Empagliflozin: Phase 3 T2DM Trial with Metformin Reaches Primary Completion

A Phase 3 clinical trial investigating empagliflozin in combination with metformin for Type 2 Diabetes (T2DM) reached its primary completion on 2026-04-16. The study, which enrolled 606 participants, evaluated the efficacy and safety of adding pioglitazone combination therapy to this background.

Background

The trial focused on patients with Type 2 Diabetes (T2DM) who had insufficient glycemic control despite existing combination therapy with empagliflozin and metformin. Empagliflozin (Jardiance) is an SGLT2 inhibitor, commonly used for T2DM, often in combination with other agents like metformin. This study specifically explored the addition of a pioglitazone combination therapy (CT-L03) to this established regimen, aiming to improve glycemic control further.

Trial design

The Phase 3 study (NCT06571591) enrolled 606 participants with Type 2 Diabetes (T2DM). The trial's objective was to assess the efficacy and safety of CT-L03 in patients whose glycemic control was insufficient with metformin and empagliflozin combination therapy. The interventions included different groups receiving CT-L03 group 1, CT-L03 group 2, or placebo, all on a background of empagliflozin and metformin.

What this means

The primary completion of this Phase 3 trial indicates that data collection for the study's primary endpoint has concluded. While specific efficacy and safety results are not yet available, this milestone signifies progress towards understanding the potential role of adding pioglitazone combination therapy to an empagliflozin and metformin regimen for patients with Type 2 Diabetes who require further glycemic control. Clinicians and researchers will await the full results to assess the clinical implications of these findings.

Source

Information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for the study NCT06571591, titled "Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin", was posted on 2026-04-16 on clinicaltrials.gov.