The ‘Can Do Ramadan’ Study
Research type
Research Study
Full title
A Randomised Controlled Trial for People with Established Type 2 Diabetes during Ramadan: Canagliflozin (Invokana™) vs. standard dual therapy regimen: The ‘Can Do Ramadan’ Study
IRAS ID
182266
Contact name
Melanie Davies
Contact email
Sponsor organisation
University of Leicester
Eudract number
2015-002104-91
Duration of Study in the UK
1 years, 5 months, 3 days
Research summary
There are over one billion Muslims in the world with the majority participating in Ramadan which is an integral part of Islamic identity. Muslims observing Ramadan are required to fast from sunrise to sunset during this holy month. During the summer season Ramadan can take place with the longest hours of daylight which has a greater impact and risk for people with diabetes who fast during this period. Although the Quran exempts “sick” people from the duty of fasting many Muslims with diabetes do not consider themselves to be sick and are keen to fast. The person with diabetes may not discuss fasting with their health care provider (HCP) if they are given generic advice not to fast due to diabetes. There is a lack of evidence available to help guide the management of people with diabetes who wish to observe Ramadan. One of the aims of this study is to determine the potential effects of fasting in people with diabetes on well-being and the management of this condition. Some known side-effects of fasting during Ramadan include low blood sugars (hypoglycaemia), high blood sugars (hyperglycaemia), dehydration which may lead to hospitalisation. There have been significant advances in glucose lowering therapies in type 2 diabetes mellitus (T2DM) and their availability, thus offering a greater choice of therapies to people with diabetes with the potential for supporting safer fasting. Such therapies include the sodium-dependent glucose co-transporter-2 (SGLT2) inhibitors which increase glucose loss through the urine, resulting in lower blood glucose levels, improved diabetes control, weight loss and no hypoglycaemia risk. The present study will determine if the SGLT2 inhibitor Canagliflozin is effective in weight maintenance and improved diabetes control with less hypoglycaemic events compared with an established therapy (sulphonylureas, repaglinide or pioglitazone).
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0009
Date of REC Opinion
9 Mar 2016
REC opinion
Further Information Favourable Opinion