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

NCT01217112 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-10-18

Study results available
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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

Interventions

DRUG

GWP42003

100 mg capsules, PO, BD, 91 days

DRUG

GWP42003

5 mg capsules, PO, BD, 91 days

DRUG

GWP42004

5 mg capsules, PO, BD, 91 days

DRUG

Placebo

0 mg capsules, QDS, PO, 91 days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-05-31
Completion
2012-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217112 on ClinicalTrials.gov