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

EMS

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04670666

EMS1419 - MADALENA

Details and patient eligibility

About

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

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups

MADALENA

Experimental group

Description:

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.

Treatment:

Drug: MADALENA ASSOCIATION

Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO

Other: METFORMIN PLACEBO

Metformin + empagliflozin + linagliptin

Active Comparator group

Description:

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.

Treatment:

Other: MADALENA ASSOCIATION PLACEBO

Drug: EMPAGLIFLOZIN + LINAGLIPTIN

Drug: METFORMIN