EUCTR2009-016791-71-SK进行中（未招募）1 期
A 24-week, multicentre, randomised, double-blind, age-stratified, placebo controlled phase III study with an 80-week extension period to evaluate the efficacy and safety of dapagliflozin 10 mg once daily in patients with type 2 diabetes, cardiovascular disease and hypertension, who exhibit inadequate glycaemic control on usual care.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,175
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
- 性别
- All
入选标准
- •Inclusion criteria at enrolment (Visit 1) and start of placebo lead-in (Visits 2).
- •1.Provision of informed consent prior to any study specific procedures
- •2.Prior diagnosis of type 2 diabetes
- •3.Age at enrolment visit
- •-Men =45 years old
- •-Women =50 years old
- •4.Anti-hyperglycaemic treatment should have been used uninterrupted on a daily basis for 8 weeks and stable for at least 4 weeks before enrolment and identical to one of the defined.
- •5.At enrolment: 7.2% =HbA1c =10.5% (sample will be taken at screening)
- •6.Cardiovascular disease as defined.
- •7.Hypertension as defined
- •8.For patients on anti-hypertensive treatment, the anti-hypertensive treatment should have been used uninterrupted on a daily basis in the last 4 weeks before the enrolment.
- •9.Women not of childbearing potential or women of childbearing potential who comply with defined criteria
- •Inclusion criteria at randomisation (visit 4, laboratory values from visit 3):
- •Subject Patients should fulfil inclusion criteria number 1 to 9 (listed above) and the following criteria at randomisation:
- •10.HbA1c =7.0% and =10.0% at randomisation (value from blood sample obtained at Visit 3).
- •11.Uninterrupted monotherapy or dual combination therapy of oral diabetes drugs (with or without insulin) for at least 12 weeks before randomisation.
- •12.Insulin treatment for at least 12 weeks randomisation, if administered.
- •13.The dose of anti-hyperglycaemic drugs and the insulin regimen should be stable for 8 weeks before randomisation.
- •14.For patients on current anti-hypertensive treatment the administration of anti-hypertensive drug(s) should be uninterrupted for 8 weeks before randomisation and dose should be stable for 4 weeks before randomisation.
- •15.Lipid-lowering and/ or anti-platelet treatment should be uninterrupted for 4 weeks before randomisation, if administered.
- •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 527
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 395
排除标准
- •The following criteria apply to the enrolment, placebo lead in and randomisation visits (Visits 1, 2, and 4).
- •Endocrine and metabolic disorders
- •1.Diagnosis of Type 1 diabetes mellitus, known diagnosis of MODY or secondary diabetes mellitus
- •2.Use of 3 or more oral anti-hyperglycaemic drugs with or without insulin
- •3.History of diabetic ketoacidosis
- •4.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
- •5.FPG >270 mg/dl (>15 mmol/L) at randomisation (sample will be taken at visit 3)
- •6.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.
- •7.Diabetes insipidus
- •8.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 excludedCardiovascular disorders
- •9.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 two months prior to enrolment
- •-Less than two months post coronary artery revascularization
- •10.Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially those who are on diuretic therapy, should have careful monitoring of their volume status throughout the study.
- •11.Blood pressure:
- •-At enrolment (Visit 1):
- •Systolic BP =165 mmHg and/or diastolic BP =100 mmHg
- •-At randomisation (Visit 4):
- •Systolic BP =160 mmHg and/or diastolic BP =100 mmHg
- •Kidney disorders
- •12.Calculated creatinine clearance <60 mL/min
- •13.Urine albumin: creatinine ratio (UACR) >1800 mg/g (>203.4 mg/mmol/L)
- •14.History of unstable or rapidly progressing renal disease
- •15.Familial renal glucosuria. This condition is diagnosed as glucosuria (>1.0 mmol/L urine) in the presence of normoglycaemia in a patients without the diagnosis of diabetes mellitus
- •Hepatic disorders
- •16.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
- •17.Total bilirubin >2.0 mg/dL (34.2 µmol/L)
- •18.Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
- •19.History of drug-induced liver enzyme elevations
- •20.History of severe hepatobiliary disease or hepatotoxicity with any medication
- •Hematologic/oncologic disorders/conditions
- •21.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
- •22.History of chronic haemolytic anaemia or haemoglobinopathies (for example, sickle cell anaemia, thalassemia, sideroblastic anemia). Mild haemolysis due to artificial heart valves is not an exclusion criterion except when haemoglobin levels are too low
- •23.Donation or transfusion of blood, plasma, or platelets within the past 3 months prior to Visit 1
- •24.History of malignancy within the last 5 years, excluding successful treatment of basal or s
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