Foxiga Korea Local Phase 4 Study - BEYOND

Study identifier:D1690L00067

ClinicalTrials.gov identifier:NCT02564926

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Effects of Dapagliflozin Compared with Glimepiride on Body Composition in Patients with Type 2 Diabetes Inadequately Controlled with Metformin

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 4

Healthy volunteers

Study drug

Dapagliflozin, Glimepiride

Sex

All

Actual Enrollment

125

Study type

Interventional

Age

19 Years - 75 Years

Date

Study Start Date: 05 Jan 2016

Primary Completion Date: 15 Jan 2018

Study Completion Date: 15 Jan 2018

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2019 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Incheon, Republic of Korea, 21565

Location

Research Site

Seoul, Republic of Korea, 04401

Location

Research Site

Goyang-si, Republic of Korea, 10326

Location

Research Site

Wonju-si, Republic of Korea, 220-701

Location

Research Site

Changwon-si, Republic of Korea, 51353

Location

Research Site

Daejeon-si, Republic of Korea, 35233

Location

Research Site

Suwon-si, Republic of Korea, 16499

Location

Research Site

Ansan-si, Republic of Korea, 15355

Arms	Assigned Interventions
Experimental: Dapagliflozin Dapagliflozin 10mg + Metformin 1000mg	Drug: Dapagliflozin Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment
Active Comparator: Glimepiride Glimepiriide 1-2mg + Metformin 1000mg	Drug: Glimepiride Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled: 05 January 2016 Last patient last visit: 15 January 2018

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
178 patients provided informed consent. 121 patients received study treatment and were included in the SAF population. 112 patients received study treatment and had at least one post-baseline primary efficacy assessment and were included in the FAS population (56 patients in each treatment group).

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Participant Flow: Overall Study

	Dapagliflozin	Glimepiride
STARTED	60	61
COMPLETED	52	54
NOT COMPLETED	8	7

Baseline Characteristics

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

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Baseline Measures

	Dapagliflozin	Glimepiride	Total
Number of Participants [units: Participants]	60	61	121
Sex: Female, Male [units: participants]
Female	23	34	57
Male	37	27	64
Age Continuous [units: years] Mean ± Standard Deviation	54.6 ± 9.09	55.7 ± 10.24	55.2 ± 9.66
Race/Ethnicity, Customized [units: Participants] Korean	60	61	121

Outcome Measures

1. Primary Outcome Measure: Adjusted mean changes from baseline in total body fat mass by DXA scan [ Time Frame: From baseline to Week 52 ]

Measure Type	Primary
Measure Name	Adjusted mean changes from baseline in total body fat mass by DXA scan
Measure Description	Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted mean changes from baseline in total body fat mass by DXA scan [units: grams] Least Squares Mean (95% Confidence Interval)	-1485.69 (-2025.543 to -945.844)	1096.34 (556.489 to 1636.187)

Statistical Analysis 1 for Adjusted mean changes from baseline in total body fat mass by DXA scan

Groups^[1]	All groups
Method^[3]	ANCOVA
P-Value^[4]	<0.001
Other^[5]	-2.6
95% Confidence Interval	( -3.346 to -1.819 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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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2. Primary Outcome Measure: Adjusted mean changes from baseline in percentage of total body fat assessed by DXA scan [ Time Frame: From baseline to Week 52 ]

Measure Type	Primary
Measure Name	Adjusted mean changes from baseline in percentage of total body fat assessed by DXA scan
Measure Description	Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted mean changes from baseline in percentage of total body fat assessed by DXA scan [units: percent change] Least Squares Mean (95% Confidence Interval)	-1.21 (-1.821 to -0.604)	0.73 (0.123 to 1.341)

Statistical Analysis 1 for Adjusted mean changes from baseline in percentage of total body fat assessed by DXA scan

Groups^[1]	All groups
Method^[3]	ANCOVA
P-Value^[4]	<0.001
Other^[5]	-1.94
95% Confidence Interval	( -2.807 to -1.082 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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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3. Secondary Outcome Measure: Adjusted Mean Change in HbA1c at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in HbA1c at Week 52
Measure Description	Adjusted Mean Change in HbA1c at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in HbA1c at Week 52 [units: percentages] Least Squares Mean (95% Confidence Interval)	-1.00 (-1.259 to -0.745)	-0.54 (-0.802 to -0.287)

Statistical Analysis 1 for Adjusted Mean Change in HbA1c at Week 52

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.014
Other^[5]	-0.46
95% Confidence Interval	( -0.821 to -0.094 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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:
	No text entered.
[5]	Other relevant estimation information:
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4. Secondary Outcome Measure: HbA1c <7.0% at Week 52 [ Time Frame: 52 weeks ]

Measure Type	Secondary
Measure Name	HbA1c <7.0% at Week 52
Measure Description	HbA1c <7.0% at Week 52
Time Frame	52 weeks
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
HbA1c <7.0% at Week 52 [units: participants]	27	22

Statistical Analysis 1 for HbA1c <7.0% at Week 52

Groups^[1]	All groups
Method^[3]	Regression, Logistic
P-Value^[4]	0.343
Odds Ratio (OR)^[5]	1.45
95% Confidence Interval	( 0.673 to 3.113 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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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5. Secondary Outcome Measure: Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Measure Description	Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52 [units: mg/dL] Least Squares Mean (95% Confidence Interval)	-30.94 (-40.084 to -21.800)	-12.70 (-21.786 to -3.607)

Statistical Analysis 1 for Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.006
Other^[5]	-18.25
95% Confidence Interval	( -31.140 to -5.351 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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:
	No text entered.
[5]	Other relevant estimation information:
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6. Secondary Outcome Measure: Adjusted Mean Change in Total Body Weight at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Total Body Weight at Week 52
Measure Description	Adjusted Mean Change in Total Body Weight at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Total Body Weight at Week 52 [units: kg] Least Squares Mean (95% Confidence Interval)	-2.4 (-3.104 to -1.664)	1.3 (0.545 to 1.984)

Statistical Analysis 1 for Adjusted Mean Change in Total Body Weight at Week 52

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	<0.001
Other^[5]	-3.7
95% Confidence Interval	( -4.667 to -2.631 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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: Adjusted Mean Change in Waist Circumference at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Waist Circumference at Week 52
Measure Description	Adjusted Mean Change in Waist Circumference at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Waist Circumference at Week 52 [units: cm] Least Squares Mean (95% Confidence Interval)	-2.37 (-3.480 to -1.253)	-0.16 (-1.271 to 0.957)

Statistical Analysis 1 for Adjusted Mean Change in Waist Circumference at Week 52

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.006
Other^[5]	-2.21
95% Confidence Interval	( -3.785 to -0.635 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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.

8. Secondary Outcome Measure: Adjusted Mean Change in Body Mass Index (BMI) at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Measure Description	Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Body Mass Index (BMI) at Week 52 [units: kg/m^2] Least Squares Mean (95% Confidence Interval)	-0.91 (-1.172 to -0.640)	0.46 (0.194 to 0.726)

Statistical Analysis 1 for Adjusted Mean Change in Body Mass Index (BMI) at Week 52

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	<0.001
Other^[5]	-1.37
95% Confidence Interval	( -1.742 to -0.990 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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.

9. Secondary Outcome Measure: Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Measure Description	Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52 [units: mmHg] Least Squares Mean (95% Confidence Interval)	-2.18 (-5.123 to 0.766)	4.63 (1.682 to 7.570)

Statistical Analysis 1 for Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.002
Other^[5]	-6.81
95% Confidence Interval	( -10.969 to -2.641 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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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10. Secondary Outcome Measure: Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Measure Description	Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52 [units: mmHg] Least Squares Mean (95% Confidence Interval)	-0.25 (-2.523 to 2.023)	2.36 (0.092 to 4.638)

Statistical Analysis 1 for Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52

Groups^[1]	All groups
Method^[3]	Mixed Models Analysis
P-Value^[4]	0.110
Other^[5]	-2.61
95% Confidence Interval	( -5.829 to 0.600 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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: Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52
Measure Description	Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52 [units: cm^2] Least Squares Mean (95% Confidence Interval)	-16.06 (-23.806 to -8.317)	1.48 (-6.407 to 9.377)

Statistical Analysis 1 for Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52

Groups^[1]	All groups
Method^[3]	ANCOVA
P-Value^[4]	0.002
Other^[5]	-17.55
95% Confidence Interval	( -28.603 to -6.489 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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.

12. Secondary Outcome Measure: Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52
Measure Description	Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52 [units: cm^2] Least Squares Mean (95% Confidence Interval)	-5.41 (-11.804 to 0.994)	12.98 (6.462 to 19.506)

Statistical Analysis 1 for Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52

Groups^[1]	All groups
Method^[3]	ANCOVA
P-Value^[4]	<0.001
Other^[5]	-18.39
95% Confidence Interval	( -27.561 to -9.218 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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.

13. Secondary Outcome Measure: Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Measure Description	Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52 [units: ratio] Least Squares Mean (95% Confidence Interval)	-0.05 (-0.115 to 0.017)	-0.02 (-0.084 to 0.050)

Statistical Analysis 1 for Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52

Groups^[1]	All groups
Method^[3]	ANCOVA
P-Value^[4]	0.503
Other^[5]	-0.03
95% Confidence Interval	( -0.127 to 0.063 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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.

14. Secondary Outcome Measure: Adjusted Mean Change in Lean Body Mass at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Lean Body Mass at Week 52
Measure Description	Adjusted Mean Change in Lean Body Mass at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Lean Body Mass at Week 52 [units: Kg] Least Squares Mean (95% Confidence Interval)	-1.1 (-1.608 to -0.570)	0.2 (-0.329 to 0.683)

Statistical Analysis 1 for Adjusted Mean Change in Lean Body Mass at Week 52

Groups^[1]	All groups
Method^[3]	ANCOVA
P-Value^[4]	<0.001
Other^[5]	-1.3
95% Confidence Interval	( -1.992 to -0.540 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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.

15. Secondary Outcome Measure: Adjusted Mean Change in Adinopectin at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in Adinopectin at Week 52
Measure Description	Adjusted Mean Change in Adinopectin at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in Adinopectin at Week 52 [units: ng/mL] Least Squares Mean (95% Confidence Interval)	1746.66 (1296.144 to 2197.181)	1088.95 (638.431 to 1539.468)

Statistical Analysis 1 for Adjusted Mean Change in Adinopectin at Week 52

Groups^[1]	All groups
Method^[3]	ANCOVA
P-Value^[4]	0.044
Other^[5]	657.71
95% Confidence Interval	( 18.325 to 1297.101 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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.

16. Secondary Outcome Measure: Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52 [ Time Frame: From baseline to Week 52 ]

Measure Type	Secondary
Measure Name	Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Measure Description	Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Time Frame	From baseline to Week 52
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 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Measured Values

	Dapagliflozin	Glimepiride
Number of Participants Analyzed [units:participants]	56	56
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52 [units: mg/L] Least Squares Mean (95% Confidence Interval)	-0.51 (-1.030 to 0.014)	-0.39 (-0.914 to 0.131)

Statistical Analysis 1 for Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52

Groups^[1]	All groups
Method^[3]	ANCOVA
P-Value^[4]	0.756
Other^[5]	-0.12
95% Confidence Interval	( -0.858 to 0.625 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	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	52 weeks
Additional Description	No text entered.

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Serious Adverse Events

Dapagliflozin

Glimepiride

Total, serious adverse events

# participants affected / at risk

6/60 (10.00%)

6/61 (9.84%)

Infections and infestations

Pyelonephritis acute

# participants affected / at risk

0/60 (0.00%)

1/61 (1.64%)

# events

Injury, poisoning and procedural complications

Ankle fracture

# participants affected / at risk

0/60 (0.00%)

1/61 (1.64%)

# events

Injury, poisoning and procedural complications

Joint dislocation

# participants affected / at risk

0/60 (0.00%)

1/61 (1.64%)

# events

Injury, poisoning and procedural complications

Rib fracture

# participants affected / at risk

1/60 (1.67%)

0/61 (0.00%)

# events

Injury, poisoning and procedural complications

Splenic injury

# participants affected / at risk

1/60 (1.67%)

0/61 (0.00%)

# events

Injury, poisoning and procedural complications

Subdural haemorrhage

# participants affected / at risk

1/60 (1.67%)

0/61 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion

# participants affected / at risk

1/60 (1.67%)

0/61 (0.00%)

# events

Nervous system disorders

Migraine

# participants affected / at risk

0/60 (0.00%)

1/61 (1.64%)

# events

Nervous system disorders

Transient ischaemic attack

# participants affected / at risk

1/60 (1.67%)

0/61 (0.00%)

# events

Psychiatric disorders

Conversion disorder

# participants affected / at risk

1/60 (1.67%)

0/61 (0.00%)

# events

Nervous system disorders

Trigeminal neuralgia

# participants affected / at risk

0/60 (0.00%)

1/61 (1.64%)

# events

Injury, poisoning and procedural complications

Tibia fracture

# participants affected / at risk

1/60 (1.67%)

0/61 (0.00%)

# events

General disorders

Chest pain

# participants affected / at risk

0/60 (0.00%)

1/61 (1.64%)

# events

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

Other Adverse Events

Time Frame	52 weeks
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Dapagliflozin	Dapagliflozin 10mg + Metformin 1000mg
Glimepiride	Glimepiriide 1-2mg + Metformin 1000mg

Other Adverse Events

Dapagliflozin

Glimepiride

Total, other (not including serious) adverse events

# participants affected / at risk

11/60 (18.33%)

10/61 (16.39%)

Gastrointestinal disorders

Toothache

# participants affected / at risk

4/60 (6.67%)

1/61 (1.64%)

# events

Infections and infestations

Nasopharyngitis

# participants affected / at risk

4/60 (6.67%)

2/61 (3.28%)

# events

Metabolism and nutrition disorders

Hypoglycaemia

# participants affected / at risk

3/60 (5.00%)

7/61 (11.48%)

# 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: -The Institution and PI shall provide the Company with copies of any materials relating to the Study that either intends to publish (or submit for publication) or make any presentations relating to, at least 30 days in advance of publication - At the request of the Company, the Institution and PI shall withhold publication for a period of 90 days from the date on which the Company receives the material.

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:	EunYoung Kim / Local Study Specialist
Organization:	Astrazeneca, Korea
Phone	82 2 2188 0946 Ext: 0946
E-mail:	[email protected]

Documents available

D1690l00067_CSP_Redacted
Download
D1690l00067_SAP_Redacted
Download
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

D1690l00067_CSP_Redacted

D1690l00067_SAP_Redacted

Trial Results Summaries