Real-world efficacy and safety of SGLT2 inhibitor add-on triple therapy in south indian patients with type 2 diabetes mellitus: a 24-week prospective observational cohort study
Abstract
Background: Type 2 diabetes mellitus (T2DM) in South Asian populations is characterised by early-onset disease, visceral adiposity disproportionate to body mass index, and accelerated pancreatic β-cell decline which is collectively termed the Asian Indian Phenotype. This study evaluated the glycaemic, anthropometric, haemodynamic, hepatorenal, and mechanistic effects of adding a sodium-glucose cotransporter-2 (SGLT2) inhibitor to existing Metformin and Glimepiride dual therapy in South Indian patients with suboptimally controlled T2DM.
Methods: This prospective, single-arm observational cohort study (TREND statement for nonrandomised studies followed) enrolled 87 adult South Indian patients with T2DM inadequately controlled on Metformin (≥ 1500 mg/day) and Glimepiride (2-4 mg/day), with HbA1c 7.5-10.0% and eGFR ≥ 60 mL/min/1.73 m². Treatment was allocated at the discretion of the treating physician rather than by randomisation; patients received Dapagliflozin 10 mg (n = 52) or Empagliflozin 10-25 mg (n = 35) for 24 weeks. As an exploratory study, no a priori sample size calculation was performed and findings are considered hypothesis-generating. Continuous variables were assessed for normality (Shapiro-Wilk test and Q-Q plots); intra-group comparisons used the paired t-test with 95% confidence intervals (CIs). Subgroup, correlation, responder, and multivariable regression analyses were prespecified and are exploratory.
Results: HbA1c declined from 8.62 ± 0.74% to 7.71 ±…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 52 participants or records.
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