CTRI/2024/03/063774尚未招募3 期
Assessment of Clinical Efficacy and Safety of Lobeglitazone Vs. Pioglitazone in T2DM Patients- A Prospective Open Label Randomized Controlled Trial.
Balamurugan M1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年3月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Fasting Blood Glucose (FBG)
研究概览
简要总结
Assessment of efficacy and safety of Lobeglitazone vs. pioglitazone in Type 2 diabetes mellitus patient duration of 3 months. The primary outcome of FPBG, PPBG, and HbA1c and the secondary outcome of the Lipid profile will be measured. The Trial will be conducted in a Hospital setup. Additionally, the patients will be monitored for any suspected Adverse drug reaction(ADR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to give informed consent form.
- •Patient with Body mass index 18.5 to 25.
排除标准
- •Patients with other complications like cardiac, renal, gastrointestinal, and hematological disorders.
- •Patients has undergone major surgery.
- •A patient who has known or suspected hypersensitivity to the study drugs.
- •Patients with pregnancy and lactation.
结局指标
主要结局
Fasting Blood Glucose (FBG)
时间窗: 1 month Interval
Post Prandial Blood Glucose(PPBG)
时间窗: 1 month Interval
HbA1C
时间窗: 1 month Interval
次要结局
- Lipid Profile(3 months interval)
研究者
Mrs S Sarumathy
SRM Institute of Science and Technology
研究点 (1)
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