EUCTR2007-005931-27-CZ进行中（未招募）不适用
A 24-Week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Glimepiride (a Sulphonylurea) in Subjects with Type 2 Diabetes who Have Inadequate Glycaemic Control on Glimepiride Therapy Alone
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 545
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. Provision of a written informed consent
- •2. Males and females ¡Ý 18 years of age at time of consenting
- •3. Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study and for up to 4 weeks after
- •the study in such manner that the risk of pregnancy is minimized.
- •4. Diagnosed with Type 2 diabetes
- •5. Subjects on a stable sulphonylurea monotherapy dose that is at least half the
- •maximal recommended dose for a minimum of 8 weeks duration prior to the
- •enrolment visit.
- •N.B. Subjects on glimepiride dose higher than 4 mg/day are not eligible for the
- •Inclusion criteria before lead-in period (Visit 2, laboratory values from Visit 1):
- •6. Inadequate glycaemic control, defined as A1C = 7.0 % and = 10%
- •7. FPG = 15 mmol/L (= 270 mg/dL)
- •8. C-peptide = 1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L)
- •Inclusion criteria at randomization (Visit 5, laboratory values from Visit 4 or Visit 1 for patients who skipped the lead-in period):
- •9. A1C = 7% and = 10%
- •10. FPG = 15 mmol/L (= 270 mg/dL)
- •11. C-peptide = 1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L
- •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. Type 1 diabetes, diabetes insipidus, corticosteroid-induced type 2 diabetes, and
- •history of diabetic ketoacidosis or hyperosmolar non-ketonic coma
- •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 three months prior to enrolment, or other signs and
- •3. Use of glimepiride dose higher than 4 mg/day at enrolment and 8 weeks prior to the enrolment
- •4. AST > 3 x ULN
- •5. ALT > 3 x ULN
- •6. Serum total bilirubin > 34 µmol/L (> 2.0 mg/dL)
- •7. Calculated Creatinine-Clearance < 50 ml/min (calculated by Cockcroft-Gault
- •formula) or a measured serum creatinine value of > 177 µmol/L (2mg/dL)
- •8. Urine albumin:creatinine ratio (UACR) > 1,800 mg/g (> 203.4 mg/mmol)
- •9. Creatine kinase (CK) > 3 x ULN
- •10. Haemoglobin = 100 g/L (= 10.0 g/dL) for men; haemoglobin = 95 g/L (= 9.5 g/dL) for women
- •11. Severe uncontrolled hypertension defined as systolic BP = 180 mm Hg and/or
- •diastolic BP = 110 mm Hg
- •N.B. If subject’s BP is higher than recommended target for BP control the
- •antihypertensive therapy should be optimised according to the local standards
- •12. Thyroid-stimulating hormone (TSH) values outside normal range, to be further
- •confirmed by abnormal free T4 values. Subjects with abnormal free T4 values will
- •be excluded.
- •13. Significant cardiovascular history within the past 6 months prior to the enrolment
- •visit (myocardial infarction, unstable angina, transient ischaemic attack (TIA),
- •unstable or previously undiagnosed arrhythmia, unstable chronic heart failure,
- •cardiac surgery or revascularization (CABG/PTCA))
- •14. History of malignancy within the last 5 years, excluding successful treatment of
- •basal or squamous cell skin carcinoma or in-situ carcinoma of the cervix
- •15. History of blood lipid induced eruptive xanthomas or hypertriglyceridaemia
- •induced pancreatitis
- •16. History of unstable or rapidly progressing renal disease
- •17. Known condition of congenital renal glycosuria
- •18. History of chronic haemolytic anemia, with the exception of sickle cell trait (SA) or
- •thalassemia minor.
- •19. Subjects who, in the judgement of the Investigator, may be at risk for dehydration
- •20. Pregnant or breastfeeding subjects
- •21. Body mass index (BMI) > 45.0 kg/m2
- •22. Suspicion that the patient is infected according to World Health Organisation
- •(WHO) risk categories 2 to 4 (See Appendix C)
- •23. Treatment with chronic insulin, within 24 weeks prior to Visit 1 (however, one
- •temporary period of daily insulin injections no longer than 7 days is allowed)
- •24. Replacement or chronic systemic treatment with corticosteroid, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to enrolment visit
- •25. History of bariatric surgery.
- •26. Administration of weight loss medication, including but not limited to sibutramine,
- •phentermine, orlistat, rimonabant, benzphetamine, diethylpropion,
- •methamphetamine, and/or phendimetrazine, within 30 days prior to enrolment
- •27. Treatment for Human immunodeficiency virus (HIV)/use of antiviral drugs
- •(delavirdine, indinavir, nelfinavir, ritonavir, saquinavir) and/or known
- •immunocompromised status, including subjects who have undergone organ
- •transplantation
- •28. Known hypersensitivity to dapagliflozin or glimepiride. Intolerance to
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