A Phase 3 clinical trial evaluating the efficacy and safety of Empagliflozin (as part of the "Berlim 25/10 association") for the treatment of Type 2 Diabetes Mellitus and Dyslipidemia reached its primary completion on 2025-04-30. This milestone indicates that data collection for the primary endpoint has concluded.
Background
Empagliflozin is being investigated in this trial as part of a "Berlim 25/10 association" alongside rosuvastatin calcium. The study aims to address the concurrent management of Type 2 Diabetes Mellitus and Dyslipidemia, two common metabolic conditions that often coexist and contribute to significant health risks.
Trial design
The trial, identified as NCT04603508, is a Phase 3 study with an enrollment of 240 participants. It investigates the efficacy and safety of the "Berlim 25/10 association" in patients with Type 2 Diabetes Mellitus and Dyslipidemia. Interventions listed in the study include the "Berlim 25/10 association," empagliflozin, and rosuvastatin calcium.
What this means
The primary completion of this Phase 3 trial signifies that all data required for the evaluation of the primary endpoint has been collected. Researchers will now proceed with data analysis to determine the efficacy and safety profile of the "Berlim 25/10 association" for patients with Type 2 Diabetes Mellitus and Dyslipidemia. The findings from this study will be crucial for understanding the potential role of this combination therapy in clinical practice.
Source
Information regarding the primary completion of this clinical trial was obtained from the public database ClinicalTrials.gov. The record for study NCT04603508, titled "Efficacy and Safety of Berlim 25/10 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia," was updated with the primary completion date of 2025-04-30 on clinicaltrials.gov.