Real-world evidence on the effectiveness and safety of gliclazide extended release treatment in Indian patients with type 2 diabetes undergoing Ramadan fast: an analysis from the global DIA-RAMADAN study

Abstract

Backgroud. Glycaemic imbalance, especially hypoglycaemia, is one of the greatest risks for patients with type 2 diabetes mellitus (T2DM) during Ramadan fasting. This paper outlines the efficacy and safety of gliclazide extended-release (XR) in Indian patients with T2DM enrolled in the global DIA-RAMADAN study. Methods. Adults (aged ≥ 18 years) with T2DM who chose to fast during Ramadan and received a gliclazidebased regimen once daily for 90 days before Ramadan were included in the study. Baseline and end-of-study visits were conducted 6-8 weeks before and 4-6 weeks after Ramadan, respectively. The primary outcome was the incidence of ≥ 1 symptomatic hypoglycaemic event (HE). Changes in glycated haemoglobin (HbA 1c ), fasting plasma glucose (FPG), and body weight were secondary outcomes. Results. Among 246 Indian patients enrolled in the study, most (78.9%, n = 194) were at moderate/low risk as per the International Diabetes Federation and Diabetes and Ramadan guidelines. Most patients (69.1%) received gliclazide XR as monotherapy, and the rest received gliclazide XR with metformin or other antidiabetic therapy. Significant reductions in HbA 1c (−0.5 ± 0.8%, P < 0.001) and FPG (−21.8 ± 59.4 mg/dL, P < 0.001) levels were observed but the slight reduction in body weight was not statistically significant (−0.3 ± 3.7 kg, P = 0.614) in patients post-Ramadan. Overall, no HE was reported in Indian patients with T2DM during Ramadan fasting. Conclusion. Overall, the effectiveness and safety of gliclazide XR in Indian patients were consistent with that observed in the global cohort. Gliclazide XR significantly reduced HbA1c with no incidence of hypoglycaemic events in Indian patients with type 2 diabetes undergoing Ramadan fast, suggesting that gliclazide

Effects of Ramadan Fasting on Glycaemic Control Among Patients with Type 2 Diabetes: Systematic Review and Meta-analysis of Observational Studies

“…Table 2 shows the baseline characteristics of the 12 included studies. Given the predominance of Muslim communities, most of the studies were conducted in Middle Eastern countries [11,[20][21][22][23][24][25][26], with the exception of two studies conducted in Pakistan, three studies in South Asia (Pakistan and India) [27][28][29] and one study in Southeast Asia (Singapore) [14]. The age range of the investigated T2D patients varied widely in and across studies, ranging from 18 to 80 years and from 24 to 95 years in some studies [23,26].…”

“…The classification of age groups also varied between studies, and the proportion of young participants with T2D was around 20-40% in some studies [21,22,27]. However, approximately half of the studies did not report age group classifications and represented the data based on the mean of the total population, even though the included age group was C 18 years [11,14,[24][25][26]28].…”

“…Patients had several comorbidities, including hypertension, cardiovascular disease and hyperlipidemia and nerve damage; these were not reported in some studies [21,22,26,27]. More than half of the studies did not report the season, and the temperature was estimated based on the Ramadan year, which varied between autumn and summer seasons [14,21,23,24,[26][27][28][29].…”

“…Twelve studies reported the impacts of RF on HbA1c (%) in patients with T2D (RF, n = 4667; before fasting, n = 5001) [11,14,[20][21][22][24][25][26][27][28][29]. The forest plot shows that HbA1c was significantly improved in individuals after RF (WMD = 0.55, CI 0.33-0.77, P \ 0.00001), compared to before fasting.…”

“…Fasting Blood Glucose/Fasting Plasma Glucose Of the 12 selected studies, five studies reported changes in FBG level measured in milligrams per decilitre (RF, n = 3167; before fasting, n = 3038 mg/dl) [11,20,21,27,28]. The pooled analysis showed that RF significantly improved the level of FBG (WMD 12.42, 95% CI 6.46-18.38; P \ 0.0001), compared to before fasting.…”