Insulin degludec/insulin aspart reduces hypoglycaemia risk in T2D during Ramadan
Insulin degludec/insulin aspart reduced the rates of overall and nocturnal severe hypoglycaemia compared with biphasic insulin aspart 30 in Muslim individuals with type 2 diabetes (T2D) who fast during Ramadan, according to data presented at EASD 2017.
“Hypoglycaemia is the main concern during the month of Ramadan,” said Dr Mohamed Hassanein from the Dubai Health Authority in Dubai, UAE. “[Our findings showed a] big difference in the rates of severe and nocturnal severe hypoglycaemic episodes with [insulin degludec/insulin aspart].”
A total of 263 Muslim patients with T2D who intended to fast were randomized to receive twice-daily insulin degludec/insulin aspart (n=131) or biphasic insulin aspart 30 (n=132). Ninety-three percent of patients were on oral antidiabetic therapy in addition to insulin. After the 20-week treatment initiation, participants were evaluated for blood-glucose confirmed hypoglycaemia during the 4-week Ramadan period and 4 weeks thereafter. [EASD 2017, abstract 159]
Compared with biphasic insulin aspart 30, insulin degludec/insulin aspart reduced the overall rates of symptomatic hypoglycaemia episodes during Ramadan (estimated ratio, 0.38, 95 percent confidence interval [CI], 0.19–0.77; p=0.0070) and at treatment end (estimated ratio, 0.26, 95 percent CI, 0.16–0.44; p<0.0001).
“[This] is really important considering [that subjects were] fasting for an average of 12–16 hours,” said Hassanein.
The same pattern was observed during the nocturnal safety period running between midnight and 6 am, with significant reductions in hypoglycaemia episodes during Ramadan (estimated ratio, 0.26, 95 percent CI, 0.08–0.88; p=0.0304) and at treatment end (estimated ratio, 0.17, 95 percent CI, 0.08–0.38; p<0.0001) with insulin degludec/insulin aspart vs biphasic insulin aspart 30.
The nocturnal safety period is technically a nonfasting phase; however, some individuals still wake up to eat, said Hassanein. “[I]t is important for patients with T2D on insulin to feel [confident] that their risk of hypoglycaemia is low [during this period].”
The time before the end of fast would be the most vulnerable period of a fasting day, Hassanein pointed out, as glucose resources would have been exhausted at this point despite ongoing insulin.
Nonetheless, post hoc analysis further showed that insulin degludec/insulin aspart significantly reduced overall symptomatic hypoglycaemia episodes 2 hours after the predawn meal until the end of fast compared with biphasic insulin aspart 30 (estimated ratio, 0.44, 95 percent CI, 0.21–0.94).
Overall, these findings support the potential benefit of insulin degludec/insulin aspart for managing fasting-induced hypoglycaemia in Muslim patients with T2D, said Hassanein, as a lot of patients from this group prefer to fast during Ramadan due to religious or cultural reasons despite exemptions for medically compromised individuals.