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
USV Pvt Ltd10 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2022年1月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 10
- 主要终点
- Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study
研究概览
简要总结
It is a Phase III, Prospective, Randomized, Open Label, Active Controlled, Parallel Group, Multicenter Clinical Study.
Study comprises of 3 Arms .
For this study, test product will be FDC of Dapagliflozin 5mg + Vildagliptin 50 mg and Metformin 500 mg tablets of USV Pvt. Ltd., administered in morning and evening (BID).
Reference products will be • Reference 1 - Concomitant administration of Forxiga® Tablet containing Dapagliflozin (5mg) of AstraZeneca + Glycomet® Tablet containing Metformin (500mg) of USV Pvt. Ltd
• Reference 2 – FDC GalvusMet® Tablet containing Vildagliptin (50mg) + Metformin (500mg) of Novartis India Ltd (BID).
Total duration of the study is 12 weeks and there will be total 5 Visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
- •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.
- •Patients with no abnormality on 12-lead ECG at screening / baseline visit.
- •Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with the protocol requirements.
排除标准
- •Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
- •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
- •Patients with a history of metabolic acidosis or diabetic ketoacidosis.
- •Patients with the Body Mass Index (BMI) ≥ 45.0 kg/m2 at screening
- •Patients with Fasting Plasma Glucose (FPG) > 240 mg/dL at screening or randomization
- •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.
- •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.
- •Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 or DPP4 inhibitors
- •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
- •Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
- •Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
- •Patients with known case of infection with hepatitis B, hepatitis C or HIV.
- •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.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •Suspected inability or unwillingness to comply with the study procedures 16.
结局指标
主要结局
Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study
时间窗: SCREENING / BASELINE VISIT [V1](Day -7) Randomization visit [V2] (Day1) Follow up visit [V3] Week 2 / Day 14(±2) Follow up visit [V4] Week 6 / Day 42(±2) FINAL VISIT [V5] | Week 12/Day 84 (±2)
visit (12 Weeks)
时间窗: SCREENING / BASELINE VISIT [V1](Day -7) Randomization visit [V2] (Day1) Follow up visit [V3] Week 2 / Day 14(±2) Follow up visit [V4] Week 6 / Day 42(±2) FINAL VISIT [V5] | Week 12/Day 84 (±2)
次要结局
- • Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit((12 Weeks).)
研究者
研究点 (10)
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