Efficacy and safety of adding a fourth oral antidiabetic drug versus metformin dose escalation in patients with type 2 diabetes inadequately controlled on triple oral combination therapy ( EFFORT ): A 24‐week, randomized, open‐label, multicenter trial
Authors' conclusion
Oral quadruple therapy achieved greater glycaemic and metabolic improvement without compromising safety, compared with metformin uptitration, supporting its role as an intensification strategy.
Study context
- Population
- Adults with T2D with HbA1c 7.0–9.0% despite oral triple therapy with metformin plus a thiazolidinedione (TZD), SGLT2i or DPP-4ievaluable
- Participants
- 193 adults
- Comparison
- Adding a fourth oral antidiabetic drug vs metformin uptitration
- Quadruplen = 145
- Metformin uptitrationn = 48reference
- Primary endpoint
- Change in HbA1c
- Follow-up
- Week 24
Methodological detailsopen-label, multicentre, 24-week
- Open-label
- Multicentre
- 24-week
Primary result
As reported in the abstract
HbA1c decrease from baseline
P = 0.002
Secondary outcomes
HbA1c ≤7.0% achieved
P = 0.006
Insulin resistance and albuminuria
- Insulin resistance improved only with quadruple therapy, accompanied by reduced albuminuria
Safety
- Adverse events were mild and comparable between groups
Original publication
Efficacy and safety of adding a fourth oral antidiabetic drug versus metformin dose escalation in patients with type 2 diabetes inadequately controlled on triple oral combination therapy ( EFFORT ): A 24‐week, randomized, open‐label, multicenter trial. Diabetes Obes Metab. Published 3 February 2026. doi:10.
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