Ramadan fasting feasible despite insulin glargine/lixisenatide use in Muslims with T2D
13 Apr 2021
byAudrey Abella
Muslim individuals with type 2 diabetes (T2D) who received a fixed-ratio combination (FRC) of insulin glargine 100 U/mL and the GLP-1 RA* lixisenatide (iGlarLixi) were able to fast for the most part of the Ramadan month, with a low incidence of hypoglycaemia and favourable glycaemic control, according to the wave 1 results of the SoliRam** study.
Most Muslims with diabetes still prefer to fast during Ramadan owing to religious principles. [Diabetes Res Clin Pract 2021;doi:0.1016/j.diabres.2021.108674] However, this comes with an increased risk of hypoglycaemia during Ramadan (10.4 percent), which is more than twice the risk observed pre-Ramadan (4.9 percent). [https://idf.org/e-library/guidelines/165-idf-dar-practical-guidelines-2021.html, accessed April 13, 2021; Diabetes Res Clin Pract 2019;151:275-284]
“[Our] interim results … suggest that iGlarLixi may be a suitable treatment option for people with T2D who intend to fast during Ramadan,” noted Dr Mohamed Hassanein from the Dubai Hospital, UAE, in his poster presentation.
To evaluate the safety and efficacy of iGlarLixi FRC before, during, and after*** the Ramadan fast in a real-world setting, Hassanein and his team evaluated 155 Muslims with T2D (mean age 58.4 years, 54 percent male, baseline HbA1c 8.35 percent) who had taken iGlarLixi for ≥3 months before study inclusion and intend to fast for ≥15 days during Ramadan. Of these, 90 percent had taken noninsulin antihyperglycaemic medications at baseline, the most common being biguanides and sulphonylureas (79 percent and 54 percent, respectively). SoliRam shall be performed during Ramadan 2020 and 2021 (waves 1 and 2, respectively). The current analysis is based on wave 1 findings. [ENDO 2021, abstract P16-10]
Almost all (98.7 percent) participants fasted for 25–30 days (94 percent fasted for the entire Ramadan period). The decision to fast was mostly driven by personal reasons (51 percent). Primary reasons for breaking fast were travel, pre-existing conditions, adverse events (AEs), hypoglycaemia, and menstrual period.
Pre-Ramadan, 43 percent of participants took iGlarLixi at breakfast, while the rest either had it around lunch (34 percent) or dinner time (23 percent). During Ramadan, most (90 percent) had their iGlarLixi injections administered at Iftar (ie, evening meal).
The iGlarLixi doses administered across the pre-Ramadan, Ramadan, and post-Ramadan phases were similar (mean, 24.8, 23.8, and 24.9 U, respectively).
Only a few participants were documented to have ≥1 severe and/or symptomatic hypoglycaemia (ie, plasma glucose [PG] <70 mg/dL) during pre-Ramadan, Ramadan, and post-Ramadan (n=2, 3, and 0, respectively).
Improvements in glycaemic control and body weight were also observed between the pre- and post-Ramadan periods, as reflected by the mean reductions in HbA1c (−0.8 percent), fasting PG (−24.4 mg/dL), and body weight (−1.8 kg).
The incidence of AEs was low (5.8 percent) and were not tied to iGlarLixi. No serious AEs, treatment discontinuations owing to AEs, or deaths were reported.
“[It is important to note that] SoliRam wave 1 [participants had] advanced age, long disease duration, poor glycaemic control, and important diabetes-related complications. [Yet,] despite using an intensified treatment regimen including iGlarLixi FRC QD, most were able to fast safely for the entire Ramadan, [with low] hypoglycaemia incidence rates … from pre-Ramadan to Ramadan,” said Hassanein.
“[Moreover,] glycaemic control improved during the study, and there was a reduction in body weight after the Ramadan period,” he added.
Taken together, these findings imply that iGlarLixi may be used in this patient setting with minimal risk of severe hypoglycaemia. The complete results including wave 2 data are anticipated to substantiate the current findings.