CTRI/2024/09/073221招募中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 and Pioglitazone Tablets 10mg/15mg of USV Private Limited., India as compared to Concomitant Administration of Reference Product Forxiga 10 mg (Dapagliflozin) of AstraZeneca Pharma India limited., along with Pioglit® 15 mg (Pioglitazone) tablets of Sun Pharma Laboratories India Ltd., in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on earlier metformin containing mono therapy
USV Pvt Ltd16 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年9月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 16
- 主要终点
- Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit (12 Weeks).
研究概览
简要总结
A PhaseIII, Prospective, Randomized, Open Label, ActiveControlled, Parallel Group,Multicenter Clinical Study
Test Product: Fixed Dose Combination ofDapagliflozin and pioglitazone Tablets 10mg/15mg of USV Private Limited., Indiaadministered in morning (OD).
ReferenceProducts: Concomitantadministration of Forxiga 10 mg (Dapagliflozin)tablets of AstraZeneca Pharma India limited and Pioglit® 15mg (Pioglitazone) tablets, of Sunpharma Laboratories Pharmaceuticals, administeredin morning (OD).
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
- •1.Male or Female Patients aged between 18 to 65 (both inclusive) years with diagnosis of Type 2 diabetes mellitus. 2.Patients who have ongoing mono therapy.
- •to be enrolled and continue them with dual therapy. i.e Patients with HbA1C level ≥ 7.5% to 10%.and who are presently on ≥1000 mg/day Metformin for at least 3 months prior to screening 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 study.
- •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 patient’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.
结局指标
主要结局
Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study 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
- â—Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (12 Weeks).(â—Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (12 Weeks).)
研究者
研究点 (16)
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