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.

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

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: MADALENA ASSOCIATION; Other: METFORMIN PLACEBO; Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO; Drug: METFORMIN; Drug: EMPAGLIFLOZIN + LINAGLIPTIN; Other: MADALENA ASSOCIATION PLACEBO

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Monalisa FB Oliveira, MD; Phone Number: +551938879851; Email: pesquisa.clinica@ncfarma.com.br

Study Locations

• Brazil
  • São Paulo
    • Hortolândia, São Paulo, Brazil
      • Recruiting
      • EMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Current medical history of cancer and/ or cancer treatment in the last 5 years;
• Medical history of metabolic acidosis and/or using drugs that may cause lactic acidosis;
• Medical history of blood dyscrasia or any other hemolytic disorders;
• Participants using sulfonylureas and/or insulin therapy;
• Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MADALENA; 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; Madalena association coated tablet.; Other: METFORMIN PLACEBO; Metformin placebo tablet.; Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO; Empagliflozin + linagliptin placebo tablet.
Active Comparator: Metformin + empagliflozin + linagliptin; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in glycated hemoglobin (HbA1c) levels.	120 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events recorded during the study.	150 days

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Purines; Biguanides; Guanidines; Amidines; Quinazolines; Linagliptin; Metformin; empagliflozin
• Other Study ID Numbers: EMS1419 - MADALENA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No