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Glucophage
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- AstraZeneca AB
- 入组人数
- 654
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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
结局指标
主要结局
未指定
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