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Manchester Diabetes Centre contributes to global study on Ramadan fasting

Manchester Diabetes Centre has contributed to findings of a global study that demonstrated that patients fasting during Ramadan, and receiving the treatment vildagliptin were less likely to experience hypoglycaemia than those receiving gliclazide.

Hypoglycaemia describes a low level of sugar in the blood and is commonly associated with diabetes.  It mainly occurs if someone with diabetes takes too much insulin, uses certain glucose lowering drugs such as the sulphonylureas, misses a meal or exercises too hard.  The symptoms include feeling hungry, trembling or shaking, sweating, confusion, difficulty concentrating, which can lead to road traffic accidents and in severe cases life-threatening coma.

Ramadan, which starts this year on Saturday 28th June 2014, is the ninth month of the Islamic lunar calendar, and a time when Muslims fast during the hours of daylight.  Healthy people can fast with little long-term impact on their health, as long as they have a sufficient and well-balanced intake of food and fluids after dusk and before dawn.  The major risk of fasting during Ramadan is hypoglycaemia.  For this reason, it is recommended that patients with diabetes seek advice from their GP prior to fasting.

The study published in the medical journal, Vascular Health and Risk Management recruited 557 patients, with type 2 diabetes, who had previously been treated with metformin and any sulphonylurea medication.  At Manchester Diabetes Centre, the highest recruiting site in the UK, 12 patients were randomised into the study.

The patients were randomised to receive either metformin and vildagliptin, or metformin and gliclazide, a sulphonylurea.  They had their blood pressure, heart rate, and weight recorded, and undertook blood tests at the clinic where they were prescribed the medication.  This was repeated before the start of Ramadan and, again, within four weeks of the end of the Ramadan fasting period.  Participants were also provided with a glucometer and diary, to enable them to test and record their sugar levels, and monitored via frequent telephone calls from one of the Diabetes Research Network nurses throughout the study.

This study is the first large randomised international study with Vildagliptin, which is in-line with a previous study from India and Malaysia using Sitagliptin. The STEADFAST study showed that vildagliptin was an effective, safe and well-tolerated treatment in patients with type 2 diabetes during Ramadan. In particular the proportion of patients reporting severe (<3.9 mmol/L) hypoglycaemic events was ~50% lower with vildagliptin than gliclazide (3.0% vs. 7.0%, respectively).  The incidence of any hypoglycaemic event was also lower (6.0% with vildagliptin and 8.7% with gliclazide).

The study was funded by Novartis, and supported by the National Institute for Health Clinical Research Network.

Reference

Hassanein M, Abdallah K, Schweizer A.  A double-blind randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST Study.  Vascular Health and Risk Management 2014:10 319-326.