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

NCT04670666 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-12-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.

Conditions

Interventions

DRUG

MADALENA ASSOCIATION

Madalena association coated tablet.

DRUG

METFORMIN

Metformin 1000 mg extended-release tablet.

DRUG

EMPAGLIFLOZIN + LINAGLIPTIN

Empagliflozin 10 mg + linagliptin 5 mg coated tablet.

OTHER

MADALENA ASSOCIATION PLACEBO

Madalena association placebo tablet.

OTHER

METFORMIN PLACEBO

Metformin placebo tablet.

OTHER

EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO

Empagliflozin + linagliptin placebo tablet.

Sponsors & Collaborators

  • EMS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2026-07-31
Completion
2027-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04670666 on ClinicalTrials.gov