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

NCT04670666 | Recruiting Phase 3 DMC

• 1 other identifier: EMS1419 - MADALENA
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in glycated hemoglobin (HbA1c) levels.

  120 days

Secondary Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  150 days

Study Arms (2)

MADALENA

EXPERIMENTAL

The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Madalena association, oral; 1 tablet empagliflozin + linagliptin association placebo, oral; 1 tablet metformin placebo, oral.

Drug: MADALENA ASSOCIATION; Other: METFORMIN PLACEBO; Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO

Metformin + empagliflozin + linagliptin

ACTIVE COMPARATOR

The patient must take 3 tablets once a day, as follows: 1 tablet Madalena association placebo, oral; 1 tablet empagliflozin + linagliptin association, oral; 1 tablet metformin, oral.

Drug: METFORMIN; Drug: EMPAGLIFLOZIN + LINAGLIPTIN; Other: MADALENA ASSOCIATION PLACEBO

Interventions

MADALENA ASSOCIATION DRUG

Madalena association coated tablet.

MADALENA

METFORMIN DRUG

Metformin 1000 mg extended-release tablet.

Metformin + empagliflozin + linagliptin

EMPAGLIFLOZIN + LINAGLIPTIN DRUG

Empagliflozin 10 mg + linagliptin 5 mg coated tablet.

Metformin + empagliflozin + linagliptin

MADALENA ASSOCIATION PLACEBO OTHER

Madalena association placebo tablet.

Metformin + empagliflozin + linagliptin

METFORMIN PLACEBO OTHER

Metformin placebo tablet.

MADALENA

EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO OTHER

Empagliflozin + linagliptin placebo tablet.

MADALENA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

EMS

Hortolândia, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; empagliflozin; Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Central Study Contacts

Monalisa FB Oliveira, MD

CONTACT

+551938879851; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: November 18, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

BR (1)