Actively Recruiting
Phase III Study to Test the Safety and Effectiveness of Piemonte Association Compared to Empagliflozin and Pioglitazone for Treating Type II Diabetes
Led by EMS · Updated on 2025-12-08
480
Participants Needed
1
Research Sites
61 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of the Piemonte association in treating type 2 diabetes mellitus. This phase III, randomized, double-blind clinical trial aims to compare Piemonte with empagliflozin and pioglitazone. The study includes adult participants who have not achieved their HbA1c targets despite stable doses of diet, exercise, and prior therapies. Participants will be assigned to one of three groups in a triple-dummy design. Each participant takes three tablets daily one active drug and two matching placebos. The groups include Piemonte association, empagliflozin 25 mg, or pioglitazone 30 mg. This approach ensures blinding while assessing the effects of each treatment. During the 120-day treatment period, researchers will monitor the primary outcome of glycated hemoglobin levels. Secondary measures include monitoring adverse events over 150 days. Participants will be evaluated regularly to assess safety and treatment effects. The total involvement spans several months, ensuring thorough assessment of outcomes and safety.
CONDITIONS
Brief Title
Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
Research Team
A
Arthur M Kummer, MD, PhD
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