EUCTR2011-002231-26-ES进行中（未招募）1 期
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study with a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg once daily in Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on a background combination of Metformin and Sulfonylurea - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 218
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
- •The following criteria apply to the enrolment, placebo lead-in and randomisation visits (Visits 1, 2, 3, and 4).
- •1.Provision of informed consent prior to any study specific procedures.
- •2.Diagnosis of type 2 diabetes mellitus.
- •3.Men or women age ?18 years old, the upper age limit should be based on local metformin label restrictions.
- •4.Stable dose combination therapy of metformin ³1500mg/day and at least half the maximum dose of a sulfonylurea for at least 8 weeks prior to enrolment.
- •5.HbA1c inclusion criteria:
- •·At enrolment (Visit 1) ? laboratory values from screening visit:
- •?7.7% and ?11.0%.
- •· At the randomisation visit (Visit 4) ? laboratory values from visit 3:
- •?7.0% and ?10.5%.
- •6.For women only: Women not of childbearing potential, or women of childbearing potential who comply with the following:
- •-Use a highly effective method of birth control (see below) to avoid pregnancy throughout the study and for up to 4 weeks after the study.
- •-Have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication and at each visit.
- •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 172
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •The following criteria apply to the enrolment, placebo lead-in and randomisation visits (Visits 1, 2, 3, and 4)
- •Endocrine and metabolic disorders
- •Diagnosis of Type 1 diabetes mellitus, known diagnosis of MODY or secondary diabetes mellitus
- •History of diabetic ketoacidosis
- •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
- •FPG >270 mg/dL (>15 mmol/L) ? assessed based on laboratory results from Visits 1, 2 and 3
- •BMI >45 kg/m2
- •History of bariatric surgery (ie, any surgery to treat obesity; for example, gastric banding or procedures that involve bypassing or transposing sections of the small intestine). History of liposuction is allowed
- •Diabetes insipidus
- •Thyroid-stimulating hormone (TSH) and free T4 values outside normal range; an abnormal TSH value needs to be followed up with a free T4 test. Patients with abnormal free T4 values will be excluded
- •Cardiovascular disorders
- •Recent Cardiovascular Events in a patient:
- •Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
- •Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
- •Acute Stroke or TIA within 2 months prior to enrolment
- •Less than 2 months post coronary artery revascularization prior to enrolment
- •Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure.
- •Blood pressure:
- •At enrolment (Visit 1): Systolic BP ?170 mmHg and/or diastolic BP ?110 mmHg
- •At randomisation (Visit 4): Systolic BP ?160 mmHg and/or diastolic BP ?100 mmHg
- •Kidney or urological disorders
- •Measured serum creatinine value of ?1.5 mg/dL (133 ?mol/L) for male patients and ?1.4 mg/dL (124 ?mol/L) for female patients or renal function that would preclude treatment with metformin according to local guidance
- •History of unstable or rapidly progressing renal disease
- •Familial renal glucosuria. This condition is diagnosed as glucosuria (>1.0 mmol/L urine) in the presence of normoglycaemia in patients without the diagnosis of diabetes mellitus
- •History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit, where according to the investigator a satisfactory evaluation of hematuria has not been conducted based on guidance in section 6.4.9.3
- •Hepatic disorders
- •Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
- •Total bilirubin >2.0 mg/dL (34.2 µmol/L)
- •Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
- •History of drug-induced liver enzyme elevations
- •History of severe hepatobiliary disease or hepatotoxicity with any medication
- •Hematologic/oncologic disorders/conditions
- •Haemoglobin <10 g/dL (<100 g/L) or 6.2 mmol/L for men; haemoglobin <9.0 g/dL (<90 g/L) or 5.9 mmol/L for women
- •History of chronic haemolytic anaemia or haemoglobinopathies (for example, sickle cell anaemia, thalassemia, sideroblastic anaemia). Mild haemolysis due to artificial heart valves or due to sickle cell trait is not an exclusion criterion except when haemoglobin levels are too low (as defined in haemoglobin criteria above)
- •Iron deficiency anaemia with iron therapy started in the past 12 we
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