Dual add‐on therapy of gemigliptin and dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone: The SOLUTION 2 study
Authors' conclusion
These results suggest that the addition of GEMI + DAPA to metformin as triple combination therapy was effective, safe and well-tolerated, especially for T2D patients who experienced poor glycaemic control on metformin alone.
Study context
- Population
- T2D patients with inadequate glycaemic control on a stable dose of metformin for ≥8 weeks
- Participants
- 469 patients
- Comparison
- Gemigliptin + dapagliflozin dual add-on to metformin vs gemigliptin or dapagliflozin single add-on
- Gemigliptin (GEMI) + dapagliflozin (DAPA)n = 157
- GEMIn = 156reference
- DAPAn = 156reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsdouble-blind, double-dummy, active-controlled, parallel-group, phase 3
- Double-blind
- Double-dummy
- Active-controlled
- Parallel-group
- Phase 3
Primary result
As reported in the abstract
GEMI + DAPA
−1.34
least square mean · %
GEMI
−0.90
least square mean · %
DAPA
−0.78
least square mean · %
Difference, % (95% CI)P value
GEMI + DAPAvs GEMI
−0.44(−0.58% to −0.31%)
P < 0.01GEMI + DAPAvs DAPA
−0.56(−0.69% to −0.42%)
P < 0.01Further findings
Responders achieving HbA1c <7%
Responders achieving HbA1c <6.5%
Safety
- Incidence of adverse events similar across groups, with low incidence of hypoglycaemia, urinary tract infection and genital infection
Original publication
Dual add‐on therapy of gemigliptin and dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone: The SOLUTION 2 study. Diabetes Obes Metab. Published 8 July 2024. doi:10.
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