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
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 490
- 试验地点
- 17
- 主要终点
- Mean Change in HbA1c from base line to day 84, Week 12.
研究概览
简要总结
This is 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.
The efficacy of Imeglimin 500 mg and 1000 mg tablet is tested and proven in the treatment improve glycemic control in patients with type-II diabetes mellitus as per available clinical data. Therefore, we are conducting this phase IV clinical trial to determine the safety and efficacy of Imeglimin 500 mg 1000 mg tablet in Indian subjects. Eligible patients will be randomized to either Arm 1- Imeglimin 500 mg (two tablets in the morning & two tablets in the evening) or Arm 2- Imeglimin 1000 mg tablet (one tablet in the morning & one tablet in the evening). It would be a multi-centric clinical trial. We will adopt the consecutive enrollment, wherein each patient will be screened and enrolled into the study if found eligible.
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
- •Subject who agrees for giving informed consent and provide signed and dated written IEC or IRB approved Informed Consent Form prior to initiation of any study procedures.
- •Male and Female subjects of group age Greater than or equal to 18 to Less than or equal to 65 years.
- •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 Greater than or equal to 7.5 to Less than or equal to 8.5 Percentage.
- •Type 2 diabetes of fasting glucose Greater than or equal to 126 mg per dL.
- •Women of childbearing potential must be using an acceptable method of contraception to avoid pregnancy throughout the study.
排除标准
- •Subjects who are not able to or not willing to sign an IRB or 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 or lactating mothers.
- •Fasting plasma glucose Greater than 200 mg per dL.
- •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 from base line to day 84, Week 12.
时间窗: Baseline and Week 12 (Day 84).
次要结局
- Mean change in fast plasma glucose from baseline to EOT(Baseline, Week 2 (Day 14), Week 6 (Day 42), Week 12 (Day 84) and Week 16 (Day 112).)
- The number of adverse events will be documented to evaluate the safety profile of study drugs from baseline to EOT (Day 112, Week 16).(Throughout the Study.)
- Safety assessments such as Serum Lipid Profile (Triglycerides, HDL and LDL), LFT and RFT (BUN, Serum Creatinine and eGFR) from base line and EOT (Day 112, Week 16).(Baseline and Week 16 (Day 112).)
- Mean change in 2hrs post prandial plasma glucose (2hrs PPG) from baseline to EOT.(Baseline, Week 2 (Day 14), Week 6 (Day 42), Week 12 (Day 84) and Week 16 (Day 112).)
- Proportion of patients achieving a Therapeutics glycemic response defined as HbA1C 7 percent at the day 84, Week 12.(Week 12 (Day 84).)
研究者
Dr Aditya Kaushik
Synokem Pharmaceuticals Ltd.