EUCTR2007-007540-10-ES进行中（未招募）不适用
Ensayo en fase III de 24 semanas, internacional, aleatorizado, de grupos paralelos, doble ciego y controlado con placebo, con un período de extensión de 24 semanas, para evaluar la eficacia y la seguridad de la dapagliflozina añadida al tratamiento de los pacientes con diabetes de tipo 2 que tienen un control insuficiente de la glucemia con insulinaA 24-week international, randomized, parallel-group, double-blind, placebo-controlled Phase III study with a 24-week extension period to evaluate the efficacy and safety of dapagliflozin therapy when added to the therapy of patients with type 2 diabetes with inadequate glycaemic control on insulin.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
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
- •Inclusion criteria at enrolment (visit 1):
- •1. Provision of a written informed consent
- •2. Men and women diagnosed with type 2 diabetes
- •3. Age =18 - =80 years at time of consenting
- •4. Patients with inadequate glycaemic control, defined as documented HbA1c =7.5%
- •and =10.5% and who are according to investigators judgement for a period of at
- •least 8 weeks prior to enrolment on a stable insulin regimen with a mean insulin
- •dose of least 30 IU of injectable insulin per day either without any other OADs or
- •with a stable dose of OADs that have been approved in combination with insulin.
- •Inclusion criteria before randomisation (visit 2):
- •1. Patients with HbA1c =7.5% and =10.5% according central laboratory values
- •measured from sample taken at visit 1 and who are on a stable insulin regimen with
- •a mean insulin dose of least 30 IU of injectable insulin per day either without any
- •other OADs or with a stable dose of OADs that have been approved in combination
- •with insulin.
- •2. Daily insulin requirements over the past seven days with insulin dose
- •documentation that does not vary more than 10% on more than one occasion of the
- •calculated mean daily insulin dose at visit two (For example for patient whose
- •calculated mean daily insulin dose at visit 2 is 50 IU, daily doses in the preceding
- •seven days with insulin dose documentation may not be <45 and >55 IU on more
- •than one occasion).
- •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 and must have a
- •negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent
- •units of HCG) within 72 hours prior to the start of study medication. 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 (defined as amenorrhea =12 consecutive
- •months; or women on hormone replacement therapy (HRT) with documented serum
- •follicle stimulating hormone (FSH) level >35mIU/mL).Even women who are using
- •oral, implanted or injectable contraceptive hormones or mechanical products such
- •as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to
- •prevent pregnancy or practicing abstinence or where the partner is sterile (eg
- •vasectomy), should be considered to be of child bearing potential.
- •4. Body Mass Index (BMI) = 45 kg/m2
- •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
- •Exclusion criteria at randomization visit (visit 2):
- •1. Clinical diagnosis of type 1 diabetes, MODY or secondary diabetes mellitus (eg
- •chronic pancreatitis, partial pancreatectomy).
- •2. Symptoms of poorly controlled diabetes that in judgement of the investigator 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
- •3. History of diabetes insipidus
- •4. Use of inhaled insulin or injectable GLP-1 receptor agonists or DPP-4 inhibitors
- •within 8 weeks of enrolment visit
- •5. Calculated Creatinine Clearance <50 ml/min/1.73m2 (calculated by Cockcroft-Gault
- •formula) or a measured serum creatinine value of >2mg/dl (177 µmol/l). Patients on
- •concomitant metformin therapy will be excluded if serum creatinine =1.5 mg/dl
- •(133 mmol/l) for male subjects and =1.4 mg/dl (124 mmol/l) for female subjects
- •6. Known condition of congenital renal glucosuria
- •7. Total bilirubin >34.2 mmol/l, >2.0 mg/dl (ULN)
- •8. Creatine kinase =3xULN
- •9. Hemoglobin =10.0 g/dl (=100 g/l) for men; hemoglobin =9.5 g/dl (=95 g/l) for
- •10. Thyroid-stimulating hormone (TSH) values outside normal range confirmed by
- •abnormal T4 values
- •11. Positive serologic evidence of current infectious liver disease including patients
- •being positive for Hepatitis B viral antibody IgM, Hepatitis B surface antigen and
- •Hepatitis C virus antibody.
- •12. Any clinically significant abnormality identified on physical examination, ECG or
- •laboratory tests, which in the judgement of the investigator would compromise the
- •patients’ safety or successful participation in the clinical study.
- •13. Significant cardiovascular history within the past 6 months prior to the screening
- •visit, defined as: myocardial infarction, unstable angina pectoris, transient ischemic
- •attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or
- •revascularization (coronary angioplasty or bypass grafts), or cerebrovascular
- •14. Pregnant or breastfeeding patients
- •15. Treatment with glucocorticoids equivalent to oral prednisolone >10 mg
- •(betametasone >1.2 mg/dexametasone >1.5 mg/hydrocortisone >40 mg)/day within
- •30 days prior to enrolment; topical or inhaled corticosteroids are allowed
- •16. History of bariatric surgery
- •17. 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
- •18. Treatment for Human immunodeficiency virus (HIV)/use of antiviral drugs
- •(delavirdine, indinavir, nelfinavir, ritonavir, saquinavir) and/or known
- •immunocompromised status, including patients who have undergone organ
- •transplantation
- •19. Intolerance, contraindication or potential allergy to dapagliflozin or placebo or
- •formulation recipients
- •20. Congestive heart failure defined as New York Heart Association (NYHA) class III
- •or IV (see Appendix D), and/or left ventricular ejection fraction of =40%
- •21. Severe respiratory failure or severe emphysema
- •22. Severe uncontrolled hypertension defined as systolic BP =180 mm Hg and/or
- •diastolic BP =110 mm Hg
- •23. Patients who, in the judgment of the investigator, may be at risk for dehydration
- •24. History of chronic hemolytic anemia or hemoglobinopathies (sickle cell anemia or
- 另有 3 项未显示
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