EUCTR2008-004916-12-DE进行中（未招募）不适用
A 24-Week, International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Metformin compared with a DPP-4 inhibitor (Sitagliptin) in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 494
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Female and/or male aged =18 years and =79 years at the time of consenting
- •3. Diagnosed with type 2 diabetes
- •4. Inadequate glycaemic control, defined as HbA1c >7% and =10.5%
- •5. Ongoing treatment with metformin alone on a stable dose of =1500 mg/day for at
- •least 8 weeks prior to enrolment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of Type 1 diabetes mellitus, MODY, or secondary diabetes mellitus
- •2. Insulin therapy within 24 weeks of enrolment (with the exception of insulin use
- •during a hospitalization or during pregnancy in a patient with gestational diabetes)
- •3. History of diabetes insipidus
- •4. History of diabetic ketoacidosis or other acute or chronic metabolic acidosis
- •5. Symptoms of poorly controlled diabetes including, but not limited to, marked
- •polyuria, polydipsia and/or greater than 10% weight loss during the 3 months prior
- •to enrolment
- •6. Previous treatment with a DPP-4 inhibitor
- •7. BMI >45 kg/m2
- •8. History of unstable or rapidly progressing renal disease
- •9. Known condition of congenital renal glucosuria
- •10. History of severe hepatobiliary disease or hepatotoxicicty with any medication
- •11. Pregnant or breastfeeding patients
- •12. Treatment with glucocorticoids equivalent to oral prednisolone >10 mg
- •(betametasone >1.2 mg/dexamethasone >1.5 mg/hydrocortisone >40 mg)/day
- •within 30 days prior to enrolment; topical or inhaled corticosteroids are allowed
- •13. History of bariatric surgery
- •14. Administration of weight loss medication, including but not limited to sibutramine,
- •phentermine, orlistat, rimonabant, benzphetamine, diethylpropion,
- •methamphetamine, and/or phendimetrazine, within 30 days prior to enrolment
- •15. Treatment for Human Immunodeficiency Virus (HIV)/use of antiviral drugs
- •(delavirdine, indinavir, nelfinavir, ritonavir, saquinavir) and/or known immunocompromised status, including patients who have undergone organ
- •transplantation
- •16. Congestive heart failure defined as New York Heart Association (NYHA) class III
- •or IV (see Appendix D), unstable congestive heart failure and/or left ventricular
- •ejection fraction of = 40%
- •17. Significant cardiovascular history within the past 6 months prior to the screening
- •visit, 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
- •18. Severe respiratory failure or severe emphysema
- •19. Systolic BP =180 mmHg and/or diastolic BP =110 mmHg
- •20. Any clinically significant abnormality identified on physical examination, ECG or
- •laboratory tests, which in the judgement of the investigator would compromise the
- •patient’s safety or successful participation in the clinical study
- •21. Treatment with unstable doses of teriparatide, bisphosphonates and/or calcitonin
- •(Note: teriparatide, bisphosponates and/or calcitonin are allowed provided the dose
- •has not changed within 30 days prior to enrolment)
- •22. Patients who, in the judgment of the investigator, may be at risk for dehydration
- •23. History of chronic haemolytic anemia or haemoglobinopathies (sickle cell anemia
- •or thalassemias, sideroblatic anaemia)
- •24. History of drug-induced liver enzyme elevations
- •25. History of drug-induced myopathy or drug-induced CK elevation
- •26. Acute or chronic metabolic acidosis
- •27. History of malignancy within the last 5 years, excluding successful treatment of
- •basal or squamous cell skin carcinoma
- •28. History of alcohol abuse or illegal drug abuse within the past 12 months
- •29. Intolerance, contraindication or potential allergy to dapagliflozin, metformin,
- •sitagliptin, glimepiride, other sulfonylurea, placebo or formulation excipients
- 另有 3 项未显示
研究者
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