CTRI/2021/02/031471已完成4 期
A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 196
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. Provision of signed and dated, written informed consent prior to any study specific procedures according to local Indian procedure.
- •2. Male and female patients aged > 18 and above
- •3. Documented history of type 2 diabetes mellitus with HbA1c level >7.0% and = 10% at screening visit
- •4. Patients who are on a stable dose of antidiabetic drugs (including on Metformin dose between 1000-2000mg) in the past 3 months
- •5. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in
- •conjunction with spermicide must be used.
排除标准
- •1. Known allergies or contraindication to the contents of the IP, dapagliflozin or saxagliptin tablets.
- •2. Active participation in another clinical study with IP and/or investigational device
- •3. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- •4. Type 1 diabetes mellitus.
- •5. Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2
- •6. Patients with moderate to severe renal impairment (eGFR persistently <45 mL/min/1.73 m2 by CKD-EPI formula, or end-stage renal disease (ESRD) or ‘Unstable or rapidly progressing renal disease
- •7. Patients with severe hepatic impairment (Child-Pugh class C)
- •8. History of pancreatitis or pancreatic surgery
- •9.Patients with a history of any malignancy
- •10. Patients with any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrolment, as assessed by the investigator:
- •Myocardial infarction.
- •Cardiac surgery or revascularization (CABG/PTCA).
- •Unstable angina.
- •Transient ischemic attack (TIA) or significant cerebrovascular disease.
- •Unstable or previously undiagnosed arrhythmia.
- •11. History of heart failure
- •12. Severe uncontrolled hypertension defined as systolic blood pressure =180 mm Hg and/or diastolic blood pressure =110 mm Hg at any visit up to randomisation
- •13. History of diabetic ketoacidosis
- •14. Any acute/chronic systemic infections
- •15. Recurrent urogenital infections
- •16. Patients at risk for volume depletion as judged by the investigator
- •17. 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 or patient suspected or with confirmed poor protocol or medication compliance
研究者
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