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3. Results and 40.6 days post-Ramadan. While no dose modifications
in gliclazide MR treatment were observed during the study,
3.1. Patients one patient reported a change in their diabetic treatment (ex-
cept gliclazide MR) during Ramadan (addition of insulin dete-
A summary of the disposition of patients is provided in mir), and four patients reported changes after Ramadan (one
Fig. 1B. Out of a total of 1244 recruited patients, 1214 patients patient stopped metformin, one patient added then stopped
were included in the final analysis set. Thirty patients were insulin, and two patients added linagliptin). The mean (±SD)
excluded from the final analysis for reasons including non- dose of gliclazide MR in the study was 74.0 ± 26.8 mg. Overall,
compliance with inclusion/exclusion criteria and withdrawal 94.9% of patients were treated with 60 mg gliclazide MR
of consent. Of the 1214 patients examined at the inclusion (65.7% on gliclazide MR 60 mg, 6.9% on gliclazide MR 90 mg
visit (V0), 1160 (95.6%) completed the study by attending the and 22.3% on gliclazide MR 120 mg). Treatment adherence
end of study visit (V1). The majority of patients who withdrew during Ramadan was high (99.5%) (Supplementary Table 2).
from the study did so due to non-medical reasons (n = 44/54
patients). Forty-seven patients attended unscheduled visits 3.4. Hypoglycaemia
during the study. Among these patients, only one attended
an unscheduled visit due to hypoglycaemia over the entirety A summary of all HEs reported in the study is provided in
of the study. The remaining visits were classed as regular vis- Table 2. The proportion of patients reporting 1 symptomatic
its (40 patients) or were due to other reasons (7 patients). HE during Ramadan (confirmed or suggestive) was low (2.2%).
The main baseline characteristics are presented in Table 1. The proportion of patients reporting 1 symptomatic HE
Patients had a mean (±standard deviation [SD]) HbA 1c value of (confirmed or suggestive) before and after Ramadan was very
7.5 ± 0.9% at baseline, and a mean (±SD) T2DM disease dura- low (0.2% pre-Ramadan and 0.3% post-Ramadan). The propor-
tion of 5.4 ± 5.7 years. Approximately half of the patients tion of patients reporting 1 confirmed HE (symptomatic or
(46.7%) were listed as being active workers (either full or asymptomatic) during Ramadan was also low (1.6%). Con-
part-time). The majority of included patients (81.8%) were firmed HEs during Ramadan occurred at a mean ± SD of 8.3
considered to be moderate to low risk according to IDF-DAR ± 4.7 h after last food intake and at a mean of 10.5 ± 6.0 h after
guidelines [6]. Around a quarter of patients (24.5%) were last intake of gliclazide MR.
advised not to fast by their treating physicians. A large pro- Overall, 2.3% of patients experienced 1 HE of any type
portion of patients were receiving one antidiabetic treatment during Ramadan. The vast majority of patients with HEs
(gliclazide MR) at baseline (40.8%) (Fig. 2). Among them, 2.8% reported eating 2 meals per day (Supplementary Table 3).
were receiving gliclazide MR 30 mg, 77.8% gliclazide MR No patients reported any severe HEs throughout the entire
60 mg, 3.7% gliclazide MR 90 mg and 15.8% gliclazide MR duration of the study. Patients treated with gliclazide MR
120 mg. Over 60% of patients reported moderate to intermedi- 90 mg or 120 mg at baseline did not have higher rates of hypo-
ate physical activity. glycaemia when compared with those receiving a 60 mg dose
(Supplementary Table 4).
3.2. Nutritional habits and fasting during Ramadan
3.5. HbA 1c and FPG
Depending on the country, the number of fasting days ran-
ged from 29 to 30 days, and the number of fasting hours ran- HbA 1c and FPG values were examined at visits V0 and V1
ged between 13.5 and 15.5 h per day. Patients fasted for a (Fig. 3A). A significant HbA 1c reduction of 0.3% was observed
mean (±SD) of 28.7 ± 3.5 days during Ramadan with a mean between both study visits (p < 0.001). In addition, a significant
fasting duration of 14.7 ± 1.5 h per day (Supplementary FPG reduction of 9.7 mg/dL was also observed (p < 0.001). A
Table 1). Of 1214 patients, around a third (375 patients) chan- higher proportion of patients had an HbA 1c value <7.5% at
ged their meal type compared with the pre-Ramadan period. V1 versus V0 (Fig. 3B).
A total of 193 patients who changed their meal type (51.5%
[15.9% of the total study population]) reported eating more 3.6. Other safety outcomes
carbohydrates during Ramadan. While 494 of the 1,214
patients (40.7%) broke their fast during Ramadan, only 62 3.6.1. Physical examination
(5.1%) broke the fast for more than three consecutive days. Significant reductions in body weight ( 0.5 kg) and BMI
2
Of the 62 patients breaking their fast for three consecutive ( 0.2 kg/m ) were recorded between visits V0 and V1
days, only three broke their fast due to hypoglycaemia. (p < 0.001) (Fig. 3C). Mean (±SD) systolic blood pressure (V0:
Other reasons that patients broke their fast included ‘‘non- 131.2 ± 14.0 mmHg; V1: 129.9 ± 13.0 mmHg), diastolic blood
medical reasons” (45 patients) and ‘‘other medical reasons‘‘ pressure (V0: 80.3 ± 8.5 mmHg; V1: 79.5 ± 8.0 mmHg), and
(14 patients). heart rate (V0: 80.3 ± 9.8 bpm; V1: 79.3 ± 9.7 bpm) values were
comparable between pre- and post-Ramadan visits.
3.3. Exposure to study medication
3.6.2. AEs (other than HEs)
Patients were treated with gliclazide MR for at least 90 days A total of 47 AEs were reported in 34 patients over the entire
prior to the study observation period. The mean study obser- study, with 35 AEs occurring in 24 patients during Ramadan
vation period was 104.8 days (3.5 months) with an average of (Supplementary Table 5). These comprised mainly vertigo,
35.5 days pre-Ramadan, 28.7 fasting days during Ramadan gastrointestinal disorders, infections, nervous system disor-