Dapagliflozin or saxagliptin, which is better for children with type 2 diabetes?
USA: A phase III T2NOW trial comparing dapagliflozin or saxagliptin in pediatric type 2 diabetes revealed that Dapagliflozin (Farxiga) lowered HbA1c by 1.03 percentage points more than placebo, while saxagliptin (Onglyza) showed no significant reduction versus placebo.
The study findings were presented at the European Association for the Study of Diabetes annual meeting and published in NEJM Evidence.
There is an increasing incidence of type 2 diabetes (T2D) in children and adolescents, but treatment options are limited. To explore more options, William V. Tamborlane, Yale University, New Haven, CT, and colleagues conducted a 26-week, phase 3 trial with a 26-week extension among patients (10 to 17 years of age) with uncontrolled type 2 diabetes (A1C 6.5 to 10.5%) receiving insulin, metformin, or both.
Participants were randomly assigned in a ratio of 1:1:1 to 5 mg of dapagliflozin (N=81), 2.5 mg of saxagliptin (N=88), or placebo (N=76). Patients in active treatment groups having A1C ≥7% at week 12 were further randomly assigned 1:1 at week 14 to continue the dose or up titrate to a higher dose of 10 mg of dapagliflozin or 5 mg of saxagliptin. The primary endpoint of the study was determined as the change in A1C at week 26. Safety assessment was done over 52 weeks.
The study led to the following findings:
- At week 26, the difference versus placebo in adjusted mean change in A1C was −1.03 percentage points for dapagliflozin and −0.44 percentage points for saxagliptin.
- Adverse events (AEs) and serious AEs occurred in 72.8% and 8.6% of patients receiving dapagliflozin, 69.3% and 8.0% of patients receiving saxagliptin, and 71.1% and 6.6% of patients receiving placebo.
- Severe hypoglycemia occurred in 4.9%, 4.5%, and 7.9% of patients in each group, respectively.
- Over 52 weeks, the most common AE was headache (dapagliflozin 14.8%; placebo 5.3%).
- Most events were mild and none was considered serious or resulted in discontinuation.
"Dapagliflozin showed significant improvement in A1C compared with placebo but not saxagliptin," the researchers wrote. "Nonserious headaches were more common in patients treated with dapagliflozin than in those receiving placebo."
Reference:
The study titled, "Dapagliflozin or Saxagliptin in Pediatric Type 2 Diabetes," was published in NEJM Evidence. DOI: https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300210
