  Subject is taking insulin (i.e. they are insulin-dependent);

          -  Taking the following categories of medicines: fibrates, Thiazolidinediones,
             therapeutic Omega-3 fatty acids, alpha-glucosidase inhibitors and unwilling abstain
             for the duration of the study;

          -  Currently using or has used recreational cannabis, medicinal cannabis, cannabinoid
             medications (including Sativex®), or synthetic cannabinoid based medications within 30
             days prior to study entry and unwilling to abstain for the duration for the study;

          -  Any known or suspected history of:

               -  alcohol or substance abuse

               -  epilepsy or recurrent seizures;

          -  Any known or suspected history of depression sufficient to require treatment with
             antidepressants or disrupt ordinary life at the discretion of the investigator);

          -  Subject who has significant history of anxiety, suicidal ideation or self-harm;

          -  Clinically significant cardiac, renal or hepatic impairment in the opinion of the
             investigator;

          -  Genetic dyslipidaemic condition in the opinion of the investigator;

          -  Currently taking a lipid lowering agent and a stable dose has not been maintained for
             at least four weeks randomisation (Visit 2);

          -  Female subject, who is pregnant, lactating or planning pregnancy during the course of
             the study and for three months from date of last dose;

          -  Female subjects of child bearing potential unless willing to use two forms of
             contraception, one of which must be barrier contraception (e.g. female condom or
             occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and
             for three months thereafter;

          -  Male subjects whose partner is of child bearing potential, unless willing to use an
             appropriate barrier method of contraception (condom and spermicide) in addition to
             having their female partner use another form of barrier contraception (e.g. female
             condom or occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the
             study and for three months thereafter;

          -  Body weight > 150kg;

          -  Travel outside the country of residence planned during the study;

          -  Currently receiving a prohibited medication and unwilling to stop at the screening
             visit and for the duration of the study;

          -  Received an unapproved Investigational Medicinal Product (IMP) within the 30 days
             before the screening visit;

          -  In the opinion of the investigator, is not considered to be suitable for the study;

          -  Any known or suspected hypersensitivity to cannabinoids or any of the excipients of
             the IMP(s);

          -  Any other significant disease or disorder which, in the opinion of the investigator,
             may either put the subject at risk because of participation in the study, may
             influence the result of the study, or the subject's ability to participate in the
             study;

          -  Has a postural drop of ≥ 20 mmHg in systolic blood pressure at Visit 1;

          -  Any abnormalities identified during the physical exam at Visit 1 that in the opinion
             of the investigator, would prevent the subject from safe participation in the study;

          -  Unwilling to abstain from donation of blood during the study.