Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
Overview
- Phase
- Phase 4
- Intervention
- Farxiga
- Conditions
- Type II Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 226
- Locations
- 1
- Primary Endpoint
- Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
Detailed Description
Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Farxiga with metformin or insulin
Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Intervention: Farxiga
Farxiga with metformin or insulin
Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Intervention: Metformin
Farxiga with metformin or insulin
Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Intervention: Insulin
Placebo with metformin or insulin
Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Intervention: Placebo
Placebo with metformin or insulin
Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Intervention: Metformin
Placebo with metformin or insulin
Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Intervention: Insulin
Outcomes
Primary Outcomes
Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
Time Frame: Baseline to Week 4
Secondary Outcomes
- 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)