Efficacy and safety of pioglitazone, empagliflozin and glimepiride as third‐line agents in patients with type 2 diabetes inadequately controlled with metformin and DPP ‐4 inhibitors: A multicentre, phase 4 randomized controlled trial
Authors' conclusion
The addition of empagliflozin, pioglitazone, or glimepiride to metformin and DPP-4 inhibitors significantly improved glycaemic control in patients with T2D. The selection of a third agent should be individualized based on the patient characteristics.
Study context
- Population
- Patients with T2D inadequately controlled on metformin (≥1000 mg) and a DPP-4i; mean age 58.5 ± 10.0 years, HbA1c 7.8 ± 0.7%, diabetes duration 8.1 ± 5.6 years
- Participants
- 61 / 58 / 57
- Comparison
- Empagliflozin vs pioglitazone vs glimepiride as third-line agents added to metformin and DPP-4i
- Empagliflozinn = 61
- Pioglitazonen = 58
- Glimepiriden = 57
- Primary endpoint
- HbA1c change
- Follow-up
- 24 weeks
Methodological detailsmulticentre, prospective, open-label, parallel-group, phase 4
- Multicentre
- Prospective
- Open-label
- Parallel-group
- Phase 4
Primary result
As reported in the abstract
Empagliflozin
−0.78
± 0.09
Pioglitazone
−0.89
± 0.09
Glimepiride
−0.93
± 0.12
Further findings
HbA1c < 7.0%
| Outcome | Empagliflozin | Pioglitazone | Glimepiride |
|---|---|---|---|
| Weight change | −1.73 ± 3.14 kg | 1.11 ± 3.97 kg | 1.11 ± 4.07 kg |
HbA1c < 7.0%
- Proportions similar across the three regimens
Weight change
- Significant weight loss with empagliflozin; weight gain with pioglitazone and glimepiride
Safety
| Outcome | Empagliflozin | Pioglitazone | Glimepiride |
|---|---|---|---|
| Hypoglycaemic episodes | 0 events | 0 events | 6.56% |
Original publication
Efficacy and safety of pioglitazone, empagliflozin and glimepiride as third‐line agents in patients with type 2 diabetes inadequately controlled with metformin and DPP ‐4 inhibitors: A multicentre, phase 4 randomized controlled trial. Diabetes Obes Metab. Published 14 August 2025. doi:10.
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