NCT03766750撤回3 期
Randomized, Double-blind, Multicenter, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus
EMS0 个研究点开始时间: 2021年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Lima association in the control 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
- •Participants of both sexes, aged 18 years or more;
- •Participants presenting the diagnosis of type II diabetes mellitus, which have already received previous dietary and physical exercise guidance, who are not receiving any antidiabetic treatment, defined as never taking any antidiabetic medication, or in antidiabetic therapy after being subjected to a washout period;
- •Treatment-naive participants with HbA1c between 7.5% and 10.5% and pretreated patients with HbA1c between 7,5% and 9,5% at the screening visit;
- •Patients with HbA1c between 7.5% and 10.5% at the randomization visit;
- •Participants with BMI (body mass index) > 19 Kg/m2 and ≤ 45 Kg/m
- •Signed consent.
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 clinical trial in the year prior to this study.
- •Fasting glycemia above 300 mg/dL;
- •Risk factors for severe volume depletion;
- •Diuretic use less than 60 days, except for spironolactone;
- •History of diabetic ketoacidosis;
- •Medical history of acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to informed consent;
- •Impaired hepatic function;
- •Impaired renal function and end stage renal disease;
- •Bariatric surgery in the last two years and/ or other gastrointestinal surgeries;
- •Current medical history of cancer and/ or cancer treatment in the last 5 years;
- •Medical history of blood dyscrasia or any other hemolytic disorders;
- •Medical history of pancreatitis and chronic pancreatitis;
- •Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months;
- •Current and prolonged treatment for more than 15 days with systemic steroids at the moment of informed consent;
- •Any other uncontrolled endocrine disorder, except type 2 diabetes mellitus;
- •History hypersensitivity to the active ingredients used in the study;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Systemic disease that is not controlled and can put the participant at risk;
研究组 & 干预措施
LIMA
Experimental
干预措施: LIMA association (Drug)
Tradjenta®
Active Comparator
干预措施: Tradjenta (Drug)
Forxiga®
Active Comparator
干预措施: Forxiga (Drug)
结局指标
主要结局
Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
时间窗: 120 days
次要结局
- Incidence and severity of adverse events recorded during the study.(210 days)
研究者
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