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    Summary
    EudraCT Number:2013-001140-61
    Sponsor's Protocol Code Number:GWDM1302
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-05
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-001140-61
    A.3Full title of the trial
    A randomised, double blind, placebo controlled, parallel group, dose ranging study of GWP42004 as add on to metformin in the treatment of participants with Type 2 diabetes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GWP42004 as add on to metformin in the treatment of participants with Type 2 diabetes.
    A.4.1Sponsor's protocol code numberGWDM1302
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGW Research Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGW Research Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Research Ltd.
    B.5.2Functional name of contact pointGW Research Ltd. - Switchboard
    B.5.3 Address:
    B.5.3.1Street AddressPorton Down Science Park
    B.5.3.2Town/ citySalisbury
    B.5.3.3Post codeSP4 0JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441980557000
    B.5.5Fax number+441980557111
    B.5.6E-mailinfo@gwpharm.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDelta-9-Tetrahydrocannabivarin
    D.3.2Product code GWP42004
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 28172-17-0
    D.3.9.2Current sponsor codeGWP42004
    D.3.9.3Other descriptive nameTETRAHYDROCANNABIVARIN 9
    D.3.9.4EV Substance CodeSUB107728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 28172-17-0
    D.3.9.2Current sponsor codeGWP42004
    D.3.9.3Other descriptive nameTETRAHYDROCANNABIVARIN 9
    D.3.9.4EV Substance CodeSUB107728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 28172-17-0
    D.3.9.2Current sponsor codeGWP42004
    D.3.9.3Other descriptive nameTETRAHYDROCANNABIVARIN 9
    D.3.9.4EV Substance CodeSUB107728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 - <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
    E.4Principal exclusion criteria
    • 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.
    E.5 End points
    E.5.1Primary 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).
    E.5.1.1Timepoint(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)
    E.5.2Secondary 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
    E.5.2.1Timepoint(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 where indicated
    A Es
    Vital signs
    BDI-II
    C-SSRS - V2, 3, 4 & 5
    ECG - V1 & 5
    Labs
    Physical exam
    Rates of hypoglycaemia
    CWS (UK) - V2, 2 days before V5 & 1, 3 and
    7 days after V5
    Absorption
    Plasma GWP42004 & metabolites - V2 & 5
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal standard of care will resume as clinical evidence of the efficacy of these medicines in this population of participants has yet to be determined.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NIHR Diabetes Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-29
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