CTRI/2024/02/062299尚未招募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 and 15mg of Eris Lifesciences Limited, India as compared to Concomitant Administration of Reference Product Forxiga 10 mg of AstraZeneca Pharma India limited., along with Pioglit® 15 mg tablets of Sun Pharma Laboratories India Ltd, in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on earlier metformin containing monotherapy. - NI
Eris Lifesciences Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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.
- •2. Patients who have ongoing mono therapy - to be enrolled and continue them with dual therapy.i.e Patients with HbA1C level greater than or equal to 7.5% to 10% and who are presently on greater than or equal to 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) greater than or equal to 45.0 kg-m2 at screening
- •5. Patients with Fasting Plasma Glucose (FPG) greater-than 240 mg-dL at screening or randomization
- •6. Patients with Estimated glomerular filtration rate (eGFR) less-than sign 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. Laboratory findings measured at screening:
- •a) Neutrophils less-than sign 2000 mm3
- •b) Platelets less-than sign100,000 mm3
- •c) Total bilirubin greater-than 1.5 X ULN
- •d) ALT- AST greater-than 2.5 X ULN
- •e) Serum amylase and-or lipase greater-than 3 X ULN
- •f) Any other screening laboratory value that is clinically significant in the Investigator’s opinion precluding patient’s participation in the study.
- •10. Patients with a history of anaemia or haemoglobinopathy and-or haemoglobin less-than sign 10 g dL for men; haemoglobin less-than sign 9 g dL for women at screening.
- •11. Patients with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and-or diastolic BP greater than or equal to 100 mmHg at screening.
- •12. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
- •13. Patients with known case of infection with hepatitis B, hepatitis C or HIV
- •14. 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.
- •15. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •16. Suspected inability or unwillingness to comply with the study procedures.
- •17. 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
相似试验
进行中（未招募）
3 期
Phase III, Randomized, Open Label,Parallel group, Multicentric clinical studyCTRI/2022/01/039154SV Pvt Ltd
已完成
3 期
Phase III Randomized Open Label Parallel Multicentric clinical studyCTRI/2022/07/044440SV Pvt Ltd202
已完成
3 期
study of drug (rhoclone) on Rh negative blood group mother giving birth to Rh positive blood group babyCTRI/2015/09/006172Bharat Serums Vaccines Limited
终止
不适用
A Phase III, Open-Label, Prospective, Randomized, Multicenter, Neo-adjuvant study of chemotherapy versus endocrine therapy in premenopausal patient with hormone responsive, HER2 negative, lymph node positive breast cancerKCT0000460Asan Medical Center290
尚未招募
3 期
Study to evaluate the efficacy and safety of Molnupiravir capsules Compare with the with Standard of Care Medications Care alone in patients who are suffering with Moderate COVID-19 diseaseCTRI/2021/08/035424Aurobindo Pharma Limited