New findings showed that adults with type 2 diabetes treated with Victoza, in combination with metformin, experienced similar improvements in blood glucose control while fasting during Ramadan (four weeks) compared with sulfonylurea (SU) plus metformin.
People treated with Victoza also demonstrated significantly better weight loss and fewer confirmed hypoglycaemic episodes compared with those treated with sulfonylurea during Ramadan. Findings from the LIRA-Ramadan study were presented at the 75th Annual Scientific Sessions of the American Diabetes Association (ADA) in Boston, Massachusetts.
The 33-week, open-label, randomised study showed that Victoza sustained blood glucose control during four weeks of Ramadan, with similar reductions in fructosamine levels compared with sulfonylurea (-12.8 µmol/L vs. -16.4 µmol/L; estimated treatment difference [ETD] 3.51 µmol/L [-5.26;12.28]; P=0.43). Testing fructosamine allows the effectiveness of diabetes treatment to be reliably evaluated after a couple of weeks. During Ramadan, patients treated with Victoza experienced fewer confirmed hypoglycaemic episodes compared with people treated with sulfonylurea (2.0% vs. 4.3%), even though the Victoza group had lower fructosamine concentration at the start of Ramadan. In addition, greater weight loss was observed in people treated with Victoza during Ramadan vs. sulfonylurea (-1.43 kg/-3.1 lbs vs. -0.89 kg/-2.0 lbs; ETD - 0.54 kg/-1.2 lbs [-0.94/-2.07;-0.14/-0.31]; P=0.0091).
“Fasting during Ramadan presents unique medical challenges for people living with type 2 diabetes and their healthcare providers,” said Dr Sami Azar, Professor of Medicine at the American University of Beirut Medical Center, Beirut, Lebanon and principal investigator of the LIRA-Ramadan trial. “Prolonged fasting, often followed by large nighttime meals, can affect blood glucose levels and result in severe hypoglycaemia and hyperglycaemia. To help minimise these risks, physicians and people with type 2 diabetes should consider evaluating and discussing diabetes management plans in advance of Ramadan.”
More than 50 million Muslims worldwide with diabetes fast during Ramadan, the majority of which have been estimated to have type 2 diabetes. Muslims with type 2 diabetes who fast have an estimated 7.5–fold increased risk of severe hypoglycaemia and a five-fold increased risk of severe hyperglycaemia (requiring hospitalisation) during Ramadan, which takes place 18 June – 17 July this year.
In the LIRA-Ramadan study, people treated with Victoza from baseline to the end of Ramadan were more likely to achieve an HbA1c target of <7% with no confirmed hypoglycaemic episodes compared with sulfonylurea (53.9% vs. 23.5%; OR 3.80 [2.24;6.46]; P<0.0001). Also, people treated with Victoza compared with sulfonylurea experienced significantly greater weight loss (-5.40 kg/-11.9 lbs vs. -1.46 kg/-3.2 lbs; ETD -3.94 kg/-8.7 lbs [-4.54/-10.0;-3.33/-7.3]; P<0.0001), had significantly greater improvements in HbA1c (-1.24% vs. -0.65%; ETD -0.59% [-0.79;-0.38]; P<0.0001), were more likely to achieve the target level of HbA1c <7% (57.1% vs. 26.4%; OR 3.71 [2.18;6.30]; P<0.0001), and experienced significant reductions in fructosamine levels (- 39.6 µmol/L vs. -29.3 µmol/L; ETD -10.3 µmol/L [-18.7;-1.89]; P=0.0165).
The percentage of patients experiencing adverse events (AEs) during Ramadan was similar in the Victoza and sulfonylurea groups (23.7% vs. 20.9%), with gastrointestinal side effects more common with Victoza treatment (10.5% vs. 3.7%). Overall, a low incidence of severe AEs was observed (Victoza, 1.3% vs. sulfonylurea, 0%). The most common AEs seen during the entire study period were gastrointestinal (Victoza, 56.7% vs. sulfonylurea, 9.4%), and these included nausea, diarrhoea, vomiting, abdominal pain and abdominal distension.