GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes

NCT01217112 | Completed Phase 2 Results

• 2 other identifiers: GWMD10922010-020458-33
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Dyslipidemias; Diabetes Mellitus, Type 2

Keywords

Dyslipidemias; Diabetes; Liver Fat; Body Fat

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Baseline (Day 1) and End of treatment (Day 92)

Study Arms (5)

GWP42004 and placebo

ACTIVE COMPARATOR

Contains GWP42004 5 mg and placebo (excipients only)

Drug: GWP42004; Drug: Placebo

1:1 GWP42003 : GWP42004

ACTIVE COMPARATOR

Contains 5 mg each of GWP42003 and GWP42004

Drug: GWP42003; Drug: GWP42004

20:1 GWP42003 : GWP42004

ACTIVE COMPARATOR

Contains 100 mg GWP42003 and 5 mg GWP42004

Drug: GWP42003; Drug: GWP42004

Placebo

PLACEBO COMPARATOR

Contains excipients only

Drug: Placebo

GWP42003 and placebo

ACTIVE COMPARATOR

Contains 100 mg GWP42003 and placebo (excipients only)

Drug: GWP42003; Drug: Placebo

Interventions

GWP42003 DRUG

100 mg capsules, PO, BD, 91 days

Also known as: Cannabidiol, CBD

20:1 GWP42003 : GWP42004; GWP42003 and placebo

GWP42004 DRUG

5 mg capsules, PO, BD, 91 days

Also known as: delta-9-tetrahydrocannabivarin, THCV

1:1 GWP42003 : GWP42004; 20:1 GWP42003 : GWP42004; GWP42004 and placebo

Placebo DRUG

0 mg capsules, QDS, PO, 91 days

GWP42003 and placebo; GWP42004 and placebo; Placebo

Eligibility Criteria

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

You may qualify if:

• 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);

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (5)

Woolpit Health Centre

Bury Saint Edmonds, IP30 9QU, United Kingdom

Location

Mount Farm Surgery

Bury Saint Edmonds, IP32 7EW, United Kingdom

Location

University of Nottingham, Medical School at Derby, Royal Derby Hospital

Derby, DE22 3DT, United Kingdom

Location

James Paget University Hospital

Gorleston-on-Sea, Norfolk, NR31 6LA, United Kingdom

Location

MAC UK Neuroscience Ltd.

Manchester, M32 0UT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27573936 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Diabetes Mellitus, Type 2; Diabetes Mellitus; Fatty Liver

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Mr Richard Potts, Clinical Operations Director
• Organization: GW Research Ltd.

rp@gwpharm.com

0044 1223266800

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: October 7, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 18, 2022
• Results First Posted: January 20, 2014

Record last verified: 2022-09

Locations

GB (5)