GLP-1 Receptor Agonist Used in the Treat 4 Ramadan Study
The Treat 4 Ramadan study used liraglutide as the GLP-1 receptor agonist, comparing it to a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes fasting during Ramadan 1.
Study Design and Patient Population
The Treat 4 Ramadan trial was a randomized controlled trial conducted at two UK sites that enrolled 99 adults with established type 2 diabetes who intended to fast during Ramadan 1. The patient population had a mean age of 52 years and a body mass index (BMI) of 32 kg/m² 1. All participants were on mono or dual oral therapy prior to the study 1.
Key Findings with Liraglutide
The study demonstrated that liraglutide was well tolerated and effective during Ramadan fasting, with superior outcomes compared to sulphonylurea therapy 1. Specifically:
HbA1c reduction: Liraglutide achieved a 0.3% reduction in HbA1c from a baseline of 7.7%, while the sulphonylurea group showed no change (+0.02%) at 12 weeks (adjusted coefficient -0.41,95% CI -0.83,0.01, p = 0.05) 1
Weight management: Significant reductions in weight were observed with liraglutide compared to sulphonylurea 1
Blood pressure: Diastolic blood pressure was significantly reduced in the liraglutide group 1
Hypoglycemia safety: There were no episodes of severe hypoglycemia in either group, but self-recorded episodes of blood glucose ≤3.9 mmol/l were significantly lower with liraglutide (incidence rate ratio 0.29,95% CI 0.19,0.41, p < 0.0001) 1
Clinical Significance for Ramadan Fasting
Liraglutide's glucose-dependent mechanism of action makes it particularly suitable for Ramadan fasting, as it carries minimal hypoglycemia risk when used alone 2. This is critical during the prolonged fasting hours when patients abstain from food and drink from dawn to sunset 3. The study demonstrated that more patients in the liraglutide group achieved the composite endpoint of HbA1c < 7%, no weight gain, and no severe hypoglycemia, though this did not reach statistical significance (OR 4.08,95% CI 0.97,17.22, p = 0.06) 1.
Treatment Satisfaction
Treatment satisfaction was comparable across both treatment groups, indicating that liraglutide was well accepted by patients observing Ramadan 1. This is important given that adherence to therapy during religious fasting periods can be challenging 3.
Context Within Current Guidelines
Modern glucose-lowering drugs such as GLP-1 analogues are designed to improve glycemic control while minimizing the risk of hypoglycemia, making fasting during Ramadan more acceptable and manageable for patients with type 2 diabetes 3. The Treat 4 Ramadan study provided important evidence supporting the use of liraglutide specifically during this religious observance 1.