MATERIALS AND METHODS: In this up to 33-week, open-label, active-controlled, parallel-group trial, adults [glycated haemoglobin (HbA1c) 7%-10% (53-86 mmol/mol); body mass index ≥20 kg/m(2) ; intent to fast] were randomized (1:1) ≥10 weeks before Ramadan to either switch to once-daily liraglutide (final dose 1.8 mg) or continue pre-trial sulphonylurea at maximum tolerated dose, both with metformin.
PRIMARY ENDPOINT: change in fructosamine, a validated marker of short-term glycaemic control, during Ramadan.
RESULTS: Similar reductions in fructosamine levels were observed for both groups during Ramadan [liraglutide (-12.8 µmol/L); sulphonylurea (-16.4 µmol/L); estimated treatment difference (ETD) 3.51 µmol/L (95% CI: -5.26; 12.28); p = 0.43], despite lower fructosamine levels in the liraglutide group at start of Ramadan. Fewer documented symptomatic hypoglycaemic episodes were reported in liraglutide-treated (2%, three subjects) versus sulphonylurea-treated patients (11%, 18 subjects). No severe hypoglycaemic episodes were reported by either group. Body weight decreased more during Ramadan with liraglutide (ETD: -0.54 kg; 95% CI: -0.94;-0.14; p = 0.0091). The proportion of patients reporting adverse events was similar between groups. Liraglutide led to greater HbA1c reduction [ETD: -0.59% (-6.40 mmol/mol), 95% CI: -0.79; -0.38%; -8.63; -4.17 mmol/mol; p
MATERIALS AND METHODS: A dose-ranging analysis using SKF7® was conducted through a randomized, double-blind, multicentre, placebo-controlled, phase 2 clinical trial involving individuals with obesity (N = 133) between January 2020 and April 2021. The potential percentage of change was assessed in relation to BW, BMI, WC and WHtR.
RESULTS: Average treatment effect estimates (treatment group vs. placebo) show a statistically significant reduction in the percentage of change for BW (mean = -2.915; CI: -4.546, -1.285), BMI (-2.921; CI: -4.551, -1.291), WC (mean = -2.187; CI: -3.784, -0.589) and WHtR (mean = -2.294, CI: -3.908, -0.681) in the group with a total of 750 mg of SKF7® (p
METHODS: We conducted a cross-sectional analysis of data from adults with T2D from 11 Asian countries/regions with structured assessment enrolled in the prospective Joint Asia Diabetes Evaluation (JADE) register between November 2007 and December 2019. Patients receiving insulin and/or injectable glucagon-like peptide-1 receptor agonists were excluded.
RESULTS: Amongst 62 512 patients (mean ± standard deviation age: 57.3 ± 11.8 years; 53.6% men), 54 783 (87.6%) were treated with OGLDs at enrolment. Most received one (37.5%) or two (44.2%) OGLDs. In the entire cohort, 59.4% of treated patients received SU-based therapy with variations amongst countries/regions. Overall, 79.5% of SU regimens were based on SUs plus metformin, and 22.1% on SUs plus dipeptidyl peptidase-4 inhibitors. Among SU users, gliclazide was most commonly prescribed (46.7%), followed by glimepiride (40.0%) and glibenclamide (8.1%). More gliclazide users entered the cohort with glycated haemoglobin levels <53 mmol/mol (7%) than non-gliclazide SU users (odds ratio [OR] 1.09, 95% CI 1.02-1.17), with less frequent self-reported hypoglycaemia in the 3 months before registration (OR 0.81, 95% CI 0.72-0.92; adjusted for sociodemographic factors, cardiometabolic risk factors, complications, use of other OGLDs, country/region and year of registration).
CONCLUSION: In Asia, SUs are a popular OGLD class, often combined with metformin. Good glycaemic control and safety profiles associated with the use of SUs, including gliclazide, support their position as a key treatment option in patients with T2D.
MATERIALS AND METHODS: We conducted a systematic review and meta-analysis of AID-URAI versus AID-RAI. We systematically searched PubMed, Scopus, ProQuest, Web of Science, Cochrane Library, Clinicaltrial.gov, and medRxiv for articles up to 30 October 2024. Percent time-in-range (TIR; 3.9-10 mmol/L), time-below-range (TBR; 3.9- and 3.0-mmol/L), and time-above-range (TAR; >10.0- and 13.9-mmol/L) were extracted. This study was registered in the PROSPERO (CRD42024602279).
RESULTS: Sixteen randomized controlled trials (664 participants) were included in this study. AID-URAI were associated with an increased percentage of TIR, but not clinically significant (pooled mean difference {MD} = 1.07% [95% confidence interval {CI}: 0.11 to 2.02]; I2 = 0%; p = 0.029; high certainty). The favourable effect was consistent in AID systems incorporating automated bolus correction, adults, study duration >4 weeks, and FIASP subgroups. AID-URAI has a 0.35% lower percentage of TBR (<3.9 mmol/L) compared with AID-RAI. There were no significant differences in the risk of diabetic ketoacidosis and severe hypoglycemia between the two groups.
CONCLUSIONS: AID-URAI slightly improves the percentage of TIR and has a good safety profile without increasing the risk of diabetic ketoacidosis and severe hypoglycemia.
MATERIALS AND METHODS: A trial-based cost-effectiveness study with a 6-month time horizon was conducted. Ninety-one participants (intervention, n = 46; usual care, n = 45) across 13 community pharmacies were included. The intervention group received in-depth counselling from pharmacists, in-app prediabetes education modules and peer support, while the usual care group received counselling based on pharmacists' usual practice. The primary outcome was quality-adjusted life years (QALY). Incremental cost-effectiveness ratios (ICER) per QALY gained of the intervention were compared with usual care from healthcare and societal perspectives. Non-parametric bootstrapping was used to examine uncertainty.
RESULTS: At 6months, the QALY achieved was 0.467 (95% CI 0.456 to 0.479) in the intervention group and 0.466 (95% CI 0.451 to 0.482) in the usual care group, resulting in a net gain of 0.005 QALY (95% CI -0.017 to 0.026) in the intervention group. The incremental healthcare and societal costs were US$6.10 (95% CI $5.33 to $6.88) and $10.69 (95% CI $6.03 to $15.35), respectively. From a healthcare perspective, the ICER per QALY gained was $1354, with a probability of 69.2% being cost-effective, while the corresponding figures were $2371 and 67.7% from a societal perspective. Results were below the willingness-to-pay threshold at $11 845 and were robust to sensitivity analyses.
CONCLUSION: A community pharmacy-based and digital health-supported lifestyle intervention to manage prediabetes may be cost-effective compared with usual care in Malaysia over a 6-month period.