CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
GWP42003 +3 moredrug
Likely dose
GWP42003 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01217112
NCT01217112Phase 2Completed

A Randomised, Double Blind, Placebo Controlled, Parallel Group, Pilot Study of 1:1 and 20:1 Ratio of Formulated GWP42003 : GWP42004 Plus GWP42003 and GWP42004 Alone in the Treatment of Dyslipidaemia in Subjects With Type 2 Diabetes

Jazz Pharmaceuticals·interventional·Posted Oct 8, 2010·Updated Oct 18, 2022

In Brief

A Phase 2 clinical trial evaluating GWP42003, GWP42004, and 1 other intervention for Dyslipidemias and Diabetes Mellitus, Type 2. Completed, enrolled 62 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.7 years ago

Interventions

GWP42003drug

100 mg capsules, PO, BD, 91 days

GWP42003drug

5 mg capsules, PO, BD, 91 days

GWP42004drug

5 mg capsules, PO, BD, 91 days

Placebodrug

0 mg capsules, QDS, PO, 91 days