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Recruiting Phase 3

Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus

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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.

Condition
Type 2 Diabetes Mellitus
Tested
MADALENA ASSOCIATION, METFORMIN, EMPAGLIFLOZIN + LINAGLIPTIN, MADALENA ASSOCIATION PLACEBO, METFORMIN PLACEBO, EMPAGLIFL...
Sponsor
EMS

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 18 years
  • Study condition: Type 2 Diabetes Mellitus
  • 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 20

  • 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.

Where

1 site, 1 recruiting

EMS

Hortolândia, São Paulo, Brazil

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.