Type 1 diabetes: long-term efficacy and safety of dapagliflozin

  • Mathieu C & al.
  • Diabetes Obes Metab
  • 20 Apr 2020

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • In patients with type 1 diabetes (T1D), dapagliflozin as an adjunct to insulin demonstrated long-term reductions in haemoglobin A1c (HbA1c) and body weight but increased the risk of diabetic ketoacidosis (DKA) compared with placebo.

Why this matters

  • Findings are consistent with previous long-term studies of sodium glucose cotransporter 2 inhibitors in patients with T1D and type 2 diabetes.

Study design

  • This long-term extension of the DEPICT-2 study included 813 adults with T1D (HbA1c, 7.5-10.5%) randomised (1:1:1) to receive dapagliflozin 5 mg, 10 mg, or placebo; 88.2% completed the study.
  • Funding: AstraZeneca.

Key results

  • After 52 weeks, dapagliflozin 5 and 10 mg vs placebo group demonstrated reductions in HbA1c (difference [95% CI],−0.20% [−0.34 to −0.06%] and −0.25% [−0.38 to −0.11%], respectively), and body weight (difference, −4.42% [−5.19 to −3.64%] and −4.86% [−5.63 to −4.08%], respectively).
  • The proportion of participants achieving an HbA1c reduction of ≥0.5% without a severe hypoglycemia event was higher in the dapagliflozin 5 and 10 mg groups vs. placebo (32.7%, 32.2%, and 20.8%, respectively)
  • Serious adverse events were reported in the dapagliflozin 5 mg, 10 mg, and placebo groups (32 [11.8%], 19 [7.0%], and 16 [5.9%], respectively).
  • The proportion of participants with ≥1 hypoglycaemic (85.2%, 86.7%, and 87.1%) and severe hypoglycaemic events (8.9%, 9.6%, and 8.5%) were similar for dapagliflozin 5 mg, 10 mg, and placebo, respectively.
  • The proportion of participants with an event adjudicated as definite DKA was higher in both the dapagliflozin 5 and 10 mg groups vs. placebo (4.1%, 3.7%, and 0.4%, respectively); this risk was manageable and all events resolved with treatment.

Limitations

  • Insulin was not titrated using a protocol-mandated algorithm.