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

Study identifier:D1690L00026

ClinicalTrials.gov identifier:NCT02429258

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Type II Diabetes

Phase

Phase 4

Healthy volunteers

Study drug

Farxiga, Placebo, Metformin, Insulin

Sex

All

Actual Enrollment

226

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 01 May 2015

Primary Completion Date: 01 Oct 2015

Study Completion Date: 01 Oct 2015

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2017 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Houston, TX, United States

Location

Research Site

Rochester, NY, United States

Location

Research Site

Spartanburg, SC, United States

Location

Research Site

Los Angeles, CA, United States

Location

Research Site

Evanston, IL, United States

Location

Research Site

Dublin, OH, United States

Location

Research Site

Bartlett, TN, United States

Location

Research Site

Henderson, NE, United States

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

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
226 subjects signed the informed consent form (ICF), and 132 subjects were screened to randomize a total of 100 subjects.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Participant Flow: Overall Study

	Dapagliflozin	Placebo
STARTED	50	50
COMPLETED	48	49
NOT COMPLETED	2	1
Withdrawal by Subject	2	0
Protocol Violation	0	1

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Baseline Measures

	Dapagliflozin	Placebo	Total
Number of Participants [units: Participants]	50	50	100
Age Continuous [units: Years] Mean ± Standard Deviation	56.9 ± 7.11	56.8 ± 9.71	56.9 ± 8.47
Gender, Male/Female [units: Participants]
Female	24	25	49
Male	26	25	51
Race/Ethnicity, Customized [units: Participants]
Black or African American	11	14	25
White	39	36	75
American Indian and Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
More than one race	0	0	0
Other	0	0	0
BMI [units: kg/m^2] Mean ± Standard Deviation	34.3 ± 5.92	33.2 ± 5.59	33.8 ± 5.75
Hemoglobin A1c (HbA1c) [units: Percentage] Mean ± Standard Deviation	8.31 ± 0.785	8.37 ± 0.810	8.34 ± 0.794

Outcome Measures

1. Primary Outcome Measure: 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 ]

Measure Type	Primary
Measure Name	Change in 24-hour mean weighted glucose (MWG) from baseline to end of treatment (Week 4) using the continuous glucose monitoring (CGM) system
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in 24-hour mean weighted glucose (MWG) from baseline to end of treatment (Week 4) using the continuous glucose monitoring (CGM) system [units: mg/dL] Least Squares Mean (Standard Error)	-18.2 (4.33)	5.8 (4.25)

Statistical Analysis 1 for Change in 24-hour mean weighted glucose (MWG) from baseline to end of treatment (Week 4) using the continuous glucose monitoring (CGM) system

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Mixed Models Analysis
P-Value^[4]	<0.001
Mean Difference (Final Values)^[5]	-24.0
Standard Error of the mean	± 6.08
95% Confidence Interval	( -36.1 to -12.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Additional details about a non-inferiority or equivalence analysis:
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[3]	Other relevant information, such as adjustments or degrees of freedom:
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[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[5]	Other relevant estimation information:
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2. Secondary Outcome Measure: Change in the 24-hour mean ampitude of glucose excursions (MAGE) from baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	Change in the 24-hour mean ampitude of glucose excursions (MAGE) from baseline to Week 4
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in the 24-hour mean ampitude of glucose excursions (MAGE) from baseline to Week 4 [units: mg/dL] Least Squares Mean (Standard Error)	-10.0 (4.14)	5.3 (4.06)

Statistical Analysis 1 for Change in the 24-hour mean ampitude of glucose excursions (MAGE) from baseline to Week 4

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.010
Mean Difference (Final Values)^[5]	-15.3
Standard Error of the mean	± 5.80
95% Confidence Interval	( -26.8 to -3.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
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[3]	Other relevant information, such as adjustments or degrees of freedom:
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[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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3. Secondary Outcome Measure: Change in percentage of CGM readings over 24-hours with plasma glucose <70 mg/dL from baseline to Week 4 – ITT Population [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	Change in percentage of CGM readings over 24-hours with plasma glucose <70 mg/dL from baseline to Week 4 – ITT Population
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in percentage of CGM readings over 24-hours with plasma glucose <70 mg/dL from baseline to Week 4 – ITT Population [units: Change in percentage] Least Squares Mean (Standard Error)	0.3 (0.30)	-0.6 (0.29)

Statistical Analysis 1 for Change in percentage of CGM readings over 24-hours with plasma glucose <70 mg/dL from baseline to Week 4 – ITT Population

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.023
Mean Difference (Final Values)^[5]	1.0
Standard Error of the mean	± 0.42
95% Confidence Interval	( 0.1 to 1.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
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[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[5]	Other relevant estimation information:
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4. Secondary Outcome Measure: 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 [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	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
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
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 [units: Change in percentage] Least Squares Mean (Standard Error)	12.2 (2.60)	-2.8 (2.55)

Statistical Analysis 1 for 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

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.001
Mean Difference (Final Values)^[5]	15.0
Standard Error of the mean	± 3.65
95% Confidence Interval	( 7.7 to 22.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
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[3]	Other relevant information, such as adjustments or degrees of freedom:
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[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[5]	Other relevant estimation information:
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5. Secondary Outcome Measure: Change in percentage of CGM readings over 24-hours with plasma glucose >180 mg/dL from baseline to Week 4 – ITT Population [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	Change in percentage of CGM readings over 24-hours with plasma glucose >180 mg/dL from baseline to Week 4 – ITT Population
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in percentage of CGM readings over 24-hours with plasma glucose >180 mg/dL from baseline to Week 4 – ITT Population [units: Change in percentage] Least Squares Mean (Standard Error)	-12.6 (2.65)	3.5 (2.60)

Statistical Analysis 1 for Change in percentage of CGM readings over 24-hours with plasma glucose >180 mg/dL from baseline to Week 4 – ITT Population

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.001
Mean Difference (Final Values)^[5]	-16.1
Standard Error of the mean	± 3.72
95% Confidence Interval	( -23.5 to -8.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
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[3]	Other relevant information, such as adjustments or degrees of freedom:
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[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[5]	Other relevant estimation information:
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6. Secondary Outcome Measure: Change in fasting plasma glucose (FPG) from baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	Change in fasting plasma glucose (FPG) from baseline to Week 4
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in fasting plasma glucose (FPG) from baseline to Week 4 [units: mg/dL] Least Squares Mean (Standard Error)	-26.2 (5.99)	3.6 (5.98)

Statistical Analysis 1 for Change in fasting plasma glucose (FPG) from baseline to Week 4

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.001
Mean Difference (Final Values)^[5]	-29.7
Standard Error of the mean	± 8.47
95% Confidence Interval	( -46.6 to -12.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
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7. Secondary Outcome Measure: Change in 4-hour mean weighted post-prandial glucose (PPG) (after the standardized breakfast meal) from baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	Change in 4-hour mean weighted post-prandial glucose (PPG) (after the standardized breakfast meal) from baseline to Week 4
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in 4-hour mean weighted post-prandial glucose (PPG) (after the standardized breakfast meal) from baseline to Week 4 [units: mg/dL] Least Squares Mean (Standard Error)	-50.9 (6.54)	-10.0 (6.39)

Statistical Analysis 1 for Change in 4-hour mean weighted post-prandial glucose (PPG) (after the standardized breakfast meal) from baseline to Week 4

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.001
Mean Difference (Final Values)^[5]	-40.8
Standard Error of the mean	± 9.14
95% Confidence Interval	( -59.0 to -22.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
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8. Secondary Outcome Measure: Change in HbA1c from baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	Change in HbA1c from baseline to Week 4
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in HbA1c from baseline to Week 4 [units: % Alc] Least Squares Mean (Standard Error)	-0.51 (0.07)	-0.28 (0.07)

Statistical Analysis 1 for Change in HbA1c from baseline to Week 4

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.024
Mean Difference (Final Values)^[5]	-0.23
Standard Error of the mean	± 0.10
95% Confidence Interval	( -0.43 to -0.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
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9. Secondary Outcome Measure: Change in fructosamine from baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	Change in fructosamine from baseline to Week 4
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in fructosamine from baseline to Week 4 [units: mmol/L] Least Squares Mean (Standard Error)	-20.4 (3.22)	-9.6 (3.17)

Statistical Analysis 1 for Change in fructosamine from baseline to Week 4

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.019
Mean Difference (Final Values)^[5]	-10.8
Standard Error of the mean	± 4.55
95% Confidence Interval	( -19.9 to -1.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

10. Secondary Outcome Measure: Change in 2-hour mean weighted PPG (after the standardized breakfast meal) from baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	Change in 2-hour mean weighted PPG (after the standardized breakfast meal) from baseline to Week 4
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in 2-hour mean weighted PPG (after the standardized breakfast meal) from baseline to Week 4 [units: mg/dL] Least Squares Mean (Standard Error)	-49.5 (6.61)	-13.2 (6.46)

Statistical Analysis 1 for Change in 2-hour mean weighted PPG (after the standardized breakfast meal) from baseline to Week 4

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	<0.001
Mean Difference (Final Values)^[5]	-36.3
Standard Error of the mean	± 9.25
95% Confidence Interval	( -54.7 to -17.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

11. Secondary Outcome Measure: Change in static insulin secretion rate (10^-9 min^-1) from baseline to Week 4 – ITT Population [ Time Frame: Baseline to Week 4 ]

Measure Type	Secondary
Measure Name	Change in static insulin secretion rate (10^-9 min^-1) from baseline to Week 4 – ITT Population
Measure Description
Time Frame	Baseline to Week 4
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Measured Values

	Dapagliflozin	Placebo
Number of Participants Analyzed [units:participants]	50	50
Change in static insulin secretion rate (10^-9 min^-1) from baseline to Week 4 – ITT Population [units: 10^-9 min^-1] Least Squares Mean (Standard Error)	8.4 (2.07)	1.4 (1.98)

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

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.017
Mean Difference (Final Values)^[5]	7.0
Standard Error of the mean	± 2.86
95% Confidence Interval	( 1.3 to 12.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Serious Adverse Events

	Dapagliflozin	Placebo
Total, serious adverse events
# participants affected / at risk	0/50 (0.00%)	0/50 (0.00%)

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0.05%

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin + Metformin or Insulin
Placebo	Placebo + Metformin or Insulin

Other Adverse Events

Dapagliflozin

Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

3/50 (6.00%)

Infections and infestations

Urinary Tract Infection

# participants affected / at risk

3/50 (6.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Institution & PI agree they will not use or disclose and confidential information to third parties for a period of 10 years from receipt

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Sergey Zhuplatov MD, PhD
Organization:	AstraZeneca, PLL
Phone	215-542-3222
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Trial Results Summaries