Dapagliflozin or Saxagliptin in Pediatric Type 2 Diabetes
Authors' conclusion
Dapagliflozin, but not saxagliptin, showed significant improvement in A1C compared with placebo. Nonserious headaches were more common in participants treated with dapagliflozin than in those receiving placebo.
Study context
- Population
- Patients aged 10 to 17 years with uncontrolled T2D (A1C 6.5 to 10.5%) receiving metformin, insulin, or both
- Participants
- 81 / 88 / 76
- Comparison
- Dapagliflozin or saxagliptin vs placebo
- Dapagliflozinn = 81
- Saxagliptinn = 88
- Placebon = 76reference
- Primary endpoint
- Change in A1C
- Follow-up
- Week 26
Methodological detailsphase 3, placebo-controlled, 26-week extension, 1:1:1 randomisation, re-randomisation at week 14 to continue dose or up-titrate
- Phase 3
- Placebo-controlled
- 26-week extension
- 1:1:1 randomisation
- Re-randomisation at week 14 to continue dose or up-titrate
Primary result
As reported in the abstract
Adjusted mean change in A1C
Each group vs placeboDifference, percentage points (95% CI)P value
Dapagliflozin
−1.03(−1.57 to −0.49)
P < 0.001Saxagliptin
−0.44(−0.93 to 0.05)
P = 0.078Safety
AEs · 52 weeks
Serious AEs · 52 weeks
Severe hypoglycemia · 52 weeks
| Outcome | Dapagliflozin | Saxagliptin | Placebo |
|---|---|---|---|
| Headache (most common AE) · 52 weeks | 14.8% | — not stated in the abstract | 5.3% |
— not stated in the abstract
Headache (most common AE) · 52 weeks
- Most events mild; none serious or resulted in discontinuation
Original publication
Dapagliflozin or Saxagliptin in Pediatric Type 2 Diabetes. NEJM Evid. Published 4 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →