NL-OMON33243已完成2 期
An exploratory phase 2 study to asses the effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in subjects with type 2 Diabetes who have inadequate glycemic and blood pressure (BP) control. - MB102-035
Bristol-Myers Squibb0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1) willing and able to give signed and dated written informed consent.
- •2) type 2 diabetes with inadequate glycemic control, defined as
- •central laboratory HbA1c >= 6.6% and <= 9.5% obtained at the enrollment visit.
- •3) metformin (XR or IR) and/or SU for at least 4 weeks prior to enrollment at any stable dose.
- •4). inadequate BP control, defined as seated SBP >= 130 and < 165 mmHg AND/OR seated DBP >= 80 and < 105 mmHg
- •5) C-peptide >= 0.8 ng/ml (0.27 nmol/L)
- •6) BMI <= 45.0 kg/m2 at the enrollment visit.
- •7) Men and women, ages >= 18 to <= 70 years.
- •Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception
排除标准
- •Main exclusion criteria:
- •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 PV.
- •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 women.
- •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.
- •CV/Vascular Diseases: Any of the following CV/Vascular Diseases within 6 months
- •of the enrollment visit:
- •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)
- •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 us
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