RecruitingPhase 3NCT04670666

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

National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus.


Sponsor

EMS

Enrollment

270 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination medication approach (called the 'Madalena Association') for people with Type 2 diabetes whose blood sugar is not well controlled despite already being on two diabetes medications. Researchers want to see if this new combination is safe and effective at lowering blood sugar levels. **You may be eligible if you:** - Are 18 years of age or older - Have been diagnosed with Type 2 diabetes - Have blood sugar (HbA1c) levels between 7.5% and 10.5% despite being on two blood sugar-lowering medications for at least 3 months - Have a BMI between 19 and 45 kg/m² **You may NOT be eligible if you:** - Have other medical conditions or lab results that the investigator thinks may interfere with the study - Have Type 1 diabetes or other forms of diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMADALENA ASSOCIATION

Madalena association coated tablet.

DRUGMETFORMIN

Metformin 1000 mg extended-release tablet.

DRUGEMPAGLIFLOZIN + LINAGLIPTIN

Empagliflozin 10 mg + linagliptin 5 mg coated tablet.

OTHERMADALENA ASSOCIATION PLACEBO

Madalena association placebo tablet.

OTHERMETFORMIN PLACEBO

Metformin placebo tablet.

OTHEREMPAGLIFLOZIN + LINAGLIPTIN PLACEBO

Empagliflozin + linagliptin placebo tablet.


Locations(1)

EMS

Hortolândia, São Paulo, Brazil

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NCT04670666


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