A study comparing the following investigational medicinal products in the treatment of high blood cholesterol and triglicerides in subjects with type 2 diabetes: i) GW42003: GW42004 (1:1 ratio); ii) GW42003: GW42004 (20:1 ratio); iii) GW42003; and iv) GW42004
- Conditions
- Dyslipidaemia in subjects with type 2 diabetes who have failed to achieve satisfactory lipid control with existing therapies.MedDRA version: 14.1Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2010-020458-33-GB
- Lead Sponsor
- GW Pharma Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
For inclusion in the study subjects must fulfil ALL of the following criteria:
- Subject is aged 18 years or above;
- Clinically diagnosed with Type 2 diabetes, with residual islet cell function;
- Diet controlled Type 2 diabetes or receiving oral metformin (or other biguanides) and/or sulphonylurea as anti-diabetic treatment who have received a stable dose for at least three months prior to enrolment (Visit 1);
- HDL cholesterol = 1.3 mmol/L (females), = 1.2 mmol/L (males);
- Haemoglobin A1c level of = 10%;
- Triglycerides = 10 mmol/L;
- Willing to maintain a stable dose of oral anti-diabetic and lipid-lowering agents/medications that may have an effect on plasma/serum glucose, insulin or lipid parameters for the duration of the study, if appropriate;
- No changes in diet or exercise for four weeks prior to and for the duration of the study (in the opinion of the investigator);
- Capable of complying with the study requirements and completing the study (in the opinion of the investigator);
- Willing and able to give informed consent for participation in the study;
- Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable;
- Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
The subject may not enter the study if ANY of the following apply:
- Subject is taking insulin (i.e. they are insulin-dependent);
- Taking the following categories of medicines: fibrates, TZDs, 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 (excluding episodes of reactive depression at the discretion of the investigator);
- BDI Score = 15;
- 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 prior to 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. occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for 3 months thereafter (however a male condom should not be used in conjunction with the female condom);
- 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 (Visit 1) and for the duration of the study
- Received an unapproved 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;
- Previously randomised into this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method