Phase 4 trial compares pioglitazone versus dapagliflozin add-on in type 2 diabetes

This phase 4 randomized controlled trial, conducted at multiple centers in the Republic of Korea, enrolled 133 participants with type 2 diabetes mellitus inadequately controlled by DPP-4 inhibitor and metformin therapy. The study aimed to assess non-inferiority of two treatment intensification strategies. Participants were randomized to receive either pioglitazone 15 mg (with potential titration to 30 mg at Week 12 if HbA1c was ≥7.5%) or dapagliflozin 10 mg, both in combination with fixed-dose alogliptin 25 mg and background metformin therapy of at least 500 mg. The primary outcome was the mean change from baseline in HbA1c at Week 26. The overall time to participate in the study was up to 36 weeks.

No efficacy results for the primary or any secondary outcomes are reported in the provided trial record. The mean change in HbA1c, effect sizes, absolute numbers, and statistical significance (p-values or confidence intervals) are all listed as 'not reported'. Similarly, no safety or tolerability data are provided, including rates of adverse events, serious adverse events, or treatment discontinuations.

Key limitations stem from the nature of the source, which is a clinical trial registration record rather than a published results paper. The absence of reported outcomes prevents any assessment of efficacy, safety, or whether the non-inferiority objective was met. The study was funded by Celltrion Pharm, Inc., the lead sponsor. For clinical practice, this record indicates an area of active investigation but provides no evidence to guide treatment decisions between these two add-on strategies. Clinicians must await the publication of peer-reviewed results to understand the comparative effectiveness and safety profile.