Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Phase 4

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Farxiga with metformin or insulin	Metformin	Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Farxiga with metformin or insulin	Insulin	Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Placebo with metformin or insulin	Placebo	Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Placebo with metformin or insulin	Metformin	Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Placebo with metformin or insulin	Insulin	Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Farxiga with metformin or insulin	Farxiga	Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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