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.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change from baseline in glycated hemoglobin (HbA1c) levels.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MADALENA
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.
干预措施: MADALENA ASSOCIATION (Drug)
MADALENA
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.
干预措施: METFORMIN PLACEBO (Other)
MADALENA
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.
干预措施: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO (Other)
Metformin + 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.
干预措施: METFORMIN (Drug)
Metformin + 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.
干预措施: EMPAGLIFLOZIN + LINAGLIPTIN (Drug)
Metformin + 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.
干预措施: MADALENA ASSOCIATION PLACEBO (Other)
结局指标
主要结局
Change from baseline in glycated hemoglobin (HbA1c) levels.
时间窗: 120 days
次要结局
- Incidence and severity of adverse events recorded during the study.(150 days)