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

Официальное название

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.

Обзор

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

Вмешательства

• Препарат MADALENA ASSOCIATION
  Madalena association coated tablet.
• Препарат METFORMIN
  Metformin 1000 mg extended-release tablet.
• Препарат EMPAGLIFLOZIN + LINAGLIPTIN
  Empagliflozin 10 mg + linagliptin 5 mg coated tablet.
• Другое MADALENA ASSOCIATION PLACEBO
  Madalena association placebo tablet.
• Другое METFORMIN PLACEBO
  Metformin placebo tablet.
• Другое EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO
  Empagliflozin + linagliptin placebo tablet.

Первичные конечные точки

• Change from baseline in glycated hemoglobin (HbA1c) levels. [Срок оценки: 120 days]

Вторичные конечные точки (1)

• Incidence and severity of adverse events recorded during the study. [Срок оценки: 150 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• EMS — Hortolândia

Идентификаторы

NCT: NCT04670666 · EMS1419 - MADALENA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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