Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
Recruiting · NCT05028140 · Interventional (participants receive a specific treatment) · Lead sponsor: EMS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- EMS - Hortolândia, São Paulo, Brazil