Efficacy of Dapagliflozin + Sitagliptin + Metformin Versus Sitagliptin + Metformin in T2DM Inadequately Controlled on

Awadhesh Kumar Singh1, Ashok Kumar Das2, L Sreenivasa Murthy3

  • 1GD Hospital and Diabetes Institute, 139 A, Lenin Sarani Rd, Bowbazar, Kolkata, West Bengal, 700013, India. drawadheshkumarsingh@gmail.com.

Advances in Therapy
|December 5, 2024
PubMed
Abstract

Insights

A new triple fixed-dose combination (FDC) of dapagliflozin, sitagliptin, and metformin extended release (XR) significantly improved glycemic control in type 2 diabetes patients compared to a dual FDC. The triple FDC demonstrated superior efficacy with a comparable safety profile.

Area of Science:

  • Endocrinology and Metabolism
  • Pharmacology
  • Clinical Trial Research

Background:

  • Limited data hinders fixed-dose combination (FDC) adoption in diabetes management.
  • This study addresses the safety and efficacy of a triple FDC (dapagliflozin + sitagliptin + metformin XR) versus a dual FDC (sitagliptin + metformin XR).
  • The evaluation focuses on type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control on metformin monotherapy.

Purpose of the Study:

  • To assess the efficacy and safety of a triple FDC compared to a dual FDC in T2DM patients.
  • To evaluate glycemic control improvements, including HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (PPG).
  • To compare weight changes and the proportion of patients achieving target HbA1c levels.

Main Methods:

  • A randomized controlled trial involving 274 T2DM patients.
  • Patients were randomized to receive either the triple FDC (dapagliflozin 10 mg + sitagliptin 100 mg + metformin XR 1000 mg) or the dual FDC (sitagliptin 100 mg + metformin XR 1000 mg).
  • Treatment duration was 16 weeks, with outcome measures including HbA1c, FPG, PPG, weight, and achievement of HbA1c < 7.0%.

Main Results:

  • The triple FDC group showed a significantly greater reduction in HbA1c (ETD -0.65%, P < 0.0001) compared to the dual FDC group.
  • Significant reductions in FPG (ETD -15.42 mg/dL), PPG (ETD -30.39 mg/dL), and weight (ETD -1.47 kg) were observed with the triple FDC.
  • 54% of patients on the triple FDC achieved HbA1c < 7.0% versus 29.9% on the dual FDC, with comparable adverse event incidence.

Conclusions:

  • The triple FDC (dapagliflozin + sitagliptin + metformin XR) offers superior glycemic control compared to the dual FDC (sitagliptin + metformin XR) in T2DM patients.
  • The enhanced glycemic response was achieved with a comparable safety and tolerability profile.
  • This triple FDC represents an effective treatment option for T2DM patients with poor glycemic control on metformin monotherapy.

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