A Study of GWP42004 as Add on to Metformin in the Treatment of Participants With Type 2 Diabetes

NCT02053272 | Completed Phase 2

• 2 other identifiers: GWDM13022013-001140-61
• Study Type: interventional
• Target: 207
• Locations: 2 countries
• Sites: 25

Brief Summary

A study to compare the change in glycaemic control in participants with Type 2 diabetes when treated with GWP42004 or placebo as add-on therapy to metformin over a period of 12 weeks. The safety and tolerability of GWP42004 compared with placebo will also be assessed.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Glycaemic control; Delta-9-tetrahydrocannabivarin; Cannabinoids

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the end of treatment in mean glycosylated haemoglobin A1c (HbA1c) level.

  At baseline and at the end of treatment, a fasting blood sample is taken for measurement of HbA1c levels. Values are 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.

  Baseline (Day 1) and End of treatment (Day 85)

Secondary Outcomes (24)

• Change from baseline to the end of treatment in mean fasting plasma glucose concentration.

  Baseline (Day 1) and End of treatment (Day 85)

• Change from baseline to the end of treatment in mean serum glucose concentration two hours post glucose challenge (Oral Glucose Tolerance Test [OGTT])

  Baseline (Day 1) and End of treatment (Day 85)

• Change from baseline to the end of treatment in mean serum fructosamine concentration.

  Baseline (Day 1) and End of treatment (Day 85)

• Change from baseline to the end of treatment in the number of participants with a HbA1c level below 7%.

  Baseline (Day 1) and End of treatment (Day 85)

• Change from baseline to the end of treatment in mean fasting plasma insulin concentration.

  Baseline (Day 1) and End of treatment (Day 85)

Study Arms (4)

2 mg GWP42004 bid

ACTIVE COMPARATOR

Licaps® size double zero (Size 00) hard gelatin capsules containing 2 mg GWP42004 dissolved in excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks.

Drug: GWP42004

5 mg GWP42004 bid

ACTIVE COMPARATOR

Licaps® size double zero (Size 00) hard gelatin capsules containing 5 mg GWP42004 dissolved in excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks.

Drug: GWP42004

15 mg GWP42004 bid

ACTIVE COMPARATOR

Licaps® size double zero (Size 00) hard gelatin capsules containing 15 mg GWP42004 dissolved in excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks.

Drug: GWP42004

Placebo

PLACEBO COMPARATOR

Licaps® size double zero (Size 00) hard gelatin capsules containing excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks.

Drug: Placebo

Interventions

GWP42004 DRUG

The total dose administered within any 24-hour interval will be two capsules (typically 12 hours apart).

Also known as: Delta-9-tetrahydrocannabivarin

15 mg GWP42004 bid; 2 mg GWP42004 bid; 5 mg GWP42004 bid

Placebo DRUG

The total dose administered within any 24-hour interval will be two capsules (typically 12 hours apart).

Also known as: Placebo control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study (see Section 15.2).
• 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 enrolment (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).
• Participant is able (in the investigators opinion) and willing to comply with all study requirements.
• Participant is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
• Participant is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.

You may not qualify if:

• Participant is taking or has taken insulin at any point in the last year (does not include short term use (\<10 days) to treat acute events).
• Participant is taking or has taken anti-diabetic treatment (other than metformin) 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 of suspected history of:
• Alcohol or substance abuse.
• 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 (within three months of screening) blood loss (including blood donation).
• 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.
• Has significantly impaired renal function as evidenced by a creatinine clearance lower than 40 mL/min at Visit 1.
• Has significantly impaired hepatic function at Visit 1 (alanine aminotransferase (ALT) levels \>5x upper limit of normal (ULN) or total bilirubin (TBL) levels \> 2x ULN). If the ALT or aspartate aminotransferase (AST) levels are \>3x ULN and the TBL levels \>2x ULN (or International Normalised Ratio (INR) \>1.5), then this participant should not enter the study.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (25)

Diabol SRL

Brasov, 500365, Romania

Location

Nicodiab SRL

Bucharest, 010507, Romania

Location

Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"

Bucharest, 010825, Romania

Location

Institutul National de Diabet

Bucharest, 020475, Romania

Location

Centrul Medical 'Sanatatea Ta' SRL

Bucharest, 020614, Romania

Location

ArtMedical Clinic

Bucharest, 021107, Romania

Location

Societatea Civila Medicala dr. Paveliu

Bucharest, 050538, Romania

Location

Consultmed SRL

Iași, 700547, Romania

Location

Cabinet Medical Individual Diabet Nutritie si Boli Metabolice

Maramures, 430123, Romania

Location

Grandmed SRL

Oradea, 410159, Romania

Location

Spitalul Judetean de Urgente Satu Mare

Satu Mare, 440055, Romania

Location

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, 550245, Romania

Location

Gagiu D. Remus Cabinet Medical Individual

Târgovişte, 130083, Romania

Location

Mediab SRL Diabet Zaharat

Târgu Mureş, 540142, Romania

Location

Avondale Surgery

Chesterfield, Derbyshire, S40 4TF, United Kingdom

Location

Hull and East Yorkshire Hospitals NHS Trust

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE5 4QF, United Kingdom

Location

Aintree University Hospitals NHS Foundation Trust

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Strensall Medical Practice

York, North Yorkshire, YO32 5UA, United Kingdom

Location

Churchill Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Hathaway Surgery

Chippenham, Wiltshire, SN14 6GT, United Kingdom

Location

Avenue Surgery

Warminster, Wiltshire, BA12 9AA, United Kingdom

Location

St Chad's Surgery

Bath, BA3 2UH, United Kingdom

Location

Barts and The London NHS Trust

London, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 3, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

RO (14); GB (11)