Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
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
EMS
480 participants
Oct 8, 2024
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus
Eligibility
Inclusion Criteria2
- 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 Criteria6
- 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.
Interventions
Piemonte association 1 coated tablet once a day
Placebo of Piemonte association 1 coated tablet once a day
Empagliflozin 25 mg 1 coated tablet once a day
Placebo of empagliflozin 25 mg 1 coated tablet once a day
Pioglitazone 30 mg 1 tablet once a day
Placebo of pioglitazone 30 mg 1 tablet once a day
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05028140