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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

MADALENA ASSOCIATION
Drug
Madalena association coated tablet.
METFORMIN
Drug
Metformin 1000 mg extended-release tablet.
EMPAGLIFLOZIN + LINAGLIPTIN
Drug
Empagliflozin 10 mg + linagliptin 5 mg coated tablet.
MADALENA ASSOCIATION PLACEBO
Other intervention
Madalena association placebo tablet.
METFORMIN PLACEBO
Other intervention
Metformin placebo tablet.
EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO
Other intervention
Empagliflozin + linagliptin placebo tablet.

Treatment groups

270 Participants

are divided into 2 treatment groups

Group A: MADALENAExperimental treatment 3 interventions

Group B: Metformin + empagliflozin + linagliptinActive comparator 3 interventions

Trial outcomes

Primary outcomes

Change from baseline in glycated hemoglobin (HbA1c) levels.

Time frame

120 days

Secondary outcomes

Incidence and severity of adverse events recorded during the study.

Time frame

150 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMS

Lead sponsor

Source ClinicalTrials.gov

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