Mathieu C, et al. - In patients with inadequately controlled type 1 diabetes (glycated hemoglobin [HbA_1c] 7.5–10.5%), researchers tested the effectiveness and safety of dapagliflozin as adjunct therapy to adjustable insulin. In patients with type 1 diabetes, dapagliflozin as adjunct therapy to adjustable insulin was well tolerated and improved glycemic control with no increase in hypoglycemia compared to placebo but with more diabetic ketoacidosis (DKA) events.

Methods

• It was a 24-week, double-blinded, phase 3 clinical trial (DEPICT-2).
• For this investigation, study participants were randomized 1:1:1 to dapagliflozin 5 mg (n=271), dapagliflozin 10 mg (n=270), or placebo (n=272) plus insulin.
• According to self-monitored glucose readings, local guidance, and individual circumstances, insulin dose was adjusted by investigators.

Results

• According to the findings obtained, baseline characteristics were balanced between treatment groups.
• It was observed that dapagliflozin significantly reduced HbA_1c (primary outcome; difference vs placebo: dapagliflozin 5 mg -0.37% [95% CI -0.49, -0.26], dapagliflozin 10 mg –0.42% [-0.53, -0.30]), total daily insulin dose (-10.78% [-13.73, -7.72] and -11.08% [-14.04, -8.02], respectively), and body weight (-3.21% [-3.96, -2.45] and -3.74% [-4.49, -2.99], respectively) (P < 0.0001 for all) at week 24.
• Findings revealed that mean interstitial glucose, amplitude of glucose excursion and percent of readings within target glycemic range (> 70 to ≤ 180 mg/dL) compared with placebo were significantly improved.
• Compared with placebo, more subjects receiving dapagliflozin achieved a reduction in HbA_1c ≥ 0.5% without severe hypoglycemia.
• Researchers found that adverse events were reported for 72.7%, 67.0%, and 63.2% of patients receiving dapagliflozin 5 mg, dapagliflozin 10 mg, and placebo, respectively.
• Data reported that hypoglycemia, including severe hypoglycemia, was balanced between groups.
• More adjudicated definite DKA events were observed with dapagliflozin: 2.6%, 2.2%, and 0% for dapagliflozin 5 mg, dapagliflozin 10 mg, and placebo, respectively.