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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Natasha
Wileman
Specialty: Diabetes, Primary sub-specialty: Type 2 UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus
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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) and 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).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Unable, in the opinion of the Investigator, and unable to provide informed consent2. Aged ≤ 25 years old3. Established T2DM (≤ 3 months) on medication for fewer than 8 weeks prior to enrolment4. HbA1c ≤7 and ≥10.5% (if on monotherapy) and ≤6.5 and ≥9.5% (if on dual therapy)5. Individuals not intending to fast for a minimum of 10 consecutive days during the holy month of Ramadan6. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. The latter includes avoiding sex, hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study, or not heterosexually active. Furthermore, subjects who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study. Women of childbearing potential must have a negative urine pregnancy test at baseline.7. Suffer from terminal illness8. Have renal disease that requires immunosuppressive therapy, dialysis or transplant9. Have nephrotic syndrome or inflammatory renal disease10. Have an estimated glomerular filtration rate (eGFR) <60ml/min/1.73m2 at screening11. Have serum creatinine levels >132.6μmol/L for men or >123.8μmol/L for women12. Impaired liver function (ALAT ≥ 2.5 times upper limit of normal)13. Known Hepatitis B antigen or Hepatitis C antibody positive14. Clinically significant active cardiovascular disease (including history of myocardial infarction, unstable angina,previous revascularization procedure or cerebrovascular accident) within the past 6 months before screening15. Have uncontrolled hypertension (defined as systolic blood pressure ≥180mm/Hg and diastolic ≥100mm/Hg in the supine position after >5minutes rest with confirmed compliance to antihypertensive medication)16. Heart failure (NYHA class III and IV) at the discretion of the investigator17. Previous history of recurrent major hypoglycaemia as judged by the study clinician18. Known or suspected allergy to the study product19. Receipt of any investigational drug within four weeks prior to this study20. Has had previous treatment with a GLP-1 receptor agonist, DPP-IV inhibitor, insulin, or another SGLT2 inhibitor within 12 weeks of screening21. Have severe and enduring mental health problems22. Are not primarily responsible for their own care23. Are receiving insulin therapy24. Type 1 diabetes25. Any contraindication to sulphonylureas, repaglinide and/or pioglitazone26. Have severe irritable bowel disorder27. Have hereditary glucose-galactose malabsorption28. Have primary renal glycosuria29. Patients who have participated in another study of an investigational medicinal product in the last 3 months
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Natasha
Wileman
The study is sponsored by University of Leicester and funded by Janssen Pharmaceuticals.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
