Type 2 diabetes MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Delta-9-Tetrahydrocannabivarin
Product Code: GWP42004
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: N/A
CAS Number: 28172-17-0
Current Sponsor code: GWP42004
Other descriptive
Sponsors
GW Research Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 - 23 - =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Participant is taking or has taken insulin at any point in the year prior to screening (does not include short term use (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 2, 5 and 15 mg twice daily of GWP42004 compared with placebo by assessing the impact of treatment on glycaemic control in the treatment of participants with Type 2 diabetes.;Secondary Objective: To evaluate the efficacy of 2, 5 and 15 mg twice daily of GWP42004 compared with placebo on: • Other measures of glycaemic control • Measures of insulin sensitivity • Measures of beta cell function • Body weight • Body Mass Index (BMI) • Lipid parameters • A marker of inflammation • Cardiovascular parameters • Health economics To assess the safety and tolerability of GWP42004 compared with placebo on: • Adverse Events (AEs) • Vital signs • Depression (Beck Depression Inventory-II [BDI-II]) • Suicidal tendencies (Columbia-Suicide Severity Rating Scale [C-SSRS]) • Electrocardiogram (ECG) • Clinical pathology (haematology and clinical chemistry) • Physical examination • Blood glucose safety (Self-Monitoring of Blood Glucose [SMBG]) • Cannabis withdrawal (Cannabis Withdrawal Scale [CWS]) (UK based participants only) To assess evidence of absorption of GWP42004.;Primary end point(s): To evaluate the efficacy of 2, 5 and 15 mg twice daily of GWP42004 compared with placebo by assessing the change from baseline in glycosylated haemoglobin A 1c (HbA1c).;Timepoint(s) of evaluation of this end point: Assessed at: Visit 1 (Day -7); Visit 2 (Day 1); Visit 3 (Day 29), Visit 4 (Day 57) and Visit 5 (Day 85) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the efficacy of 2, 5 and 15 mg of GWP42004 twice daily compared with placebo on: • Glycaemic Control: o Fasting plasma glucose levels o Glucose response to an Oral Glucose Tolerance Test (OGTT) o Serum fructosamine levels o Number of participants with HbA1c levels <7% (53 mmol/mol) following treatment Insulin related parameters: o Fasting plasma insulin levels o Insulin resistance (by Homeostatic Model Assessment 2 for Insulin Resistance) o Insulin response to OGTT o Pro-insulin o C-peptide o Beta cell function (by Homeostatic Model Assessment 2 for beta cell protection) • BMI • Lipid parameters: o Total cholesterol levels o High Density Lipoprotein-cholesterol levels o Serum triglyceride levels • A marker of inflammation: o High sensitivity C-Reactive Protein levels • Cardiovascular parameters: o Blood pressure • Health economics: o Diabetes Treatment Satisfaction Questionnaire (status version) (DTSQs) o Overall health Visual Analogue Scale (VAS) To assess the safety and tolerability of GWP42004 compared with placebo on: • AEs • Vital signs • BDI-II • C-SSRS • ECG • Laboratory findings • Physical examination • Blood glucose safety (SMBG) o Rates of hypoglycaemia • CWS (UK-based participants only) Evidence of absorption of GWP42004: • Pre- and post-dose plasma levels of GWP42004 and metabolites;Timepoint(s) of evaluation of this end point: Efficacy Fasting plasma glucose - V2, 3, 4 & 5 Glucose response to OGTT - V2 & 5 Serum fructosamine - V2 & 5 Participants with HbA1c <7% - V3, 4 & 5 Fasting plasma insulin - V2, 3, 4 & 5 Insulin resistance - V2, 3, 4 & 5 Insulin response to OGTT - V2 & 5 Pro-insulin - V2 & 5 C-peptide - V2 & 5 B-cell function - V2, 3, 4 & 5 BMI - V2, 3, 4 & 5 Total cholesterol - V2 & 5 HDL-cholesterol - V2 & 5 Serum triglyceride - V2 & 5 CRP- V2 & 5 Blood pressure - V2, 3, 4 & 5 DTSQ - V2, 3, 4 & 5 Health VAS - V2, 3, 4 & 5 Safety- V1, 2, 3, 4 & 5 except | — |
Countries
Belgium, Poland, Romania, United Kingdom
Contacts
Public ContactGW Research Ltd. - Switchboard
GW Research Ltd.
Outcome results
None listed