Efficacy and tolerability of initial triple combination therapy with metformin, dapagliflozin and saxagliptin compared with stepwise add‐on therapy in drug‐naïve patients with type 2 diabetes ( TRIPLE ‐ AXEL study): A multicentre, randomized, 104‐week, open‐label, active‐controlled trial
Primary resultResult — go to the resultRisk difference 22.0 95% CI 3.0–40.8Authors' conclusion
Among newly diagnosed patients with T2D, initial TCT effectively lowered HbA1c levels with higher tolerability and safety than SAT for 104 weeks, suggesting a novel strategy for initial combination therapy in T2D patients.
Study context
- Population
- Drug-naïve, newly diagnosed T2D with HbA1c ≥8.0%, <11.0%randomized
- Participants
- 105 participants
- Comparison
- Initial triple combination therapy vs stepwise add-on therapy
- Primary endpoint
- Proportion achieving HbA1c <6.5% without hypoglycaemia, weight gain ≥5% or discontinuation of drugs due to adverse events
- Follow-up
- Week 104
Methodological detailsmulticentre, open-label, active-controlled, 104-week
- Multicentre
- Open-label
- Active-controlled
- 104-week
Primary result
As reported in the abstract
Risk difference
22.0
95% CI 3.0–40.8
P = 0.027
By group
TCTvs SAT
risk difference 22.0 (95% CI 3.0–40.8); P = 0.027
Further findings
HbA1c <6.5% · week 104
Least squares mean change, %
| Outcome | TCT | SAT |
|---|---|---|
| HbA1c change from baseline (least squares mean) · week 104 | −2.56 | −2.75 |
HbA1c change from baseline (least squares mean) · week 104
- HbA1c reduction similar between the groups
Safety
Hypoglycaemia, weight gain or discontinuation of drugs
P < 0.001
Adverse events
- Triple combination therapy (TCT) was well-tolerated and had fewer adverse events than SAT
Original publication
Efficacy and tolerability of initial triple combination therapy with metformin, dapagliflozin and saxagliptin compared with stepwise add‐on therapy in drug‐naïve patients with type 2 diabetes ( TRIPLE ‐ AXEL study): A multicentre, randomized, 104‐week, open‐label, active‐controlled trial. Diabetes Obes Metab. Published 10 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →