A Multi-centric, Open label, Randomized, Non-Comparative, Two-Arm, Phase IV clinical trial to evaluate the safety and efficacy of Imeglimin 500 mg and 1000 mg tablets in the treatment of patients diagnosed with type-II diabetes mellitus in adequate control of diet and exercise alone.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 490
- 试验地点
- 5
- 主要终点
- Mean Change in HbA1c
研究概览
简要总结
A Multi-centric, Open label, Randomized, Non-Comparative, Two-Arm, Phase IV clinical trial to evaluate the safety and efficacy of Imeglimin 500 mg and 1000 mg tablets in the treatment of patients diagnosed with type-II diabetes mellitus in adequate control of diet and exercise alone.
Primary Objective
To evaluate the safety of Imeglimin 500 mg and 1000 mg tablets in the treatment of patients diagnosed with type-II diabetes mellitus in adequate control of diet and exercise alone.
Secondary Objective
To evaluate the efficacy of Imeglimin 500 mg and 1000 mg tablets in the treatment of patients diagnosed with type-II diabetes mellitus in adequate control of diet and exercise alone.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures.
- •2.Male and Female subjects of group age ≥18 to ≤ 65 years.
- •3.Treatment naïve patients with inadequately controlled with diet and exercise therapy alone for the at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of ≥7.5 to ≤ 8.5 %.
- •4.Type 2 diabetes (fasting glucose ≥126 mg/dl).
- •5.Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study.
- •WOCBP must have a negative urine pregnancy test at screening/ base line.
排除标准
- •Subjects who are not able to or not willing to sign an IRB/IEC approved consent form.
- •Subject with positive pregnancy test as confirmed by urine dipstick test.
- •Subject who is planning to become pregnant within the study duration/lactating mothers.
- •Fasting plasma glucose > 200 mg/dl (>15 mmol/L).
- •Type 1 diabetes and Evidence of serious diabetic complications.
- •Evidence of serious cardiovascular complications.
- •Laboratory value abnormalities as defined by the protocol.
结局指标
主要结局
Mean Change in HbA1c
时间窗: from base line to Day 84 week 12.
次要结局
- Mean Change in fasting plasma glucose from baseline to EOT (Day 112, week16).
- Mean Change in 2-hr post prandial plasma glucose (2-hr PPG)
- Proportion of patients achieving a therapeutic glycemic response, defined as(HBA1C 7%)
研究者
Mukesh Kumar
RAHE Life Science