CTRI/2023/08/056886招募中3 期
A phase III, multicenter, randomized, double-blind, parallel-group clinical trial to compare the efficacy and safety of the fixed dose combination tablets of Linagliptin, Dapagliflozin and Metformin hydrochloride [as extended release] versus fixed dose combination tablets of Linagliptin and Metformin hydrochloride [as extended release] in patients with Type 2 Diabetes Mellitus inadequately controlled on Metformin alone
Theon Pharma0 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
- 招募中
- 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. Age: 18 to 65 years [both inclusive].
- •2. Gender: Male or female patients.
- •3. All the patients willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form.
- •4. All patients with type 2 diabetes mellitus.
- •5. Patients who have inadequate glycemic control to metformin monotherapy =1000 mg/day for at least 6 weeks.
- •6. Patients with HbA1c value between 7.5% and 10.5%.
排除标准
- •1.Known hypersensitivity to linagliptin or dapagliflozin or to any of the excipients of the investigational products.
- •2.Patients with BMI = 40 kg/m2.
- •3.Laboratory findings measured at screening:
- •a. eGFR < 60 mL/min/1.73 m2 by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation
- •b. Hemoglobin <10 g/dl
- •c. Neutrophils < 2000/mm3
- •d. Platelets <100000/mm3
- •e. Total bilirubin > 1.5 times more than upper normal limit [ULN]
- •f. ALT/ AST > 2.5 times more than ULN
- •g. Serum amylase and/or lipase > 3 times more than ULN
- •h. Any other screening laboratory value that is clinically significant in the Investigator’s opinion precluding patient’s participation in the study
- •4. Patients with Type 1 Diabetes Mellitus.
- •5. Patients with fasting plasma glucose of > 270 mg/dL
- •6. Patients with hypothyroidism or hyperthyroidism
- •7. Patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease
- •8. Patients who are on dialysis
- •9. Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis etc.)
- •10. Patients with acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents
- •11. Patients with history of pancreatitis
- •12. Patients with pancreatic insulin deficiency from any cause, caloric restriction, or alcohol abuse
- •13. Patients with genital mycotic infections or urinary tract infections
- •14. Patients with hypotension requiring intervention
- •15. Patients who have used corticosteroids for one week or more within 3 months prior to screening
- •16. Patients with a prior history of heart failure
- •17. Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology
- •18. Patients who had suffered from COVID-19 within 8 weeks prior to study drug administration or patients with suspected signs and symptoms of COVID-19/ confirmed novel coronavirus infection (COVID-19)
- •19. Women of child bearing potential not practicing any acceptable methods of contraception during study. For this study, acceptable and effective methods of contraception for females include at least one of the following:
- •a. Intrauterine device placed at least 6 months prior to the first study dose and agree to follow throughout the study
- •b. Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom)
- •c. Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner)
- •d. Females who are surgically sterile
- •e. Females who are post-menopausal for at least one year
- •f. Pregnant or lactating women
- •20.Patients with clinically significant medical history, vital signs, physical examination requiring exclusion of the patient as deemed by the investigator or designee
研究者
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