- Adding dapagliflozin (DAPA) to insulin was associated with better glycemic control and greater reductions in body weight compared with placebo in patients with inadequately controlled type 1 diabetes (T1D).
Why this matters
- Less than one-third of patients with T1D have disease that is optimally controlled.
- 28-week extension of the DEPICT-2 study, which initially randomly assigned 815 patients with T1D to either DAPA or placebo.
- Approximately 83% of the initially randomly assigned patients enrolled and completed the extension phase.
- Reductions in HbA1c and body weight were assessed at 52 weeks.
- Adverse events were also assessed at 52 weeks to determine safety.
- Funding: AstraZeneca.
- At 52 weeks, DAPA was associated with reductions in HbA1c with the 5 mg (difference vs placebo: −0.20%; 95% CI, −0.34% to −0.06%) and 10 mg (difference vs placebo: −0.25%; 95% CI, −0.38% to −0.11%) doses.
- Noticeable reductions in body weight were also observed with the 5 mg DAPA (−4.42%; 95% CI, −5.19% to −3.64%) and 10 mg DAPA (−4.86%; 95% CI, −5.63% to −4.08%) doses.
- Rates of definite diabetic ketoacidosis were higher in the DAPA-treated groups with 5 mg (4.3%) and 10 mg (3.7%) compared with placebo (0.4%).
- The lack of a “protocol-mandated insulin titration algorithm” that matches real-world clinical practice.