Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Farxiga with metformin or insulin
Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
干预措施: Farxiga (Drug)
Farxiga with metformin or insulin
Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
干预措施: Metformin (Drug)
Farxiga with metformin or insulin
Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
干预措施: Insulin (Drug)
Placebo with metformin or insulin
Placebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
干预措施: Placebo (Drug)
Placebo with metformin or insulin
Placebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
干预措施: Metformin (Drug)
Placebo with metformin or insulin
Placebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications
干预措施: Insulin (Drug)
结局指标
主要结局
Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
时间窗: Baseline to Week 4
次要结局
- 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 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 >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)