National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Piemonte 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
- 480
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Piemonte 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 85 Years（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 consent form;
- •Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise, and previous therapies at stable doses within 3 months.
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of 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 pregnacy and lactating participants;
- •Known hypersensitivity to any of the formula compounds;
- •Type 1 diabetes.
研究组 & 干预措施
Piemonte association
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:
1 tablet Piemonte, oral;
1 placebo tablet of empagliflozin, oral;
1 placebo tablet of piglitazone, oral.
干预措施: PIEMONTE (Drug)
Piemonte association
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:
1 tablet Piemonte, oral;
1 placebo tablet of empagliflozin, oral;
1 placebo tablet of piglitazone, oral.
干预措施: PLACEBO EMPAGLIFLOZIN (Other)
Piemonte association
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:
1 tablet Piemonte, oral;
1 placebo tablet of empagliflozin, oral;
1 placebo tablet of piglitazone, oral.
干预措施: PLACEBO PIOGLITAZONE (Other)
Empagliflozin
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:
1 placebo tablet of Piemonte, oral;
1 tablet of empagliflozin, oral;
1 placebo tablet of piglitazone, oral.
干预措施: PIEMONTE PLACEBO (Other)
Empagliflozin
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:
1 placebo tablet of Piemonte, oral;
1 tablet of empagliflozin, oral;
1 placebo tablet of piglitazone, oral.
干预措施: EMPAGLIFLOZIN (Drug)
Empagliflozin
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:
1 placebo tablet of Piemonte, oral;
1 tablet of empagliflozin, oral;
1 placebo tablet of piglitazone, oral.
干预措施: PLACEBO PIOGLITAZONE (Other)
Pioglitazone
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:
1 placebo tablet of Piemonte, oral;
1 placebo tablet of empagliflozin, oral;
1 tablet of piglitazone, oral.
干预措施: PIEMONTE PLACEBO (Other)
Pioglitazone
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:
1 placebo tablet of Piemonte, oral;
1 placebo tablet of empagliflozin, oral;
1 tablet of piglitazone, oral.
干预措施: PLACEBO EMPAGLIFLOZIN (Other)
Pioglitazone
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows:
1 placebo tablet of Piemonte, oral;
1 placebo tablet of empagliflozin, oral;
1 tablet of piglitazone, oral.
干预措施: PIOGLITAZONE (Drug)
结局指标
主要结局
Glycated hemoglobin
时间窗: 120 days
Change from baseline in glycated hemoglobin
次要结局
- Adverse events(150 days)