Continuous Glucose Monitoring Profiles and Health Outcomes After Dapagliflozin Plus Saxagliptin vs Insulin Glargine
Authors' conclusion
DAPA + SAXA and INS were equally effective in reducing HbA1c at 24 weeks, but people with T2D treated with DAPA + SAXA achieved greater time in range, greater reductions in glycemic excursions and variability, less time with hypoglycemia, and improved patient-reported health outcomes.
Study context
- Population
- Adults with T2D inadequately controlled with metformin ± sulfonylurea; 112 centers in 11 countries
- Participants
- 283 adults
- Comparison
- Dapagliflozin plus saxagliptin vs insulin glargine
- Primary endpoint
- Changes in CGM profiles, HbA1c and PROs
- Follow-up
- 24 weeks
Methodological detailsopen-label, 2-arm, parallel-group, phase 3b, multicentre (112 centers in 11 countries), masked continuous glucose monitoring (CGM), 24-week
- Open-label
- 2-arm
- Parallel-group
- Phase 3b
- Multicentre (112 centers in 11 countries)
- Masked CGM
- 24-week
Primary result
As reported in the abstract
CGM % time in range (>3.9 and ≤10 mmol/L)
P = 0.033
Further findings
| Outcome | Mean difference (%) (95% CI) | P value | |
|---|---|---|---|
| Change from baseline in HbA1c · 24 weeks | −0.12 (−0.37 to 0.12%) | P = 0.33 | |
| −0.4−0.200.2Difference, % (linear scale) |
| Outcome | DAPA + SAXA | INS | P value |
|---|---|---|---|
| Mean amplitude of glycemic excursions · 24 weeksSmaller with DAPA + SAXA | −0.7 ± 0.1 mmol/L | −0.3 ± 0.1 mmol/L | P = 0.017 |
Change from baseline in HbA1c · 24 weeks
- HbA1c changes with DAPA + SAXA similar to INS
Patient-reported outcomes (PROs)
- CGM improvements associated with greater satisfaction, better body weight image, less weight interference and improved mental and emotional well-being
Safety
% time with nocturnal hypoglycaemia (AUC ≤3.9 mmol/L) · 24 weeks · lower with DAPA + SAXA
P = 0.007
Original publication
Continuous Glucose Monitoring Profiles and Health Outcomes After Dapagliflozin Plus Saxagliptin vs Insulin Glargine. J Clin Endocrinol Metab. Published 27 February 2024. doi:10.
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