NCT01433406已完成3 期
Long-term Study of TAK-875
Takeda0 个研究点目标入组 1,222 人开始时间: 2011年10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
- 已完成
- 发起方
- 入组人数
- 1,222
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with TAK-875 in diabetic patients.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is an outpatient.
- •The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
排除标准
- •The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- •The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.
研究组 & 干预措施
TAK-875 25 mg
Experimental
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
干预措施: TAK-875 (Drug)
TAK-875 50 mg
Experimental
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
干预措施: TAK-875 (Drug)
结局指标
主要结局
Adverse events
时间窗: From Baseline to Week 53
Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
Long-term Efficacy and Safety Study of TAK-085 in Participants With HypertriglyceridemiaHypertriglyceridemiaNCT01350999Takeda503
进行中（未招募）
3 期
A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)NCT06076642Takeda53
终止
3 期
Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01481116Takeda2,454
已完成
3 期
Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive EsophagitisErosive EsophagitisNCT01452776Takeda305
已完成
2 期
Efficacy and Safety of TAK-875 in Combination With Sitagliptin in Participants With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT01414920Takeda368