Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
ConditionType 2 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMS
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- MADALENA ASSOCIATION
- METFORMIN
- EMPAGLIFLOZIN + LINAGLIPTIN
- MADALENA ASSOCIATION PLACEBO
- METFORMIN PLACEBO
- EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO
Treatment groups
270 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov