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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04670666
• Other study ID #: EMS1419 - MADALENA
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: EMS
• Contact: Monalisa FB Oliveira, MD
• Phone: +551938879851
• Email: pesquisa.clinica[@]ncfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MADALENA ASSOCIATION
Madalena association coated tablet.
• METFORMIN
Metformin 1000 mg extended-release tablet.
• EMPAGLIFLOZIN + LINAGLIPTIN
Empagliflozin 10 mg + linagliptin 5 mg coated tablet.

Other:
• MADALENA ASSOCIATION PLACEBO
Madalena association placebo tablet.
• METFORMIN PLACEBO
Metformin placebo tablet.
• EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO
Empagliflozin + linagliptin placebo tablet.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in glycated hemoglobin (HbA1c) levels.		120 days
Secondary	Incidence and severity of adverse events recorded during the study.		150 days