Unblinding in the trial
This is a double-blind trial. This means that neither the participant nor their doctors will know which treatment they have received.
Participants in the trial take up to a total daily amount of 2000mg (4 capsules) of Immediate Release Metformin or 1200mg (4 capsules) of R/S-Alpha Lipoic Acid or 4 capsules of Placebo.
We only expect unblinding in the trial in rare clinical circumstances. For example, when knowledge of treatment allocation is essential to guide clinical management.
For specific anticipated scenarios with advice to unblind, read this guidance on unblinding clinical scenarios.
UK:
If unblinding is needed, all NHS doctors are able to find out a participant’s allocation through the unblinding process. When unblinding is being considered, is should first be discussed either with the trial team at the recruiting hospital, or with the trial team in the UK (Chief Investigator, Prof Jeremy Chataway or Clinical fellow(s)). All details are found on the participant’s trial card. However, if unblinding is essential for the participant’s immediate management, please proceed to unblind the participant.
You can find out about the unblinding process in this flow diagram.
If you have any questions, please refer to the participation card for local site contact details or out of hours numbers.
To contact the Octopus team (UK):
- Phone: UCLH out of hours emergency number +44 (0)20 3456 7890
- Please ask for Prof. Jeremy Chataway, Dr Sean Apap Mangion or Dr Charles Wade
- Email: mrcctu.octopus@ucl.ac.uk (working hours only)
All NHS doctors can directly access treatment information in an emergency using the link below and entering their GMC number and NHS email address in addition to the participant’s ID number and date of birth. The participant’s ID number can be found on their trial participation card. Unblinding details will be sent to the NHS email address provided.
Australia:
In medical emergencies, this can be performed by any treating doctor as well the participant’s trial site PI, delegated site clinicians, PLATYPUS Country Lead Investigator, Simon Broadley, or Trial Physicians via the website.
Where unblinding is being considered by a treating doctor outside the trial team, the case ideally (although not mandatory) should first be discussed with the PI or delegated clinician at the participant’s PLATYPUS site.
You can find out about the unblinding process in this flow diagram.
If they are unavailable, Professor Simon Broadley can be contacted via the emergency out-of-hours number. These contact details can be found on the trial participation card.
To contact the Platypus team (Australia):
- Phone: Griffith University out of hours emergency number 0466 207 444
- When dialling this number, please ask for Prof. Simon Broadley
- Email: platypus@griffith.edu.au
The requesting doctor must provide the relevant details needed to perform the unblinding:
- Participant trial number and date of birth
- Details of the requesting doctor
- Full name
- Institutional email address*
- AHPRA number
- Reason(s) for the request
*Note: the institutional email address must end in @gov.au or @edu.au. The email provided will be where they will receive the unblinding information.
UNBLINDING SHOULD ONLY BE PERFORMED BY A DOCTOR AND SHOULD ONLY BE CONSIDERED WHERE KNOWLEDGE OF TREATMENT ALLOCATION IS ESSENTIAL TO GUIDE CLINICAL MANAGEMENT.
