GWP42004 as add on to metformin in the treatment of participants with Type 2 diabetes.
- Conditions
- Therapeutic area: Diseases [C] - Hormonal diseases [C19]MedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 diabetes
- Registration Number
- EUCTR2013-001140-61-GB
- Lead Sponsor
- GW Research Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
• Male or female participants aged 18 years or above
• Clinically diagnosed with Type 2 diabetes
• Participants receiving oral metformin (= 1000 mg per day) as anti-diabetic treatment who have received a stable dose for at least three months prior to screening (Visit 1) and willing to maintain a stable dose for the duration of the trial
• HbA1c level of >7% - =9 % (53 - 74.9 mmol/mol)
• BMI of>25 - <40 (>23 - <40 for Asian populations)
• No changes in diet or exercise for three months prior to study entry and participant agrees to keep stable for the duration of the study
• Capable of complying with the study requirements and completing the study (in the opinion of the investigator)
• Willing and able to give written informed consent
• Willing and able to comply with all study requirements
• 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• Participant is taking or has taken insulin at any point in the year prior to screening (does not include short term use (<10 days) to treat acute events)
• Participant is taking or has taken anti-diabetic treatment (other than metformin) at any point in the three months prior to screening
• Any concomitant medications which, in the opinion of the investigator, could affect the primary endpoint should remain stable or not be prescribed in the one month prior to Visit 1 or during the study period.
• Any known or suspected history of:
o alcohol or substance abuse
o epilepsy or recurrent seizures
• Participants receiving treatment with antidepressants or under observation for depression.
• BDI-II item 9 score of 1, 2 or 3
• Participant who has significant history of suicidal ideation or self-harm.
• Recent blood loss (including blood donation) within three months of screening
• Haemolytic anaemia
• Genetic abnormality in haemoglobin molecule (e.g. sickle cell anaemia)
• Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator
• Any known or suspected hypersensitivity to cannabinoids (CBs) or any of the excipients of the Investigational Medicinal Products (IMPs)
• Has significantly impaired renal function as evidenced by a creatinine clearance lower than 40mL/min at Visit 1
• Has significantly impaired hepatic function at Visit I (alanine aminotransferase [ALT] levels >5X upper limit of normal [ULN] or total bilirubin [TBL] levels> 2X ULN). If the ALT or aspartate aminotransferase levels are >3X ULN and the TBL levels >2X ULN (or International Normalised Ratio > 1.5), then this participant should not enter the study
• Female participants of child bearing potential and male participants whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective double barrier contraception
• Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
• Participants who have received an IMP within the 12 weeks prior to the screening visit
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, may influence the result of the study, or the participant's ability to participate in the study
• Following a physical examination, the participant has any abnormalities that, in the opinion of the investigator would prevent the participant from safe participation in the study
• Unwilling to abstain from donation of blood during the study
• Participants who have previously undergone bariatric surgery
• Travel outside the country of residence planned during the study, unless the participant has prior permission from the embassy of the destination country
• Participants previously randomised into this study
• The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the 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