GWP42004 in Type 2 diabetes
Research type
Research Study
Full title
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
IRAS ID
142216
Contact name
Melanie Davies
Contact email
Sponsor organisation
GW Research Ltd.
Eudract number
2013-001140-61
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N.A
Research summary
This clinical study is being conducted by GW Research Ltd to determine the efficacy and safety of the drug GWP42004 as an add on treatment to oral metformin compared with placebo by assessing the impact of treatment on glycaemic control in the treatment of participants with Type 2 diabetes.
This is a Phase II, randomised, double blind, placebo controlled, parallel group, dose ranging study. Participants enrolled will receive 2 mg, 5 mg, 15 mg twice daily of GWP42004 or placebo. Each treatment group will consist of 50 participants.
The study will last up to 14 weeks, and the treatment period is 12 weeks. The study includes 5 visits at the study clinic and 3 visits via telephone if applicable.Participants will have to self-monitor their blood glucose levels the day before each visit, recording the information in a diary. They will also self-monitor their blood glucose levels any time they feel they have experienced a hypoglycaemic event. Other assessments include BMI measurements as well as questionnaires, monitoring adverse events, vital signs, electrocardiogram and blood/urine samples.
Eligible participants will not be required to stop taking their current medication, oral metformin.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0423
Date of REC Opinion
30 Dec 2013
REC opinion
Further Information Favourable Opinion