DyslipidemiasPhase 2NCT01217112
GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes
A Phase 2 study testing GWP42003 and GWP42004 in people with Dyslipidemias and Diabetes Mellitus, Type 2, run by Jazz Pharmaceuticals at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemias, Diabetes Mellitus, Type 2
- What is being tested?
- GWP42003 and GWP42004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Oct 2010to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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;
Show all 24Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Woolpit Health Centre
Bury Saint Edmonds, IP30 9QU
Mount Farm Surgery
Bury Saint Edmonds, IP32 7EW
University of Nottingham, Medical School at Derby, Royal Derby Hospital
Derby, DE22 3DT
James Paget University Hospital
Gorleston-on-Sea, Norfolk, NR31 6LA
MAC UK Neuroscience Ltd.
Manchester, M32 0UT
About this study
Official title: A Randomised, Double Blind, Placebo Controlled, Parallel Group, Pilot Study of 1:1 and 20:1 Ratio of Formulated GWP42003 : GWP42004 Plus GWP42003 and GWP42004 Alone in the Treatment of Dyslipidaemia in Subjects With Type 2 Diabetes
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.
Read the 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.
- Conditions
- Dyslipidemias, Diabetes Mellitus, Type 2
- Being tested
- GWP42003, GWP42004, Placebo
- Keywords
- Dyslipidemias, Diabetes, Liver Fat, Body Fat
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus, Type 2, Diabetes Mellitus, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWP42003Drug
Also called Cannabidiol, CBD
100 mg capsules, PO, BD, 91 days
GWP42003Drug
Also called Cannabidiol, CBD
5 mg capsules, PO, BD, 91 days
GWP42004Drug
Also called delta-9-tetrahydrocannabivarin, THCV
5 mg capsules, PO, BD, 91 days
PlaceboDrug
0 mg capsules, QDS, PO, 91 days
| Study group | Role | What they receive |
|---|---|---|
| GWP42004 and placebo | Active comparator | Contains GWP42004 5 mg and placebo (excipients only) Receives: Drug: GWP42004; Drug: Placebo |
| 1:1 GWP42003 : GWP42004 | Active comparator | Contains 5 mg each of GWP42003 and GWP42004 Receives: Drug: GWP42003; Drug: GWP42004 |
| 20:1 GWP42003 : GWP42004 | Active comparator | Contains 100 mg GWP42003 and 5 mg GWP42004 Receives: Drug: GWP42003; Drug: GWP42004 |
| Placebo | Placebo comparator | Contains excipients only Receives: Drug: Placebo |
| GWP42003 and placebo | Active comparator | Contains 100 mg GWP42003 and placebo (excipients only) Receives: Drug: GWP42003; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
Secondary outcomes (43)
The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment
An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment
A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])
A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)
At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment
Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment
Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment
Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment
Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment
Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment
Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment
Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment
Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment
Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment
Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment
Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment
Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment
Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment
Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment
Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Measured: Baseline (Day 1) and End of treatment (Day 92)
Adverse Events as a Measure of Patient Safety
The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented.
Measured: Day 1 - Day 92
The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment
The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates 'minimal depression'. A score between 14 and 19 indicates 'mild depression'. A score between 20 and 28 indicates 'moderate depression', and a score between 29 and 63 indicates 'severe depression'. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration.
Measured: Baseline (Day 1) and the End of Treatment (Day 92)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217112
- Sponsor's protocol ID
- GWMD1092
- Other IDs
- 2010-020458-33
- Status last verified
- Sep 2022
- First submitted
- 7 Oct 2010
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jadoon KA, Ratcliffe SH, Barrett DA, Thomas EL, Stott C, Bell JD, O'Sullivan SE, Tan GD. Efficacy and Safety of Cannabidiol and Tetrahydrocannabivarin on Glycemic and Lipid Parameters in Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Pilot Study. Diabetes Care. 2016 Oct;39(10):1777-86. doi: 10.2337/dc16-0650. Epub 2016 Aug 29.
PubMed 27573936
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled, Parallel Group, Pilot Study of 1:1 and 20:1 Ratio of Formulated GWP42003 : GWP42004 Plus GWP42003 and GWP42004 Alone in the Treatment of Dyslipidaemia in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01217112
- Acronym / sponsor ID
- GWMD1092
- Conditions
- Dyslipidemias, Diabetes Mellitus, Type 2
- Keywords
- Dyslipidemias, Diabetes, Liver Fat, Body Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Posted 20 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GWP42004 and placebo | Active comparator | Drug: GWP42004, Drug: PlaceboContains GWP42004 5 mg and placebo (excipients only) |
| 1:1 GWP42003 : GWP42004 | Active comparator | Drug: GWP42003, Drug: GWP42004Contains 5 mg each of GWP42003 and GWP42004 |
| 20:1 GWP42003 : GWP42004 | Active comparator | Drug: GWP42003, Drug: GWP42004Contains 100 mg GWP42003 and 5 mg GWP42004 |
| Placebo | Placebo comparator | Drug: PlaceboContains excipients only |
| GWP42003 and placebo | Active comparator | Drug: GWP42003, Drug: PlaceboContains 100 mg GWP42003 and placebo (excipients only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (24 listed)
- 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:
- Any known or suspected history of depression sufficient to require treatment with antidepressants or disrupt ordinary life at the discretion of the investigator);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GWP42003Also: Cannabidiol, CBD100 mg capsules, PO, BD, 91 days | Drug | 20:1 GWP42003 : GWP42004, GWP42003 and placebo |
| GWP42003Also: Cannabidiol, CBD5 mg capsules, PO, BD, 91 days | Drug | 1:1 GWP42003 : GWP42004 |
| GWP42004Also: delta-9-tetrahydrocannabivarin, THCV5 mg capsules, PO, BD, 91 days | Drug | 1:1 GWP42003 : GWP42004, 20:1 GWP42003 : GWP42004, GWP42004 and placebo |
| Placebo0 mg capsules, QDS, PO, 91 days | Drug | GWP42003 and placebo, GWP42004 and placebo, Placebo |
Primary outcome
The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
43 secondary outcomes
The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment
Time frame: Baseline (Day 1) and End of treatment (Day 92)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27573936Jadoon KA, Ratcliffe SH, Barrett DA, Thomas EL, Stott C, Bell JD, O'Sullivan SE, Tan GD. Efficacy and Safety of Cannabidiol and Tetrahydrocannabivarin on Glycemic and Lipid Parameters in Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Pilot Study. Diabetes Care. 2016 Oct;39(10):1777-86. doi: 10.2337/dc16-0650. Epub 2016 Aug 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GWP42003 and GWP42004 in people with Dyslipidemias and Diabetes Mellitus, Type 2, run by Jazz Pharmaceuticals at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment (time frame: Baseline (Day 1) and End of treatment (Day 92)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.