T2D: dapagliflozin + saxagliptin vs dapagliflozin or saxagliptin as add-on to metformin

  • Rosenstock J & al.
  • Diabetes Obes Metab
  • 30 May 2019

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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  • In patients with uncontrolled type 2 diabetes (T2D), triple therapy with once-daily dapagliflozin (DAPA), saxagliptin (SAXA) and metformin (MET) significantly improved glycaemic control and reduced body weight compared with dual therapy with addition of either monocomponent to MET and was generalled well tolerated.

Why this matters

  • Current treatment guidelines differ in perspectives on the most appropriate time to initiate and advance therapy with a combination of agents given simultaneously in patients with T2D.

Study design

  • 832 patients with T2D were randomly assigned to receive DAPA+SAXA+MET (n=273), DAPA+MET (n=276) and SAXA+MET (n=283).
  • Primary outcome: change in glycated hemoglobin (HbA1c) at 24 weeks.
  • Secondary outcomes: the proportion of patients achieving HbA1c
  • Funding: AstraZeneca.

Key results

  • At 24 weeks, DAPA+SAXA+MET vs DAPA or SAXA+MET groups had a significant reduction in:
    • HbA1c level (−1.03±0.06% vs −0.63±0.06% vs −0.69±0.06%; P<.0001 for both comparison>
    • FPG level (−28±2 vs −20±2 mg/dL; P=.0135 vs −13±2 mg/dL; P<.0001>
  • Higher proportion of patients in DAPA+SAXA+MET group (adjusted response rate [aRR], 41.6%; 95% CI, 36.0-47.1%) achieved HbA1c
  • Reduction in body weight was significantly higher with DAPA+SAXA+MET vs SAXA+MET (−2.0±0.2 vs −0.4±0.2 kg; P<.0001>
  • Reduced estimated glomerular filtration rate (4.1%), urinary tract infection (2.4%) and pollakiuria (2.4%) were the most commonly reported adverse events with DAPA+SAXA+MET.


  • Long-term benefits of triple therapy vs dual therapy were not assessed.

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