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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications

Placebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications

Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

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

Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

NCT ID

Therapeutic Area

Metformin background therapy >/= 1500mg/day

Research Site

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Study Specific Characteristic

Hemoglobin A1c (HbA1c)

100 subjects were included in the safety and ITT population.  99 subjects were included in the evaluable population.  1 subject did not meet the I/E criteria.

Change in 24-hour mean weighted glucose (MWG) from baseline to end of treatment (Week 4) using the continuous glucose monitoring (CGM) system

Change in the 24-hour mean ampitude of glucose excursions (MAGE) from 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

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

Change in percentage of CGM readings over 24-hours with plasma glucose >180 mg/dL from
baseline to Week 4 – ITT Population

Change in fasting plasma glucose (FPG) from baseline to Week 4

Change in 4-hour mean weighted post-prandial glucose (PPG) (after the standardized breakfast meal)
from baseline to Week 4

Change in HbA1c from baseline to Week 4

Change in fructosamine from baseline to Week 4

Change in 2-hour mean weighted  PPG (after the standardized breakfast meal)
from baseline to Week 4

Change in static insulin secretion rate (10^-9 min^-1) from baseline to
Week 4 – ITT Population

Overall Study

226 subjects signed the informed consent form (ICF), and 132 subjects were screened to randomize a total of 100 subjects.

Sergey Zhuplatov MD, PhD

Change in the 24-hour mean amplitude of glucose excursion (MAGE; "distance traveled" arc length of the curve; and "energy") using the CGM (continuous glucose monitoring) system

Change in proportion of time patients had plasma glucose measurements < 70 mg/dL, >/= 70 mg/dL and </= 180 mg/dL, and >180 mg/dL

Change in 4-hour mean weighted PPG (after breakfast meal)

Change in 2-hour mean weighted PPG after the standardized breakfast meal

Difference in 24-hour glucose profile during 7-day continuous glucose monitoring (CGM) assessments

Arms	Assigned Interventions
Experimental: Farxiga with metformin or insulin Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications	Drug: Farxiga Farxiga 10mg/day Drug: Metformin Metformin background therapy >/= 1500mg/day Drug: Insulin Insulin >/= 30 units
Placebo Comparator: Placebo with metformin or insulin Placebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications	Drug: Placebo Placebo Drug: Metformin Metformin background therapy >/= 1500mg/day Drug: Insulin Insulin >/= 30 units

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

Official Title

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