National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus

EMS1020 - PIEMONTE

The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus

2024-03-01

2026-03-01

2026-09-01

Not yet recruiting

Early phase I

480

Inclusion Criteria: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form; * Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise, and previous therapies at stable doses within 3 months. Exclusion Criteria: * Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants; * History of alcohol abuse or illicit drug use; * Participation in a clinical trial in the year prior to this study; * Pregnancy or risk of pregnacy and lactating participants; * Known hypersensitivity to any of the formula compounds; * Type 1 diabetes.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 480, 'type': 'ESTIMATED'}}

2024-02-16