CTRI/2023/06/053621已完成4 期
An Open Label, Prospective, Randomized, Non-comparative, Multicentric, Phase IV Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Imeglimin Hydrochloride Tablets 500 mg in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise Alone. ?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male or Female Patients aged between 18 to 65 years (both inclusive) with diagnosis of Type 2 diabetes mellitus.
- •2. Treatment naïve patients with inadequately controlled with diet and exercise therapy alone for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of > 7.0% to = 8.5%.
- •3. 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 / baseline visit.
- •4. Patients with no abnormality on 12-lead ECG at screening / baseline visit.
- •5. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •6. Patients willing to comply with the protocol requirements.
排除标准
- •1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
- •2. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
- •3. Patients with fasting plasma glucose (FPG) > 200 mg/dL at screening.
- •4. Patients with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening.
- •5. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 2X the UNL) at screening.
- •6. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
- •7. Patients with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
- •8. Patients with uncontrolled hypertension with sitting systolic BP = 160 mmHg and/or diastolic BP = 100 mmHg at screening.
- •9. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
- •10. Patients with known hypersensitivity to any of the ingredients of study medication.
- •11. Patients receiving treatment with systemic corticosteroids.
- •12. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
- •13. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
- •14. Patients with history of any malignancy.
- •15. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
- •16. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening.
- •17. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
- •18. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •19. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
- •20. Suspected inability or unwillingness to comply with the study procedures.
- •21. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
研究者
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