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阿斯利康Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin IV期 226
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临床试验NCT02429258旨在研究治疗，主要针对2型糖尿病。这是一项IV期 干预性研究试验，试验状态为已完成。试验开始于2015年5月1日，共计划招募226名患者。该研究由阿斯利康主导，已于2015年10月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2017年6月14日。
简要概括
Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
详细描述
Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
官方标题
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
疾病
2型糖尿病出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- D1690L00026
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Farxiga with metformin or insulin Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications | Farxiga Farxiga 10mg/day 二甲双胍 Metformin background therapy \>/= 1500mg/day 胰岛素 Insulin \>/= 30 units |
安慰剂对照Placebo with metformin or insulin Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications | 安慰剂 Placebo 二甲双胍 Metformin background therapy \>/= 1500mg/day 胰岛素 Insulin \>/= 30 units |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System | Baseline to Week 4 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4 | Baseline to Week 4 | |
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population | Baseline to Week 4 | |
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population | Baseline to Week 4 | |
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population | Baseline to Week 4 | |
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4 | Baseline to Week 4 | |
Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4 | Baseline to Week 4 | |
Change in HbA1c From Baseline to Week 4 | Baseline to Week 4 | |
Change in Fructosamine From Baseline to Week 4 | Baseline to Week 4 | |
Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4 | Baseline to Week 4 | |
Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population | Baseline to Week 4 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Type 2 diabetes mellitus (T2DM)
- Treated with either stable dose of metformin alone > or = to 1500mg/day or stable dose of insulin > or = to 30 units/day and up to 2 OAD medications for at least 8 weeks
- Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening
- Body mass index (BMI) < or = to 45 kg/m2
- For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening
- For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening.
- Use of sulfonylureas during the 8 weeks prior to screening
- Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor
- Ingestion of any medication know to affect glucose metabolism for >7 consecutive days during the 3 months prior to screening
- Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening
阿斯利康772 个活跃的临床试验可供探索没有联系数据。
26 位于 1 个国家/地区的研究中心
Alabama
Research Site, Birmingham, Alabama, United States
Arizona
Research Site, Phoenix, Arizona, United States
California
Research Site, Huntington Park, California, United States
Research Site, Los Angeles, California, United States
Research Site, Sacramento, California, United States
Research Site, San Diego, California, United States
Research Site, West Hills, California, United States
Florida
Research Site, Cooper City, Florida, United States
Research Site, Miami, Florida, United States
Illinois
Research Site, Evanston, Illinois, United States
Maryland
Research Site, Oxon Hill, Maryland, United States
Nebraska
Research Site, Henderson, Nebraska, United States
New York
Research Site, Brooklyn, New York, United States
Research Site, Rochester, New York, United States
North Carolina
Research Site, Greensboro, North Carolina, United States
Ohio
Research Site, Cincinnati, Ohio, United States
Research Site, Dublin, Ohio, United States
Research Site, Franklin, Ohio, United States
Oregon
Research Site, Eugene, Oregon, United States
Pennsylvania
Research Site, Lansdale, Pennsylvania, United States
South Carolina
Research Site, Spartanburg, South Carolina, United States
Tennessee
Research Site, Bartlett, Tennessee, United States
Texas
Research Site, Dallas, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Hurst, Texas, United States
Washington
Research Site, Renton, Washington, United States