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Background <p>Achieving glycemic control while preserving renal function is critical in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). Fixed-dose combinations (FDCs) may improve efficacy, tolerability, and adherence.</p> Objective <p>This real-world study evaluated the effectiveness and safety of dual FDC (Glimepiride + Metformin) and triple FDC (Metformin + SGLT2i + DPP4i) in Indian adults with T2DM and CKD.</p> Methods <p>Multicentre, retrospective chart review with prospective follow-up and physician survey across 150 centres. Adults with T2DM and CKD (KDIGO G1–G3b with kidney damage or eGFR &lt; 60&#xa0;mL/min/1.73 m2 and/or UACR ≥ 30&#xa0;mg/g) receiving either FDC were included. The primary endpoint was change in HbA1c; secondary endpoints were changes in renal biomarkers (creatinine, UACR), electrolytes, weight, adverse events, and physician-reported outcomes.</p> Results <p>Among 549 patients (mean age 58.6&#xa0;years), mean HbA1c decreased from 9.39% to 7.45% (Δ –1.94%, 95% CI –2.07 to –1.81; <i>p</i> &lt; 0.0001). The proportion achieving HbA1c &lt; 7% rose from 0% to 38.4%. Mean fasting glucose decreased by 53.6&#xa0;mg/dL and postprandial glucose by 99.2&#xa0;mg/dL (<i>p</i> &lt; 0.0001). Serum creatinine declined from 4.11 to 2.58&#xa0;mg/dL (Δ –1.53&#xa0;mg/dL; <i>p</i> &lt; 0.0001), and mean UACR from 465 to 272&#xa0;mg/g (Δ –193&#xa0;mg/g; <i>p</i> &lt; 0.001). Electrolyte abnormalities improved (hypernatremia 80% → 36%; hypercalcemia 76% → 25%; hyperkalemia 82% → 30%). Weight changes occurred in 49%. Dose titration was required in 31.9%, mainly for renal or lipid parameters. Adverse events (&lt; 10%) included volume depletion (<i>n</i> = 23), nocturia/genitourinary infections (<i>n</i> = 12), ketonuria (<i>n</i> = 5), and pyuria (<i>n</i> = 2); none required hospitalization. Physicians reported improved efficacy and adherence in ~ 80–90% of patients, with 43% showing total compliance. Prescribing rationale included reducing CKD events (83.1%), glycemic control (66.3%), adherence (61.7%), and slowing renal decline (57%).</p> Conclusion <p>Dual and triple FDCs demonstrated effectiveness and tolerability in improving both glycemic and renal outcomes in T2DM patients with CKD, supported by real-world physician feedback.</p>

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Glimepiride & metformin FDC along with metformin + dapagliflozin + sitagliptin FDC in T2DM patients with high-risk CKD -Indian real world evidence study: GRACE CKD

  • 期刊论文

  • 发表日期：

    2025年11月20日

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  • L. Sreenivasa Murthy,
  • Anuj Jain,
  • Lavanya Katakam,
  • Arpandev Bhattacharyya,
  • Naseem Sait,
  • Mahesh Chavan,
  • Manoj Chitale,
  • Sonali Bhojane,
  • Ashish Sardar,
  • Ashish Prasad

摘要

Background

Achieving glycemic control while preserving renal function is critical in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). Fixed-dose combinations (FDCs) may improve efficacy, tolerability, and adherence.

Objective

This real-world study evaluated the effectiveness and safety of dual FDC (Glimepiride + Metformin) and triple FDC (Metformin + SGLT2i + DPP4i) in Indian adults with T2DM and CKD.

Methods

Multicentre, retrospective chart review with prospective follow-up and physician survey across 150 centres. Adults with T2DM and CKD (KDIGO G1–G3b with kidney damage or eGFR < 60 mL/min/1.73 m2 and/or UACR ≥ 30 mg/g) receiving either FDC were included. The primary endpoint was change in HbA1c; secondary endpoints were changes in renal biomarkers (creatinine, UACR), electrolytes, weight, adverse events, and physician-reported outcomes.

Results

Among 549 patients (mean age 58.6 years), mean HbA1c decreased from 9.39% to 7.45% (Δ –1.94%, 95% CI –2.07 to –1.81; p < 0.0001). The proportion achieving HbA1c < 7% rose from 0% to 38.4%. Mean fasting glucose decreased by 53.6 mg/dL and postprandial glucose by 99.2 mg/dL (p < 0.0001). Serum creatinine declined from 4.11 to 2.58 mg/dL (Δ –1.53 mg/dL; p < 0.0001), and mean UACR from 465 to 272 mg/g (Δ –193 mg/g; p < 0.001). Electrolyte abnormalities improved (hypernatremia 80% → 36%; hypercalcemia 76% → 25%; hyperkalemia 82% → 30%). Weight changes occurred in 49%. Dose titration was required in 31.9%, mainly for renal or lipid parameters. Adverse events (< 10%) included volume depletion (n = 23), nocturia/genitourinary infections (n = 12), ketonuria (n = 5), and pyuria (n = 2); none required hospitalization. Physicians reported improved efficacy and adherence in ~ 80–90% of patients, with 43% showing total compliance. Prescribing rationale included reducing CKD events (83.1%), glycemic control (66.3%), adherence (61.7%), and slowing renal decline (57%).

Conclusion

Dual and triple FDCs demonstrated effectiveness and tolerability in improving both glycemic and renal outcomes in T2DM patients with CKD, supported by real-world physician feedback.