EUCTR2010-019511-37-DE进行中（未招募）不适用
A 16-week, Multicentre, Randomised, Double-Blind, Placebo-ControlledPhase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mgBID, 5 mg BID and 10 mg QD Versus Placebo in Patients with Type 2Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 654
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 informed consent prior to any study specific procedures
- •2. Diagnosis of T2DM
- •3. Men or women age = 18 to =77 years old at time of consenting
- •4. Current antihyperglycaemic treatment with metformin immediate release
- •formulation monotherapy =1500mg/day at a stable dose for at least 10 weeks prior
- •to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is
- •not permitted.
- •5. HbA1c =6.7% and =10.5%, based on central laboratory values from Screening
- •Visit, and Enrolment Visit 1. Note 1: In the case that Stratum 1 has met its goal for
- •randomised patients, communication will be sent out to all sites that screening and
- •enrollment will only continue for patients in Stratum 2 with an HbA1c =7.2% and
- •=10.5%. For these patients in Stratum 2, randomisation criteria of HbA1c =7.0%
- •and =10.0% will apply (see also inclusion criterion no. 6, Note 2, below).
- •6. HbA1c =6.5% and =10.0%, based on central laboratory values obtained at Visit 3,
- •one week prior to randomisation. Note 2: In the case that Stratum 1 has met its goal
- •for randomised patients, HbA1c randomisation criteria will change to those
- •applicable for Stratum 2: HbA1c =7.0% and =10.0%, based on central lab values at
- •Visit 3, one week prior to randomisation.
- •7. Women of childbearing potential (WOCBP) 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes
- •of the Young (MODY) or secondary causes of diabetes mellitus
- •2. History of diabetic ketoacidosis
- •3. 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
- •4. FPG >270 mg/dL (>15 mmol/L)
- •5. BMI > 45 kg/m2
- •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 excluded. Patients with an elevated TSH and
- •normal free T4 will be allowed if referred to their family doctor for thyroid
- •hormone replacement therapy prior to randomization
- •Kidney disorders
- •9. Creatinine Clearance: <60 mL/min (calculated by Cockcroft-Gault formula) or a
- •measured serum creatinine value of =1.5 mg/dL (133 µmol/L) for male patients and
- •=1.4 mg/dL (124 µmol/L) for female patients
- •13.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) >3xULN
- •14. Total bilirubin (TB) >2.0 mg/dL (>34.2 µmol/L)
- •15. Positive serologic evidence of current infectious liver disease including Hepatitis B
- •viral antibody IgM, Hepatitis B surface antigen and Hepatitis C virus antibody
- •16. History of drug-induced liver enzyme elevations
- •17. History of severe hepatobiliary disease or hepatotoxicity with any medication
研究者
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