CTRI/2021/11/038050已完成3 期
â??A Multicentric, Randomized, Prospective, Double Blind, Parallel Group, Active Controlled, Comparative and Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Dapagliflozin 5 mg plus Teneligliptin 20 mg Tablets and FDC of Dapagliflozin 10 mg plus Teneligliptin 20 mg Tablets Versus Dapagliflozin Tablets 10 mg and Teneligliptin Tablets 20 mg in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy.â??
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 293
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
- •1. Male or Female Patients aged between 18 to 65 years (both inclusive) with diagnosis of Type 2 diabetes mellitus.
- •2. Patients who have received stable dose of Metformin >= 1500 mg/day as monotherapy for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of >= 7.5% to <= 10.0%.
- •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 a history of bariatric surgery or lap-band procedure within 12 months prior to screening.
- •4. Patients with Fasting Plasma Glucose (FPG) > 220 mg/dL at screening (If FPG is > 220 mg/dL at screening, FPG will be repeated within 1 week. If repeat FPG is > 220 mg/dL, patient will be excluded from the study).
- •5. Patients with the Body Mass Index (BMI) >= 45.0 kg/m2 at screening.
- •6. 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.
- •7. 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.
- •8. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
- •9. 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.
- •10. Patients with uncontrolled hypertension with sitting systolic BP >= 160 mmHg and/or diastolic BP >= 100 mmHg at screening.
- •11. 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 patientâ??s participation in the study. For male patients with mean QTcB >= 450 msec or female patients 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, patient will be excluded from the study.
- •12. Patients with history of hereditary QT prolongation syndrome or patients having history of Torsades de pointes.
- •13. Patients who are accepting treatments of arrhythmias.
- •14. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
- •15. Patients with known history of acute pancreatitis.
- •16. Patients with intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other DPP4 inhibitors or SGLT-2 inhibitors.
- •17. Patients with a history of severe hepatobiliary disease or hepatotoxicity with any medication.
- •18. Patients with known case of congenital renal glucosuria, history of unstable or rapidly progressing renal disease.
- •19. Patients with a history of urinary tract infections including urosepsis and pyelonephritis.
- •20. Patients with a history of genital mycotic infections.
- •21. Patients with known immunocompromised status.
- •22. Patients receiving treatment with systemic corticosteroids.
- •23. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
- •24. 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).
- •25. Patients with history of any malignancy.
研究者
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