12 Week Efficacy and Safety Study of Empagliflozin (BI 10... | NCT01370005

ID	Type	Description	Link
2011-000347-25	EudraCT Number	EudraCT

Name	Class
Eli Lilly and Company	INDUSTRY

12 Week Efficacy and Safety Study of Empagliflozin (BI 10... | NCT01370005 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI 10773 low dose	Experimental	BI 10773 low dose once daily	Drug: Placebo Drug: BI 10773
BI 10773 high dose	Experimental	BI 10773 high dose once daily	Drug: BI 10773 Drug: Placebo
Placebo	Placebo Comparator	Placebo tablets matching BI 10773	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo matching BI 10773 low dose	BI 10773 low dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c Change From Baseline	Change from baseline in HbA1c after 12 weeks of treatment.	Baseline and 12 weeks
Mean 24-hour Systolic Blood Pressure Change From Baseline	Change from baseline of mean 24-hour systolic blood pressure (SBP).	Baseline and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean 24-hour Diastolic Blood Pressure Change From Baseline	Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.	Baseline and 12 weeks
Proportion of Patients With HbA1c <7%

Other Outcomes

Measure	Description	Time Frame
Confirmed Hypoglycaemic Adverse Events	Number of participants with confirmed hypoglycaemic adverse events	From drug administration until last drug administration plus seven days, up to 171 days

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1245.48.10024 Boehringer Ingelheim Investigational Site		Huntsville	Alabama		United States
1245.48.10002 Boehringer Ingelheim Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38770818	Derived	Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
35472672

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
FG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Not treated		FG0001 subjects FG0010 subjects FG0020 subjects
Adverse Event		FG0005 subjects FG0015 subjects FG0026 subjects
Lack of Efficacy		FG0001 subjects FG0010 subjects FG0020 subjects
Non compliant with protocol		FG0000 subjects FG0011 subjects FG0022 subjects
Lost to Follow-up		FG0001 subjects FG0011 subjects FG0021 subjects
Patient refusal to continue,not due toAE		FG0005 subjects FG0014 subjects FG0020 subjects
Other reason not defined above		FG0003 subjects FG0010 subjects FG0022 subjects

Arm/Group Information

ID	Title	Description
BG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
BG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
BG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00060.3± 8.8 BG00160.6± 8.5 BG00259.9± 9.7 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000103 BG001105 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

HbA1c Change From Baseline

Change from baseline in HbA1c after 12 weeks of treatment.

Full analysis set (FAS), which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Posted

Mean

Standard Deviation

percentage of HbA1c

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts
Participants	OG000271 OG001276 OG002276

Title

Denominators

Categories

Title	Measurements
	OG0000.03± 0.60 OG001-0.59± 0.63 OG002-0.63± 0.62

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.	ANCOVA	Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects	<0.0001	Hierarchical testing, no adjustment of p-values.	Mean Difference (Final Values)	-0.62	Standard Error of the Mean	0.05	2-Sided	95	-0.72	-0.52

Primary

Mean 24-hour Systolic Blood Pressure Change From Baseline

Change from baseline of mean 24-hour systolic blood pressure (SBP).

FAS, which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts
Participants

Secondary

Mean 24-hour Diastolic Blood Pressure Change From Baseline

Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.

FAS which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts

Secondary

Proportion of Patients With HbA1c <7%

Proportion of patients with HbA1c <7% after 12 weeks.

Patients in the full analysis set (FAS) and with baseline HbA1c >= 7%. Treatment assignment as randomised.

Non-completers (missing data due to early discontinuation or values after start of rescue medication) considered 'failure' was used as the imputation rule.

Posted

Number

participants

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts
Participants

Secondary

Fasting Plasma Glucose (FPG) Change From Baseline

Change from baseline in FPG after 12 weeks of treatment.

Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

mg/dL

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts
Participants

Secondary

Body Weight Change From Baseline

Change from baseline in body weight after 12 weeks of treatment.

Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts
Participants

Secondary

Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline

Change from baseline in daytime mean SBP after 12 weeks of treatment.

FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts

Secondary

Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline

Change from baseline in daytime mean DBP after 12 weeks of treatment.

FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts

Secondary

Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline

Change from baseline in nighttime mean SBP after 12 weeks of treatment.

FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts

Secondary

Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline

Change from baseline in nighttime mean DBP after 12 weeks of treatment.

FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts

Secondary

Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline

Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.

FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts

Secondary

Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline

Change from baseline in trough mean seated DBP after 12 weeks of treatment.

FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.

Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts

Secondary

Proportion of Patients Reaching Blood Pressure <130/80 mmHg

Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment

Patients in the FAS without blood pressure control at baseline. Blood pressure control is defined as DBP<80 mmHg and SBP <130 mmHg. Treatment assignment as randomised.

Non-completers (missing data due to early disc, values after start of rescue medication or changes in antihyp. therapy) considered 'failure' was used as the imputation rule.

Posted

Number

participants

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts

Secondary

Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight

A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure > 3 mmHg from baseline and reduction of weight from baseline > 2%

Patients in the full analysis set (FAS). Treatment assignment as randomised.

Non-completers (missing data due to early discontinuation, values after start of rescue medication or changes in antihypertensive therapy) considered 'failure' was used as the imputation rule.

Posted

Number

participants

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Secondary

Orthostatic Blood Pressure

Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.

Treated set for patients with available measurements at baseline and week 12. Treatment assignment as first medication taken.

Posted

Number

participants

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Confirmed Hypoglycaemic Adverse Events

Number of participants with confirmed hypoglycaemic adverse events

Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.

Posted

Number

participants

From drug administration until last drug administration plus seven days, up to 171 days

ID	Title	Description
OG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
OG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
OG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.	7	272	43	272
EG001	Empa 10mg	Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.	3	276	42	276
EG002	Empa 25mg	Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.	4	276	55	276

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Osteomyelitis	Infections and infestations	MEDDRA 15.0	Systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk EG0020 affected276 at risk
Pneumonia	Infections and infestations	MEDDRA 15.0	Systematic Assessment	EG0000 affected272 at risk EG0010 affected276 at risk EG0021 affected276 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MEDDRA 15.0	Systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk EG0020 affected276 at risk
Carotid artery thrombosis	Nervous system disorders	MEDDRA 15.0	Systematic Assessment	EG0000 affected272 at risk EG0010 affected276 at risk EG0021 affected276 at risk
Dizziness	Nervous system disorders	MEDDRA 15.0	Systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk EG0020 affected276 at risk
Acute vestibular syndrome	Ear and labyrinth disorders	MEDDRA 15.0	Systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk EG0020 affected276 at risk
Angina pectoris	Cardiac disorders	MEDDRA 15.0	Systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk EG0020 affected276 at risk
Constipation	Gastrointestinal disorders	MEDDRA 15.0	Systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk EG0020 affected276 at risk
Cholecystitis	Hepatobiliary disorders	MEDDRA 15.0	Systematic Assessment	EG0000 affected272 at risk EG0010 affected276 at risk EG0021 affected276 at risk
Cholecystitis acute	Hepatobiliary disorders	MEDDRA 15.0	Systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk EG0020 affected276 at risk
Urethral stenosis	Renal and urinary disorders	MEDDRA 15.0	Systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk EG0020 affected276 at risk
Chest pain	General disorders	MEDDRA 15.0	Systematic Assessment	EG0000 affected272 at risk EG0010 affected276 at risk EG0021 affected276 at risk
Sudden death	General disorders	MEDDRA 15.0	Systematic Assessment	EG0000 affected272 at risk EG0011 affected276 at risk EG0020 affected276 at risk
Electrocardiogram T wave inversion	Investigations	MEDDRA 15.0	Systematic Assessment	EG0000 affected272 at risk EG0010 affected276 at risk EG0021 affected276 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MEDDRA 15.0	Systematic Assessment	EG0001 affected272 at risk EG0010 affected276 at risk EG0020 affected276 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MEDDRA 15.0	Systematic Assessment	EG00026 affected272 at risk EG00115 affected276 at risk EG00220 affected276 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MEDDRA 15.0	Systematic Assessment	EG00014 affected272 at risk EG00119 affected276 at risk EG00219 affected276 at risk
Pollakiuria	Renal and urinary disorders	MEDDRA 15.0	Systematic Assessment	EG0007 affected272 at risk EG00111 affected276 at risk EG00217 affected276 at risk
Thirst	General disorders	MEDDRA 15.0	Systematic Assessment	EG0001 affected272 at risk EG0012 affected276 at risk EG00215 affected276 at risk

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.	ANCOVA	Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects	<0.0001	Hierarchical testing, no adjustment of p-values.	Mean Difference (Final Values)	-3.44	Standard Error of the Mean	0.69	2-Sided	95	-4.78	-2.09			Difference calculated as empa 10mg minus placebo	No	Superiority or Other
OG000 OG002	Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.	ANCOVA	Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects	<0.0001	Hierarchical testing, no adjustment of p-values.	Mean Difference (Final Values)	-4.16	Standard Error of the Mean	0.68	2-Sided	95	-5.50	-2.83			Difference calculated as empa 25mg minus placebo	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.	ANCOVA	Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects	0.0008	Hierarchical testing, no adjustment of p-values.	Mean Difference (Final Values)	-1.36	Standard Error of the Mean	0.40	2-Sided	95	-2.15	-0.56			Difference calculated as empa 10mg minus placebo	No	Superiority or Other
OG000 OG002	Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.	ANCOVA	Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects	<0.0001	Hierarchical testing, no adjustment of p-values.	Mean Difference (Final Values)	-1.72	Standard Error of the Mean	0.40	2-Sided	95	-2.51	-0.93			Difference calculated as empa 25mg minus placebo	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic	Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c	<0.0001		Odds Ratio (OR)	6.26			2-Sided	95	3.51	11.18				No	Superiority or Other
OG000 OG002		Regression, Logistic	Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c	<0.0001		Odds Ratio (OR)	6.59			2-Sided	95	3.70	11.75				No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG	<0.0001		Mean Difference (Final Values)	-23.76	Standard Error of the Mean	2.63	2-Sided	95	-28.91	-18.60			Difference calculated as empa 10mg minus placebo.	No	Superiority or Other
OG000 OG002		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG	<0.0001		Mean Difference (Final Values)	-30.20	Standard Error of the Mean	2.61	2-Sided	95	-35.32	-25.08			Difference calculated as empa 25mg minus placebo.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight	<0.0001		Mean Difference (Final Values)	-1.49	Standard Error of the Mean	0.18	2-Sided	95	-1.85	-1.13			Difference calculated as empa 10mg minus placebo.	No	Superiority or Other
OG000 OG002		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight	<0.0001		Mean Difference (Final Values)	-1.98	Standard Error of the Mean	0.18	2-Sided	95	-2.33	-1.62			Difference calculated as empa 10mg minus placebo.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Model includes treatment, baseline renal function, geographical region, N of antihypertensive medications, baseline HbA1c and baseline daytime SBP	<0.0001		Mean Difference (Final Values)	-3.94	Standard Error of the Mean	0.73	2-Sided	95	-5.37	-2.52			Difference calculated as empa 10mg minus placebo.	No	Superiority or Other
OG000 OG002		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime SBP	<0.0001		Mean Difference (Final Values)	-4.78	Standard Error of the Mean	0.72	2-Sided	95	-6.20	-3.36			Difference calculated as empa 25mg minus placebo.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP	0.0004		Mean Difference (Final Values)	-1.56	Standard Error of the Mean	0.44	2-Sided	95	-2.42	-0.69			Difference calculated as empa 10mg minus placebo.	No	Superiority or Other
OG000 OG002		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP	<0.0001		Mean Difference (Final Values)	-1.98	Standard Error of the Mean	0.44	2-Sided	95	-2.84	-1.12			Difference calculated as empa 25mg minus placebo.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP	0.0021		Mean Difference (Final Values)	-2.50	Standard Error of the Mean	0.81	2-Sided	95	-4.09	-0.91			Difference calculated as empa 10mg minus placebo.	No	Superiority or Other
OG000 OG002		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP	0.0003		Mean Difference (Final Values)	-2.90	Standard Error of the Mean	0.81	2-Sided	95	-4.48	-1.32			Difference calculated as empa 25mg minus placebo.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP	0.0566		Mean Difference (Final Values)	-0.95	Standard Error of the Mean	0.50	2-Sided	95	-1.93	0.03			Difference calculated as empa 10mg minus placebo.	No	Superiority or Other
OG000 OG002		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP	0.0208		Mean Difference (Final Values)	-1.15	Standard Error of the Mean	0.50	2-Sided	95	-2.12	-0.18			Difference calculated as empa 25mg minus placebo.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP	<0.0001		Mean Difference (Final Values)	-3.92	Standard Error of the Mean	0.99	2-Sided	95	-5.86	-1.98			Difference calculated as empa 10mg minus placebo.	No	Superiority or Other
OG000 OG002		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP	<0.0001		Mean Difference (Final Values)	-4.80	Standard Error of the Mean	0.98	2-Sided	95	-6.73	-2.87			Difference calculated as empa 25mg minus placebo.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP	0.0005		Mean Difference (Final Values)	-1.93	Standard Error of the Mean	0.55	2-Sided	95	-3.01	-0.84			Difference calculated as empa 10mg minus placebo.	No	Superiority or Other
OG000 OG002		ANCOVA	Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP	0.0006		Mean Difference (Final Values)	-1.89	Standard Error of the Mean	0.55	2-Sided	95	-2.97	-0.82			Difference calculated as empa 25mg minus placebo.	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic	Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c	0.0021		Odds Ratio (OR)	2.49			2-Sided	95	1.39	4.45				No	Superiority or Other
OG000 OG002		Regression, Logistic	Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c	0.0088		Odds Ratio (OR)	2.20			2-Sided	95	1.22	3.96				No	Superiority or Other

Title

Denominators

Categories

Baseline: Positive

Title	Measurements
	OG00042 OG00140 OG00251

Baseline: Negative

Title	Measurements
	OG000212 OG001219 OG002208

Week 12: Positive

Title	Measurements
	OG00051 OG00167 OG00276

Week 12: Negative

Title	Measurements
	OG000203 OG001192 OG002183

ID	Term
D003924	Diabetes Mellitus, Type 2
D006973	Hypertension