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

Phase 3

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MADALENA ASSOCIATION; Drug: METFORMIN; Other: METFORMIN PLACEBO; Drug: EMPAGLIFLOZIN + LINAGLIPTIN; Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO; Other: MADALENA ASSOCIATION PLACEBO

• Registration Number: NCT04670666
• Lead Sponsor: EMS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Study Start: 2024-05
• Primary Completion: 2025-02
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MADALENA	MADALENA ASSOCIATION	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.
MADALENA	METFORMIN PLACEBO	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.
MADALENA	EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO	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.
Metformin + empagliflozin + linagliptin	METFORMIN	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.
Metformin + empagliflozin + linagliptin	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.
Metformin + empagliflozin + linagliptin	MADALENA ASSOCIATION PLACEBO	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in glycated hemoglobin (HbA1c) levels.	120 days

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events recorded during the study.	150 days