CTRI/2020/04/024841已完成3 期
A randomised, double-blind, double-dummy, parallel-group, multicentre, active-controlled study to evaluate efficacy and safety of fixed dose combination of remogliflozin etabonate and teneligliptin in subjects with type-2 diabetes mellitus.
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 308 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 308
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female subjects >=18 and <= 65 years of age, diagnosed with T2DM.
- •Subjects who have received stable dose of metformin >=1500 mg/day as monotherapy for at least 10 weeks prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of >=8% to <=11%.
- •Subjects must be willing and able to provide written informed consent.
- •Willing and able to comply with all aspects of the protocol.
- •Must be willing to use a highly effective form of contraception (with pearl index < 1%) e.g. double barrier method, for the duration of the study. Methods like periodic abstinence, post ovulation procedures and withdrawal are not considered adequate. Oral contraceptive pills are not allowed due to potential of drug interaction with investigational product. If the subject is a female of childbearing potential, the result of a urine pregnancy test at screening must be negative. Each female will be considered to have childbearing potential unless surgically sterilized by hysterectomy or has been post-menopausal for at least 2 years.
排除标准
- •History of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus
- •History of metabolic acidosis or diabetic ketoacidosis
- •FPG >270 mg/dL at screening.
- •If FPG is >270 mg/dL at screening, FPG will be repeated within 1 week. If repeat FPG is >270 mg/dL, subject will be excluded from the study.
- •BMI >=45.0 kg/m2 at screening
- •Subjects with elevated thyroid stimulating hormone (TSH) level at screening with or without thyroid hormone replacement therapy
- •Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation or serum creatinine level of > 1.5 mg/dL for male subjects and > 1.4 mg/dL for female subjects, at screening
- •Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3X ULN or total serum bilirubin >2.0 mg/dL at screening
- •Congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
- •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.
- •10. Subjects with uncontrolled hypertension with sitting systolic BP >=160 mmHg and/or diastolic BP >= 100 mmHg at screening. Note: Subjects with SBP >= 160mmHg and < 180mmHg or a DBP >= 100 mmHg and < 110mmHg will be able to enter the run-in period, provided their hypertension treatment is adjusted as deemed appropriate by the investigator. These subjects cannot be randomized if they meet the blood pressure exclusion criterion of SBP >= 160 mmHg or DBP >= 100 mmHg measured at randomization visit.
- •Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for subjectâ??s participation in the study. For male subjects with mean QTcB >=450 msec or female subjects with mean QTcB >=470 msec, triplicate ECG will be performed. If mean QTcB is >=450 msec in males or mean QTcB is >=470 msec in females on triplicate ECG, subject will be excluded from the study.
- •Patients with history of hereditary QT prolongation syndrome or patients having history of Torsades de pointes.
- •Patients with history of abdominal surgery or intestinal obstruction.
- •Patients with history of acute pancreatitis.
- •History of anaemia or haemoglobinopathy and/or haemoglobin <10 g/dL ( <100 g/L) for men; haemoglobin <9 g/dL ( <90 g/L) for women at screening
- •Donation or transfusion of blood, plasma, or platelets within the past 3 months prior to enrolment
- •History of malignancy within the last 5 years prior to enrolment, excluding non-melanoma skin cancer (e.g. basal or squamous cell skin carcinoma) or treated carcinoma-in-situ of cervix
- •Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors or DPP4 inhibitors
- •Subjects with symptomatic diarrhoea or any other medical condition which the investigators may judge to be a risk for dehydration and hypovolemia
- •Subjects with symptomatic urinary tract infection or mycotic genital infection at s
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