RecruitingType 2 Diabetes Mellitus
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.
Sponsor: EMS
You may qualify if…
- ✓ Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- ✓ Participants with 18 years of age or greater;
- ✓ Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and at least 3 months with two anti-hyperglycemic agents (dual therapy);
- ✓ HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose \> 100 mg/dL at the screening visit;
- ✓ BMI (body mass index) \> 19 Kg/m2 and ≤ 45 Kg/m2.
You may not qualify if…
- ✕ Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research 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 pregnancy and lactating patients;
- ✕ Known hypersensitivity to the formula components used during the clinical trial;
- ✕ Type 1 diabetes mellitus;
- ✕ Fasting blood glucose \> 300 mg/dL;
- ✕ Risk factors for volume depletion;
Source: ClinicalTrials.gov · NCT04670666 · last updated 2025-12-08