CTRI/2022/07/044440已完成3 期
A Phase III, Prospective, Randomized, Open Label, Active Controlled, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination of Dapagliflozin + Vildagliptin and Metformin Tablets (5/50/500)mg USV Private Limited, as compared to Reference Products, concomitant administration of Forxiga® (Dapagliflozin Tablets 5mg) + GlycoMet® Metformin 500 mg and Fixed dose combination of Galvus-Met® (Vildagliptin 50mgMetformin HCl 500mg) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on earlier metformin dual therapy
SV Pvt Ltd0 个研究点目标入组 202 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
- 202
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 (both inclusive) years with diagnosis of
- •Type 2 diabetes mellitus at the time of informed consent.
- •2. Patients who are presently on Metformin dual therapy (i.e. a combination of Metformin
- •500mg with Vildagliptin 50 mg or Dapaglifloxin 5 mg BID, for at least 12 weeks prior
- •to screening and having HbA1c levels of >= 7.5 % to <= 10% at screening/baseline.
- •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. Subjects with symptomatic urinary tract infection or mycotic genital infection at
- •screening or history of a recent symptomatic infection within 4 weeks prior to screening
- •3. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
- •4. Patients with the Body Mass Index (BMI) >= 45.0 kg/m2 at screening
- •5. Patients with Fasting Plasma Glucose (FPG) > 240 mg/dL at screening or randomization
- •6. Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [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.
- •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. Intolerance, contraindication or potential allergy/hypersensitivity to any of the
- •ingredients of study medication or any other SGLT2 or DPP4 inhibitors
- •9. Subjects with symptomatic urinary tract infection or mycotic genital infection at
- •screening or history of a recent symptomatic infection within 4 weeks prior to screening
- •10. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL
- •for men; haemoglobin < 9 g/dL for women at screening.
- •11. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the
- •12. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
- •13. Patients with a history of substance abuse or dependence that in the opinion of the
- •Investigator is considered to interfere with the patientâ??s participation in the study.
- •14. Patients with concurrent participation in another clinical trial or any investigational
- •therapy within 90 days prior to signing informed consent.
- •15. Suspected inability or unwillingness to comply with the study procedures
- •16. 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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