CTRI/2021/09/036132已完成3 期
â??A Phase III, Prospective, Randomized, Double Blind, Active-Controlled, Comparative, Parallel Group, Multicentric Clinical Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Dapagliflozin plus Vildagliptin Sustained Release Tablets 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
- 270
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 >= 8.0% to <= 11.0%.
- •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. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •5. 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) > 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, 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.
- •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.
- •26. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
- •27. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening.
- •28. Patients with a history of substance abuse
研究者
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