EUCTR2010-019798-13-IE进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension treated with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker(ARB) and an Additional Antihypertensive Medication
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
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) Subjects must be willing and able to give signed and dated written informed consent.
- •2) Subjects must have type 2 diabetes with inadequate glycemic control, defined as
- •central laboratory HbA1c = 7.0% and = 10.5% obtained at the enrollment visit.
- •Note: A one-time central laboratory re-test of the HbA1c is allowed in subjects with
- •an initial central laboratory HbA1c of 6.9% or 10.6% who are otherwise eligible, as
- •determined by the Investigator.
- •3) Subjects must be on a stable dose of an OAD for at least 6 weeks (12 weeks for a TZD) or a stable dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks prior to enrollment, stable effective therapeutic dose of an ACEI or an ARB and one additional antihypertensive medication (either a thiazide or thiazide-like
- •diuretic or a calcium channel blocker, beta blocker, central alpha adrenergic agonist
- •or alpha adrenergic blocker) for at least 4 weeks. Stable dose is defined as a dose that has remained the same for the specified number of weeks, as mentioned above, prior to the enrollment visit (ie, same prescribed total daily dose). Minimum effective therapeutic doses of all ACEI and ARB are defined in Appendix 5.
- •4) Subjects must have inadequately controlled hypertension, defined as seated SBP = 140 and < 165 mmHg AND seated DBP = 85 and < 105 mmHg, each representing the mean of three consecutive determinations, evaluated at both the enrollment and
- •Day 1 visits.
- •5) Subjects must have a mean 24-hour blood pressure = 130/80 mmHg as determined by ambulatory blood pressure monitoring (ABPM) during lead in, measured between Day-7 and Day-1, within 1 week prior to the Day 1 randomization visit.
- •6) C-peptide = 0.8 ng/mL (0.30 nmol/L).
- •7) BMI = 45.0 kg/m2 at the enrollment visit.
- •8) Men and women ages must be = 18 and = 89 years old at the time of the enrollment visit. Men and women of childbearing potential (WOCBP) must be using an
- •acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP.
- •9) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
- •25 IU/L or equivalent units of HCG) within 72 hours prior to the start of
- •investigational product.
- •10) Women must not be breastfeeding.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 542
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •1) History of diabetes insipidus
- •2) Symptoms of poorly controlled diabetes that would preclude participation in this trial
- •including, but not limited to, marked polyuria and polydipsia with greater than 10%
- •weight loss during the 3 months prior to enrollment, or other signs and symptoms.
- •3) History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- •4) History of malignant or accelerated hypertension.
- •5) Known or suspected secondary hypertension.
- •6) Myocardial infarction.
- •7) Cardiac surgery or revascularization (coronary artery bypass surgery [CABG]/
- •percutaneous transluminal coronary angioplasty [PTCA]).
- •8) Unstable angina.
- •9) Unstable congestive heart failure (CHF).
- •10) CHF New York Heart Association (NYHA) Class III or IV. (see Appendix 1)
- •11) Transient ischemic attack (TIA) or significant cerebrovascular disease.
- •12) Unstable or previously undiagnosed arrhythmia.
- •13) Under revised Protocol #4 subjects with a history of Gout may be entered into the study.
- •14) History of unstable or rapidly progressing renal disease.
- •15) Conditions of congenital renal glucosuria.
- •16) Renal allograft
- •17) Significant hepatic disease, including but not limited to, chronic active hepatitis
- •and/or severe hepatic insufficiency.
- •18) Documented history of hepatotoxicity with any medication.
- •19) Documented history of severe hepatobiliary disease.
- •20) History of hemoglobinopathy, with the exception of sickle cell trait (SA) or
- •thalassemia minor; or chronic or recurrent hemolysis.
- •21) Donation of blood or blood products to a blood bank, blood transfusion, or
- •participation in a clinical study requiring withdrawal of > 400 mL of blood during the
- •6 weeks prior to the enrollment visit.
- •22) Malignancy within 5 years of the enrollment visit (with the exception of treated basal
- •cell or treated squamous cell carcinoma of the skin).
- •23) Known immunocompromised status, including but not limited to, individuals who
- •have undergone organ transplantation or who are positive for the human
- •immunodeficiency virus.
- •24) Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN).
- •25) Alanine aminotransferase (ALT) > 3X ULN.
- •26) Serum total bilirubin (TB) = 1.5X ULN
- •27) Serum Creatinine (SCr) = 2.0 mg/dL unless subject is on metformin then the
- •exclusionary limits will be SCr = 1.50 mg/dL (133 µmol/L) for male subjects; SCr =
- •1.40 mg/dL (124 µmol/L) for female subjects
- •28) Estimated creatinine clearance (Crcl) of < 60ml/min
- •29) Hemoglobin = 10.0 g/dL (100 g/L) for men; hemoglobin = 9.0 g/dL (90 g/L) for
- •30) Creatine kinase (CK) > 3X ULN.
- •31) Positive for hepatitis B surface antigen.
- •32) Positive for anti-hepatitis C virus antibody.
- •33) Abnormal free T4 value.
- •34) Allergies or contraindication to the contents of dapagliflozin tablets.
- •35) Obesity that would limit accurate blood pressure measurement
- •36) History of bariatric surgery or lap-band procedure.
- •37) Administration of sibutramine, phentermine, rimonabant, benzphetamine,
- •diethylpropion, methamphetamine, orlistat, and/or phendimetrazine.
- 另有 6 项未显示
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