Efficacy and safety of lobeglitazone added to metformin and sitagliptin combination therapy in patients with type 2 diabetes: A 52‐week, multicentre, randomized, placebo‐controlled, phase III clinical trial
Primary result · Change in HbA1cResult — go to the resultBetween-group difference in adjusted mean change −1.03 %Authors' conclusion
The addition of lobeglitazone in patients with type 2 diabetes inadequately controlled with metformin and sitagliptin is a beneficial therapeutic option, not only providing effective glycaemic control but also improving insulin function such as sensitivity and enhancing certain lipid parameters.
Study context
- Population
- Korean patients with T2D and HbA1c 7.0%–10.0% despite metformin (≥1000 mg/day) and sitagliptin (100 mg/day)
- Participants
- 231 patients
- Comparison
- Lobeglitazone vs placebo added to metformin and sitagliptin
- Primary endpoint
- Change in HbA1c
- Follow-up
- 24 weeks
Methodological detailsmulticentre, double-blind, placebo-controlled, phase 3, 24-week randomised phase then 28-week open-label phase
- Multicentre
- Double-blind
- Placebo-controlled
- Phase 3
- 24-week randomised phase then 28-week open-label phase
Primary result
As reported in the abstract
week 24
Between-group difference in adjusted mean change
−1.03 %
P < 0.0001
Change by group
Lobeglitazone
−1.00
± 0.09 · %
Placebo
0.02
± 0.09 · %
Secondary outcomes
Fasting plasma glucose (FPG), homeostatic model assessment for insulin resistance (HOMA-IR), HOMA-β, QUICKI · week 24
- Lobeglitazone significantly reduced FPG vs placebo and improved HOMA-IR, HOMA-β and QUICKI
Lipid profile
- Lipid parameters improved with lobeglitazone
Safety
- Adverse events were similar in both arms
Original publication
Efficacy and safety of lobeglitazone added to metformin and sitagliptin combination therapy in patients with type 2 diabetes: A 52‐week, multicentre, randomized, placebo‐controlled, phase III clinical trial. Diabetes Obes Metab. Published 29 July 2025. doi:10.
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