SUMMARYAimsTo assess, in a real-world setting, the effect of vildagliptin compared with sulphonylurea (SU) treatment on hypoglycaemia in Muslim patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan.MethodsThis multinational, non-interventional study, conducted in Asia and the Middle East, included Muslim adult patients with T2DM who received treatment with vildagliptin or SU as add-on to metformin or monotherapy. During a ∼16-week observation period, data were collected up to 6 weeks before and 6 weeks after Ramadan fasting. The primary study objective was to compare the proportion of patients with ≥ 1 hypoglycaemic event (HE) during fasting.ResultsOf > 1300 patients enrolled in the study, 684 were treated with vildagliptin and 631 with SUs. Significantly fewer patients experienced ≥ 1 HE with vildagliptin compared with those receiving SUs (5.4% vs. 19.8%, respectively; p < 0.001); no vildagliptin-treated patients reported a grade 2 HE, vs. 4 SU-treated patients (p = 0.053). Mean HbA1c changes from baseline were vildagliptin: –0.24%, SUs: +0.02% (p < 0.001). Mean body weight reductions from baseline were vildagliptin: –0.76 kg, SUs: –0.13 kg (p < 0.001). A higher proportion of SU-treated patients experienced adverse events (AEs) compared with vildagliptin (22.8% vs. 10.2%). This difference was driven by hypoglycaemia as the most common AE.ConclusionsIn this real-world study of fasting Muslim patients with T2DM, vildagliptin was associated with significantly fewer hypoglycaemic episodes compared with SU therapy. This outcome is particularly meaningful when viewed in the context of good glycaemic and weight control observed in vildagliptin-treated patients. Vildagliptin was well tolerated in this patient population.Linked Comment:Ahmed. Int J Clin Pract 2013; 67: 933–4.

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ORION evaluated the safety and effectiveness of Gla-300 in insulin-treated people with T2DM before, during and after Ramadan, in a real-world setting. Methods: This prospective, observational study across 11 countries included participants with T2DM treated with Gla-300 in pre-Ramadan, Ramadan and post-Ramadan periods. The primary endpoint was the percentage of participants experiencing !1 event of severe and/or symptomatic documented hypoglycaemia with self-monitored plasma glucose (SMPG) 70 mg/dL during Ramadan. Secondary endpoints included change in HbA 1c and insulin dose and adverse events (AEs). Results: The mean ± SD number of fasting days was 30.1 ± 3.2. The percentage of participants experiencing !1 event of severe and/or symptomatic documented hypoglycaemia (SMPG 70 [<54] mg/dL) was low in the pre-Ramadan (2.2% [0.8%]), Ramadan (2.6% [0%]) and post-Ramadan (0.2% [0%]) periods. No participants reported severe hypoglycaemia during Ramadan or post-Ramadan; one participant reported severe hypoglycaemia in pre-Ramadan. HbA 1c fell pre-to post-Ramadan, and Gla-300 daily dose (mean ± SD) was reduced pre-Ramadan to Ramadan (from 25.6 ± 11.9 U/0.32 ± 0.14 U/kg to 24.4 ± 11.5 U/0.30 ± 0.13 U/kg). Incidence of AEs was 5.5%. Conclusions: In ORION, people with T2DM treated with Gla-300 who fasted during Ramadan had a low risk of severe/symptomatic hypoglycaemia and improved glycaemic control.

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The DAR Global survey of Ramadan-fasting during the COVID-19 pandemic aimed to describe the characteristics and care in participants with type 2 diabetes (T2D) with a specific comparison between those <65 years and !65 years.Methods: Participants were consented to answer a physician-administered questionnaire following Ramadan 2020. Impact of COVID-19 on the decision of fasting, intentions to fast and duration of Ramadan and Shawal fasting, hypoglycaemia and hyperglycaemia events

Objectives In the current study, we aimed at evaluating the effect of a culturally-based pre-Ramadan education program (PREP) on glycemic control, weight, adherence to post-sunset physical activity, perception of hypoglycemia, and anti-diabetic medication dose adjustment during Ramadan fasting in type 2 diabetics. Study design A total of 1008 type 2 Diabetes patients were offered a culturally-based PREP in addition to the standard of care, two months before Ramadan. A retrospective interview one month after Ramadan compared the fasting experience of PREP attendees (470 patients) with those who merely received standard of care (538 patients) (Non-PREP). Results Ramadan fasting improved glycemic control with a correlation between HbA1c percent reduction and the number of fasting days (r = −0.290, p = 0.007). More HbA1c and weight percent reduction were observed in PREP attendees compared to the Non-PREP group (−14.8% ± 9.3 vs. -5.4% ± 5.4; p < 0.001; and − 1.96% ± 5.4 vs. -0.39% ± 2.8; p < 0.001, respectively). More commitment to night prayers in the PREP attendees compared to the Non-PREP group, (85.5% prayed >20 nights vs 28.4%; p < 0.001) with more HbA1c and weight percent reduction in the those who performed the prayers more than 20 nights compared to those who performed no prayers (−11.69% ± 8.8 vs −6.28% ± 6.4, p < 0.001; and − 2.76% ±5.1 vs 1.35% ±1.8, p < 0.001, respectively). More perception of true hypoglycemia was associated with PREP attendance (p0.046), insulin treatment (p0.000), and reduction of antidiabetic medication dosage (p0.004). Repeated lowering of antidiabetic medications doses with sequential downsizing of meals' portions, and appetite was reported. Conclusion Ramadan fasting was beneficial for people with type 2 diabetes with reduction of HbA1c in correlation with the number of fasting days. Contrasting PREP with Non-PREP participants discovered better HbA1c and weight reduction in the former group even with equal number of fasting days. PREP participants performed more Taraweeh night prayers. The more the prayer nights the more decline of HbA1c and weight was observed. PREP improved perception and response to hypoglycemia with low-dosing of antidiabetic medications, especially insulin.

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