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

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

Official Title
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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.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: MADALENA ASSOCIATION
* Drug: METFORMIN
* Drug: EMPAGLIFLOZIN + LINAGLIPTIN
* Other: MADALENA ASSOCIATION PLACEBO
* Other: METFORMIN PLACEBO
* Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MADALENA<br>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<br>* Madalena association coated tablet.<br>Other: METFORMIN PLACEBO<br>* Metformin placebo tablet.<br>Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO<br>* Empagliflozin + linagliptin placebo tablet.<br>|
| Active Comparator: Metformin + empagliflozin + linagliptin<br>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<br>* Metformin 1000 mg extended-release tablet.<br>Drug: EMPAGLIFLOZIN + LINAGLIPTIN<br>* Empagliflozin 10 mg + linagliptin 5 mg coated tablet.<br>Other: MADALENA ASSOCIATION PLACEBO<br>* Madalena association placebo tablet.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus