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临床试验/EUCTR2009-010221-39-NL
EUCTR2009-010221-39-NL进行中（未招募）不适用

An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on GlomerularFiltration Rate (GFR) in Subjects with Type 2 Diabetes who have Inadequate Glycemicand Blood Pressure (BP) ControlPharmacogenetics Blood Sample Amendment 01 (v1.0, dated 24-Jul-2009)

Bristol Myers Squibb International Corporation0 个研究点目标入组 150 人开始时间: 2009年8月31日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
150
研究概览入排标准研究者记录与标识符相似试验

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 = 6.6% and = 9.5% obtained at the enrollment visit.
  • •3) Subjects should have been receiving metformin (XR or IR) and/or SU for at least 4
  • •weeks prior to enrollment at any stable dose. Stable dose is defined as a dose that has remained the same for at least 4 weeks prior to the enrollment visit (i.e., same
  • •prescribed total daily dose).
  • •4) Subjects must have inadequate BP control, defined as seated SBP = 130 and < 165 mmHg AND/OR seated DBP = 80 and < 105 mmHg, each representing the mean of 3 consecutive determinations, evaluated at both the enrollment and Day -7
  • •5) C-peptide = 0.8 ng/ml (0.27 nmol/L) at the enrollment visit, based on central
  • •laboratory value.
  • •6) BMI = 45.0 kg/m2 at the enrollment visit.
  • •7) Men and women, ages = 18 to = 70 years old at the time of the enrollment visit.
  • •Women of childbearing potential (WOCBP) must be using an adequate method of
  • •contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
  • •WOCBP include any female who has experienced menarche and who has not
  • •undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or
  • •bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:
  • •Amenorrhea = 12 consecutive months without another cause or
  • •For women with irregular menstrual periods and on hormone replacement
  • •therapy (HRT), a documented serum follicle stimulating hormone (FSH) level
  • •= 35 mIU/mL
  • •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) WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire study period.
  • •2) Women who are pregnant or breastfeeding.
  • •3) Women with a positive pregnancy test on enrollment or prior to investigational
  • •product administration and/or injection of iohexol, and, for subjects participating in
  • •the substudy, prior to administration of radioisotopes for determination of RCM and
  • •4) Estimated GFR (eGFR) by the Modification of Diet in Renal Disease (MDRD) formula = 60 mL/min/1.73m2 and = 150 mL/min/1.73m2.
  • •5) Urine albumin to creatinine ratio (UACR) = 300 mg/g (33.9 mg/mmol/Cr).
  • •6) Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN).
  • •7) Alanine aminotransferase (ALT) > 3X ULN.
  • •8) Serum Total Bilirubin > 2 mg/dL (34.2 µmol/L).
  • •9) Serum Creatinine (Scr) = 1.50 mg/dL (133 µmol/L) for men; SCr = 1.40 mg/dL
  • •(124 µmol/L) for women.
  • •10) Hemoglobin = 10.0 g/dL (100 g/L) for men; hemoglobin = 9.0 g/dL (90 g/L) for
  • •11) Creatine kinase (CK) > 3X ULN.
  • •12) Positive for hepatitis B surface antigen.
  • •13) Positive for anti-hepatitis C virus antibody.
  • •14) Abnormal free T4 value.
  • •15) History of diabetes insipidus.
  • •16) 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.
  • •17) History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
  • •18) Myocardial infarction.
  • •19) Cardiac surgery or revascularization (coronary artery bypass surgry [CABG]/
  • •percutaneous transluminal coronary angioplasty [PTCA]).
  • •20) Unstable angina.
  • •21) Unstable congestive heart failure (CHF).
  • •22) CHF New York Heart Association (NYHA) Class III or IV. (see Appendix 3 of the protocol)
  • •23) Transient ischemic attack (TIA) or significant cerebrovascular disease.
  • •24) Unstable or previously undiagnosed arrhythmia.
  • •25) History of malignant or accelerated hypertension.
  • •26) History of gout.
  • •27) History of unstable or rapidly progressing renal disease.
  • •28) Conditions of congenital renal glucosuria.
  • •29) Significant hepatic disease, including but not limited to, chronic active hepatitis
  • •and/or severe hepatic insufficiency.
  • •30) Documented history of hepatotoxicity with any medication.
  • •31) Documented history of severe hepatobiliary disease.
  • •32) History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis.
  • •33) 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.
  • •34) Malignancy within 5 years of the enrollment visit (with the exception of treated basal cell or treated squamous cell carcinoma of the skin).
  • •35) Known immunocompromised status, including but not limited to, individuals who
  • •have undergone organ transplantation or who are positive for the human immunodeficiency virus.
  • •36) Allergies or contraindication to the contents of dapagliflozin tablets.
  • •37) History of adverse reaction to radio-contrast dye.
  • •38) Allergy or contraindication to use of thiazide diuretics.
  • •39) Administration of insulin or any other antihyperglycemic therapy (other than
  • •metformin and/or SU), at any dose and time, during the 4 weeks prior to the
  • •enrollment visit.
  • 另有 2 项未显示

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