Status:
RECRUITING
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Lead Sponsor:
EMS
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Impaired renal function and end-stage renal disease;
- Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent;
- Impaired hepatic function;
- Medical history of pancreatic diseases that may suggest insulin deficiency;
- Bariatric surgery in the last two years and/ or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;
- Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;
- Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent;
- Current medical history of cancer and/ or cancer treatment in the last 5 years;
- Medical history of metabolic acidosis and/or using drugs that may cause lactic acidosis;
- Medical history of blood dyscrasia or any other hemolytic disorders;
- Participants using sulfonylureas and/or insulin therapy;
- Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.
Key Trial Info
Start Date :
November 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04670666
Start Date
November 18 2024
End Date
June 1 2027
Last Update
December 8 2025
Active Locations (1)
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1
EMS
Hortolândia, São Paulo, Brazil