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
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.
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
Vascular Health and Risk Management 2014:10