Safety and Efficacy of Empagliflozin (BI 10773) and Sitag... | NCT01289990

ID	Type	Description	Link
2010-022718-17	EudraCT Number	EudraCT

Name	Class
Eli Lilly and Company	INDUSTRY

Safety and Efficacy of Empagliflozin (BI 10773) and Sitag... | NCT01289990 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI 10773 low (drug naive)	Experimental	BI 10773 tablets once daily	Drug: BI 10773 Drug: Placebo
BI 10773 high (drug naive)	Experimental	BI 10773 tablets once daily	Drug: Placebo Drug: BI 10773
Placebo (drug naive)	Placebo Comparator	Placebo tablets matching BI 10773 / Sitagliptin once daily	Drug: Placebo
Sitagliptin 100mg (drug naive)	Active Comparator	Sitagliptin once daily	Drug: Placebo Drug: Sitagliptin 100mg
BI 10773 low (pioglitazone)	Experimental	BI 10773 tablets once daily	Drug: BI 10773 Drug: Placebo
BI 10773 high (pioglitazone)	Experimental	BI 10773 tablets once daily

Name	Type	Description	Arm Group Labels	Other Names
BI 10773	Drug	BI 10773 tablets once daily	BI 10773 low (drug naive)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment	Change from baseline in HbA1c after 52 weeks	Baseline and 52 weeks
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment	Change from baseline in HbA1c after 76 weeks	Baseline and 76 weeks

Secondary Outcomes

Measure	Description	Time Frame
HbA1c (%) Changes From Baseline After 76 Weeks of Treatment	Change from baseline in HbA1c (%) after 76 weeks using MMRM approach	Baseline and 76 weeks
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1245.31.10145 Boehringer Ingelheim Investigational Site		Birmingham	Alabama		United States
1245.31.10162 Boehringer Ingelheim Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35472672	Derived	Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
33084149

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Empagliflozin 10 mg (Drug Naive)	Patients rolled over from trial 1245.20 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg
FG001	Empagliflozin 25 mg (Drug Naive)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Death		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects FG0042 subjects FG0051 subjects FG0060 subjects FG0070 subjects FG0080 subjects FG0090 subjects FG0100 subjects FG0111 subjects FG0120 subjects
Lost to Follow-up		FG0003 subjects FG0012 subjects FG0025 subjects FG0035 subjects FG004
Withdrawal by Subject		FG00015 subjects FG00114 subjects FG00212 subjects FG00313 subjects FG004
discontinued in preceding trial		FG00018 subjects FG00120 subjects FG00241 subjects FG00317 subjects FG004
did not continue in extension		FG00041 subjects FG00145 subjects FG00251 subjects FG00351 subjects FG004
Not treated		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Empagliflozin 10 mg (Drug Naive)	Patients rolled over from trial 1245.20 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg
BG001	Empagliflozin 25 mg (Drug Naive)	Patients rolled over from trial 1245.20 Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Sitagliptin Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg
BG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching Empagliflozin / Sitagliptin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg
BG003	Sitagliptin 100 mg (Drug Naive)	Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching Empagliflozin 25 mg Placebo: Placebo matching Empagliflozin 10 mg Sitagliptin 100 mg: Sitagliptin once daily
BG004	Empagliflozin 10 mg (Pioglitazone)	Patients rolled over from trial 1245.19 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg
BG005	Empagliflozin 25 mg (Pioglitazone)	Patients rolled over from trial 1245.19 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg
BG006	Placebo (Pioglitazone)	Patients rolled over from trial 1245.19 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg
BG007	Empagliflozin 10 mg (Metformin)	Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg Empagliflozin 10 mg: Empagliflozin 10 mg once daily
BG008	Empagliflozin 25 mg (Metformin)	Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg
BG009	Placebo (Metformin)	Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg
BG010	Empagliflozin 10 mg (Metformin+Sulfonylurea)	Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg
BG011	Empagliflozin 25 mg (Metformin+Sulfonylurea)	Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg
BG012	Placebo (Metformin+Sulfonylurea)	Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg
BG013	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
	BG00056.2± 11.6 BG00153.8± 11.6 BG00254.9± 10.9 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00082 BG00179 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

Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks

Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial.

(LOCF:Last observation carried forward)

Posted

Least Squares Mean

Standard Error

% of HbA1c

Baseline and 52 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG003	Sitagliptin 100mg (Drug Naive)	Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching BI 10773 high dose Placebo: Placebo matching BI 10773 low dose Sitagliptin 100mg: Sitagliptin once daily
OG004	BI 10773 Low (Pioglitazone)	Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose
OG005	BI 10773 High (Pioglitazone)	Patients rolled over from trial 1245.19 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG006	Placebo (Pioglitazone)	Patients rolled over from trial 1245.19 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
OG007	BI 10773 Low (Metformin)	Patients rolled over from trial 1245.23 BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose BI 10773: BI 10773 tablets once daily
OG008	BI 10773 High (Metformin)	Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG009	Placebo (Metformin)	Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose
OG010	BI 10773 Low (Metformin+Sulfonylurea)	Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 high dose
OG011	BI 10773 High (Metformin+Sulfonylurea)	Patients rolled over from trial 1245.23 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG012	Placebo (Metformin+Sulfonylurea)	Patients rolled over from trial 1245.23 Placebo tablets matching BI 10773 Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching BI 10773 high dose

Units	Counts
Participants	OG000224 OG001224 OG002228 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.70± 0.05 OG001-0.82± 0.05 OG0020.09± 0.05 OG003

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 OG002	statistical analysis at week 52	ANCOVA		<0.0001	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.79	Standard Error of the Mean	0.08	2-Sided	95	-0.94	-0.64				No	Superiority or Other

Secondary

HbA1c (%) Changes From Baseline After 76 Weeks of Treatment

Change from baseline in HbA1c (%) after 76 weeks using MMRM approach

Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (OC: Observed cases)

Posted

Least Squares Mean

Standard Error

% of HbA1c

Baseline and 76 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment

Systolic blood pressure - change from baseline after 52 weeks of treatment

Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial. (LOCF)

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and 52 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Primary

Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment

Change from baseline in HbA1c after 76 weeks

Posted

Least Squares Mean

Standard Deviation

% of HbA1c

Baseline and 76 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment

Systolic blood pressure - change from baseline after 76 weeks of treatment

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and 76 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment

Diastolic blood pressure - change from baseline after 52 weeks of treatment

Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and 52 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment

Diastolic blood pressure - change from baseline after 76 weeks of treatment

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and 76 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Body Weight (kg) Change From Baseline After 52 Weeks of Treatment

Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment

Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial. - LOCF

Posted

Least Squares Mean

Standard Error

Baseline and 52 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Body Weight (kg) Change From Baseline After 76 Weeks of Treatment

Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment

Posted

Least Squares Mean

Standard Error

Baseline and 76 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment

Waist circumference (cm) - change from baseline after 52 weeks of treatment

Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF

Posted

Least Squares Mean

Standard Error

Baseline and 52 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment

Waist circumference (cm) - change from baseline after 76 weeks of treatment

Posted

Least Squares Mean

Standard Error

Baseline and 76 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment

Fasting plasma glucose - change from baseline after 52 weeks of treatment

Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and 52 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Secondary

Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment

Fasting plasma glucose - change from baseline after 76 weeks of treatment

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and 76 weeks

ID	Title	Description
OG000	BI 10773 Low (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily BI 10773: BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose
OG001	BI 10773 High (Drug Naive)	Patients rolled over from trial 1245.20 BI 10773 tablets once daily Placebo: Placebo matching Sitagliptin BI 10773: BI 10773 tablets once daily Placebo: Placebo matching BI 10773 low dose
OG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching BI 10773 / Sitagliptin once daily Placebo: Placebo matching BI 10773 low dose Placebo: Placebo matching Sitagliptin Placebo: Placebo matching BI 10773 high dose

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Empagliflozin 10 mg (Drug Naive)	Patients rolled over from trial 1245.20 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	23	229	134	229
EG001	Empagliflozin 25 mg (Drug Naive)	Patients rolled over from trial 1245.20 Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 10 mg	25	224	110	224
EG002	Placebo (Drug Naive)	Patients rolled over from trial 1245.20 Placebo tablets matching Empagliflozin / Sitagliptin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Sitagliptin Placebo: Placebo matching Empagliflozin 25 mg	16	223	92	223
EG003	Sitagliptin 100mg (Drug Naive)	Patients rolled over from trial 1245.20 Sitagliptin once daily Placebo: Placebo matching Empagliflozin 25 mg Placebo: Placebo matching Empagliflozin 10 mg Sitagliptin 100mg: Sitagliptin once daily	18	223	116	223
EG004	Empagliflozin 10 mg (Pioglitazone)	Patients rolled over from trial 1245.19 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	11	165	110	165
EG005	Empagliflozin 25 mg (Pioglitazone)	Patients rolled over from trial 1245.19 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	13	165	96	165
EG006	Placebo (Pioglitazone)	Patients rolled over from trial 1245.19 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	15	168	107	168
EG007	Empagliflozin 10 mg (Metformin)	Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg Empagliflozin 10 mg: Empagliflozin 10 mg once daily	24	206	122	206
EG008	Empagliflozin 25 mg (Metformin)	Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	19	217	113	217
EG009	Placebo (Metformin)	Patients rolled over from trial 1245.23 Placebo tablets matching Empagliflozin once daily Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	17	214	106	214
EG010	Empagliflozin 10 mg (Metformin+Sulfonylurea)	Patients rolled over from trial 1245.23 Empagliflozin 10 mg tablets once daily Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily Placebo: Placebo matching Empagliflozin 25 mg	31	225	146	225
EG011	Empagliflozin 25 mg (Metformin+Sulfonylurea)	Patients rolled over from trial 1245.23 Empagliflozin 25 mg tablets once daily Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily Placebo: Placebo matching Empagliflozin 10 mg	29	224	147	224
EG012	Placebo (Metformin+Sulfonylurea)	Patients rolled over from 1245.23 Placebo tablets matching Empagliflozin Placebo: Placebo matching Empagliflozin 10 mg Placebo: Placebo matching Empagliflozin 25 mg	24	217	142	217

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG0030 affected223 at risk EG0040 affected165 at risk EG0052 affected165 at risk EG0061 affected168 at risk EG0071 affected206 at risk EG0080 affected217 at risk EG0090 affected214 at risk EG0100 affected225 at risk EG0111 affected224 at risk EG0120 affected217 at risk
Gastroenteritis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Pneumonia	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Urinary tract infection	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Amoebic colitis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cervicitis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Dengue fever	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Pseudomonas infection	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Pyelonephritis acute	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Septic shock	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Urosepsis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Anal abscess	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Appendicitis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Gangrene	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Herpes zoster	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Sepsis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Subcutaneous abscess	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Atypical pneumonia	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cytomegalovirus infection	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Genital infection	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Herpes virus infection	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Infected skin ulcer	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Listeria sepsis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Peritonitis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Salmonellosis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Schistosomiasis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Upper respiratory tract infection	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Anaplastic large cell lymphoma T- and null-cell types	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Gastrooesophageal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hypersensitivity	Immune system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Empty sella syndrome	Endocrine disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Goitre	Endocrine disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Hyperparathyroidism	Endocrine disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Dehydration	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Insulin-requiring type 2 diabetes mellitus	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Stress	Psychiatric disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cerebral infarction	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Cerebrovascular accident	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0012 affected224 at risk EG0020 affected223 at risk EG003
Brain stem infarction	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Carotid artery stenosis	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Presyncope	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Brain stem stroke	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Carotid artery disease	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cerebral ischaemia	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Diabetic neuropathy	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Dizziness	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Lacunar infarction	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Radiculitis brachial	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Syncope	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Transient ischaemic attack	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Convulsion	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Intercostal neuralgia	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Ischaemic stroke	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Sciatica	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Vascular headache	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Diabetic retinopathy	Eye disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cataract	Eye disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Dacryostenosis acquired	Eye disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Glaucoma	Eye disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Lens dislocation	Eye disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Retinal detachment	Eye disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Retinal vein occlusion	Eye disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Vitreous haemorrhage	Eye disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Sudden hearing loss	Ear and labyrinth disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Tinnitus	Ear and labyrinth disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Vertigo	Ear and labyrinth disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Meniere's disease	Ear and labyrinth disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Coronary artery disease	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Acute myocardial infarction	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0022 affected223 at risk EG003
Angina pectoris	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Acute coronary syndrome	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Angina unstable	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Atrial fibrillation	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Atrial flutter	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Myocardial ischaemia	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cardiac failure	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cardiac failure congestive	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Myocardial infarction	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Prinzmetal angina	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Aortic valve stenosis	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Ventricular tachycardia	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cardiogenic shock	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Left ventricular failure	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Acute left ventricular failure	Cardiac disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Femoral artery occlusion	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Haematoma	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Vascular calcification	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Vascular occlusion	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Deep vein thrombosis	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hypertension	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Ischaemia	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Arterial occlusive disease	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Venous occlusion	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Upper airway resistance syndrome	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Gastritis	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0002 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Anal fissure	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Constipation	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Oesophageal rupture	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Gastric polyps	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Nausea	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Vomiting	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Abdominal pain	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Faecaloma	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cholecystitis	Hepatobiliary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Liver injury	Hepatobiliary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hepatitis toxic	Hepatobiliary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cirrhosis alcoholic	Hepatobiliary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Liver disorder	Hepatobiliary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Jaundice	Hepatobiliary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0002 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Osteoarthropathy	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Femoroacetabular impingement	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Plica syndrome	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Renal failure acute	Renal and urinary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Cystitis haemorrhagic	Renal and urinary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Dysuria	Renal and urinary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hypotonic urinary bladder	Renal and urinary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Polyuria	Renal and urinary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Renal failure	Renal and urinary disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Breast mass	Reproductive system and breast disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Gilbert's syndrome	Congenital, familial and genetic disorders	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Phimosis	Congenital, familial and genetic disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Syringomyelia	Congenital, familial and genetic disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Chest pain	General disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Death	General disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Chest discomfort	General disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Non-cardiac chest pain	General disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Hernia	General disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Impaired healing	General disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Sudden death	General disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Haemoglobin decreased	Investigations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Blood creatine phosphokinase increased	Investigations	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Blood creatinine increased	Investigations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Smear cervix abnormal	Investigations	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Comminuted fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Fall	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Injury	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Traumatic fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected223 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Neck injury	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Knee arthroplasty	Surgical and medical procedures	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected223 at risk EG003
Photocoagulation	Surgical and medical procedures	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Vitrectomy	Surgical and medical procedures	MEDDRA 16.0	Systematic Assessment	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Leg amputation	Surgical and medical procedures	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG00021 affected229 at risk EG00120 affected224 at risk EG00213 affected223 at risk EG00318 affected223 at risk EG00433 affected165 at risk EG00529 affected165 at risk EG00633 affected168 at risk EG00723 affected206 at risk EG00825 affected217 at risk EG00918 affected214 at risk EG01028 affected225 at risk EG01133 affected224 at risk EG01233 affected217 at risk
Nasopharyngitis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG00027 affected229 at risk EG00132 affected224 at risk EG00225 affected223 at risk EG003
Upper respiratory tract infection	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG00012 affected229 at risk EG00117 affected224 at risk EG00216 affected223 at risk EG003
Bronchitis	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG00010 affected229 at risk EG00111 affected224 at risk EG0026 affected223 at risk EG003
Influenza	Infections and infestations	MEDDRA 16.0	Systematic Assessment	EG0009 affected229 at risk EG0016 affected224 at risk EG0026 affected223 at risk EG003
Anaemia	Blood and lymphatic system disorders	MEDDRA 16.0	Systematic Assessment	EG0008 affected229 at risk EG0012 affected224 at risk EG0022 affected223 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG00063 affected229 at risk EG00120 affected224 at risk EG00211 affected223 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0003 affected229 at risk EG0014 affected224 at risk EG0022 affected223 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG00015 affected229 at risk EG00116 affected224 at risk EG00214 affected223 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MEDDRA 16.0	Systematic Assessment	EG0000 affected229 at risk EG0010 affected224 at risk EG0020 affected223 at risk EG003
Dizziness	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0006 affected229 at risk EG0016 affected224 at risk EG0026 affected223 at risk EG003
Headache	Nervous system disorders	MEDDRA 16.0	Systematic Assessment	EG0009 affected229 at risk EG00110 affected224 at risk EG0026 affected223 at risk EG003
Hypertension	Vascular disorders	MEDDRA 16.0	Systematic Assessment	EG00012 affected229 at risk EG00111 affected224 at risk EG0025 affected223 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MEDDRA 16.0	Systematic Assessment	EG0006 affected229 at risk EG0019 affected224 at risk EG0023 affected223 at risk EG003
Dyspepsia	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0002 affected229 at risk EG0011 affected224 at risk EG0022 affected223 at risk EG003
Diarrhoea	Gastrointestinal disorders	MEDDRA 16.0	Systematic Assessment	EG0009 affected229 at risk EG00112 affected224 at risk EG0026 affected223 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG00011 affected229 at risk EG0017 affected224 at risk EG0027 affected223 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MEDDRA 16.0	Systematic Assessment	EG00011 affected229 at risk EG0019 affected224 at risk EG00210 affected223 at risk EG003
Glycosylated haemoglobin increased	Investigations	MEDDRA 16.0	Systematic Assessment	EG0009 affected229 at risk EG00110 affected224 at risk EG0021 affected223 at risk EG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.70± 0.07 OG001-0.77± 0.07 OG0020.13± 0.08 OG003-0.48± 0.07 OG004-0.67± 0.09 OG005-0.77± 0.08 OG006-0.05± 0.12 OG007-0.60± 0.06 OG008-0.76± 0.07 OG0090.07± 0.08 OG010-0.75± 0.08 OG011-0.75± 0.08 OG0120.06± 0.09

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	Mixed Models Analysis	<0.0001	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.82	Standard Error of the Mean	0.11	2-Sided	95	-1.04	-0.61	No	Superiority or Other
OG001 OG002	Mixed Models Analysis	<0.0001	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.90	Standard Error of the Mean	0.11	2-Sided	95	-1.11	-0.69	No	Superiority or Other
OG000 OG003	Mixed Models Analysis	0.0322	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.21	Standard Error of the Mean	0.10	2-Sided	95	-0.41	-0.02	No	Superiority or Other
OG001 OG003	Mixed Models Analysis	0.0038	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.29	Standard Error of the Mean	0.10	2-Sided	95	-0.48	-0.09	No	Superiority or Other
OG002 OG003	Mixed Models Analysis	<0.0001	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.61	Standard Error of the Mean	0.11	2-Sided	95	-0.83	-0.40	No	Superiority or Other
OG004 OG006	Mixed Models Analysis	<0.0001	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.62	Standard Error of the Mean	0.15	2-Sided	95	-0.90	-0.33	No	Superiority or Other
OG005 OG006	Mixed Models Analysis	<0.0001	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.72	Standard Error of the Mean	0.14	2-Sided	95	-1.00	-0.44	No	Superiority or Other
OG007 OG009	Mixed Models Analysis	<0.0001	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.67	Standard Error of the Mean	0.10	2-Sided	95	-0.87	-0.47	No	Superiority or Other
OG008 OG009	Mixed Models Analysis	<0.0001	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.83	Standard Error of the Mean	0.10	2-Sided	95	-1.04	-0.63	No	Superiority or Other
OG010 OG012	Mixed Models Analysis	<0.0001	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.80	Standard Error of the Mean	0.12	2-Sided	95	-1.04	-0.57	No	Superiority or Other
OG011 OG012	Mixed Models Analysis	<0.0001	Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.	Adjusted mean difference	-0.80	Standard Error of the Mean	0.12	2-Sided	95	-1.04	-0.56	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-4.9± 0.8 OG001-4.5± 0.8 OG002-1.6± 0.8 OG003-0.2± 0.8 OG004-1.8± 0.9 OG005-3.3± 0.9 OG0060.6± 0.9 OG007-3.6± 0.7 OG008-5.2± 0.7 OG009-0.7± 0.7 OG010-3.1± 0.7 OG011-2.7± 0.7 OG012-0.2± 0.7

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	<0.0001	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-4.6	Standard Error of the Mean	1.1	2-Sided	95	-6.8	-2.5	No	Superiority or Other
OG001 OG002	ANCOVA	0.0001	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-4.2	Standard Error of the Mean	1.1	2-Sided	95	-6.4	-2.1	No	Superiority or Other
OG002 OG003	ANCOVA	0.2107	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.4	Standard Error of the Mean	1.1	2-Sided	95	-3.5	0.8	No	Superiority or Other
OG000 OG003	ANCOVA	0.0033	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-3.3	Standard Error of the Mean	1.1	2-Sided	95	-5.4	-1.1	No	Superiority or Other
OG001 OG003	ANCOVA	0.0105	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.8	Standard Error of the Mean	1.1	2-Sided	95	-5.0	-0.7	No	Superiority or Other
OG004 OG006	ANCOVA	0.0543	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.4	Standard Error of the Mean	1.3	2-Sided	95	-4.9	0.0	No	Superiority or Other
OG005 OG006	ANCOVA	0.0019	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-3.9	Standard Error of the Mean	1.2	2-Sided	95	-6.4	-1.5	No	Superiority or Other
OG007 OG009	ANCOVA	0.0045	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-3.0	Standard Error of the Mean	1.0	2-Sided	95	-5.0	-0.9	No	Superiority or Other
OG008 OG009	ANCOVA	<0.0001	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-4.5	Standard Error of the Mean	1.0	2-Sided	95	-6.6	-2.5	No	Superiority or Other
OG010 OG012	ANCOVA	0.0031	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.9	Standard Error of the Mean	1.0	2-Sided	95	-4.8	-1.0	No	Superiority or Other
OG011 OG012	ANCOVA	0.0096	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.5	Standard Error of the Mean	1.0	2-Sided	95	-4.4	-0.6	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-0.65± 0.06 OG001-0.76± 0.06 OG0020.13± 0.06 OG003-0.53± 0.06 OG004-0.61± 0.07 OG005-0.70± 0.07 OG006-0.01± 0.07 OG007-0.62± 0.05 OG008-0.74± 0.05 OG009-0.01± 0.05 OG010-0.74± 0.06 OG011-0.72± 0.06 OG012-0.03± 0.06

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	<0.0001	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.78	Standard Error of the Mean	0.08	2-Sided	95	-0.94	-0.63	No	Superiority or Other
OG001 OG002	ANCOVA	<0.0001	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.89	Standard Error of the Mean	0.08	2-Sided	95	-1.04	-0.73	No	Superiority or Other
OG002 OG003	ANCOVA	<0.0001	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.66	Standard Error of the Mean	0.08	2-Sided	95	-0.82	-0.51	No	Superiority or Other
OG000 OG003	ANCOVA	0.1310	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.12	Standard Error of the Mean	0.08	2-Sided	95	-0.28	0.04	No	Superiority or Other
OG001 OG003	ANCOVA	0.0050	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.22	Standard Error of the Mean	0.08	2-Sided	95	-0.38	-0.07	No	Superiority or Other
OG004 OG006	ANCOVA	<0.0001	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.59	Standard Error of the Mean	0.10	2-Sided	95	-0.79	-0.40	No	Superiority or Other
OG005 OG006	ANCOVA	<0.0001	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.69	Standard Error of the Mean	0.10	2-Sided	95	-0.88	-0.50	No	Superiority or Other
OG007 OG009	ANCOVA	<0.0001	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.61	Standard Error of the Mean	0.07	2-Sided	95	-0.75	-0.46	No	Superiority or Other
OG008 OG009	ANCOVA	<0.0001	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.73	Standard Error of the Mean	0.07	2-Sided	95	-0.88	-0.58	No	Superiority or Other
OG010 OG012	ANCOVA	<0.0001		Adjusted mean difference	-0.72	Standard Error of the Mean	0.08	2-Sided	95	-0.87	-0.56	No	Superiority or Other
OG011 OG012	ANCOVA	<0.0001	Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.69	Standard Error of the Mean	0.08	2-Sided	95	-0.85	-0.53	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-4.1± 0.8 OG001-4.2± 0.8 OG002-0.7± 0.8 OG003-0.3± 0.8 OG004-1.7± 0.9 OG005-3.4± 0.9 OG0060.3± 0.9 OG007-5.2± 0.8 OG008-4.5± 0.8 OG009-0.8± 0.8 OG010-3.8± 0.7 OG011-3.7± 0.7 OG012-1.6± 0.7

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	0.0025	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-3.4	Standard Error of the Mean	1.1	2-Sided	95	-5.5	-1.2	No	Superiority or Other
OG001 OG002	ANCOVA	0.0021	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-3.4	Standard Error of the Mean	1.1	2-Sided	95	-5.6	-1.2	No	Superiority or Other
OG002 OG003	ANCOVA	0.7241	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	0.4	Standard Error of the Mean	1.1	2-Sided	95	-1.8	2.6	No	Superiority or Other
OG000 OG003	ANCOVA	0.0008	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-3.7	Standard Error of the Mean	1.1	2-Sided	95	-5.9	-1.6	No	Superiority or Other
OG001 OG003	ANCOVA	0.0007	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-3.8	Standard Error of the Mean	1.1	2-Sided	95	-6.0	-1.6	No	Superiority or Other
OG004 OG006	ANCOVA	0.0987	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.0	Standard Error of the Mean	1.2	2-Sided	95	-4.5	0.4	No	Superiority or Other
OG005 OG006	ANCOVA	0.0028	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-3.7	Standard Error of the Mean	1.2	2-Sided	95	-6.1	-1.3	No	Superiority or Other
OG007 OG009	ANCOVA	<0.0001	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-4.4	Standard Error of the Mean	1.1	2-Sided	95	-6.6	-2.3	No	Superiority or Other
OG008 OG009	ANCOVA	0.0008	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-3.7	Standard Error of the Mean	1.1	2-Sided	95	-5.9	-1.5	No	Superiority or Other
OG010 OG012	ANCOVA	0.0213	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.2	Standard Error of the Mean	1.0	2-Sided	95	-4.1	-0.3	No	Superiority or Other
OG011 OG012	ANCOVA	0.0288	Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.1	Standard Error of the Mean	1.0	2-Sided	95	-4.1	-0.2	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-1.3± 0.5 OG001-1.9± 0.5 OG002-0.2± 0.5 OG003-0.3± 0.5 OG004-1.6± 0.5 OG005-2.2± 0.5 OG0060.4± 0.5 OG007-2.2± 0.5 OG008-2.1± 0.5 OG009-0.4± 0.5 OG010-1.7± 0.5 OG011-1.6± 0.5 OG012-1.0± 0.5

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	0.1058	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.1	Standard Error of the Mean	0.7	2-Sided	95	-2.4	0.2	No	Superiority or Other
OG001 OG002	ANCOVA	0.0109	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.7	Standard Error of the Mean	0.7	2-Sided	95	-3.1	-0.4	No	Superiority or Other
OG002 OG003	ANCOVA	0.8259	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.2	Standard Error of the Mean	0.7	2-Sided	95	-1.5	1.2	No	Superiority or Other
OG000 OG003	ANCOVA	0.1660	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.9	Standard Error of the Mean	0.7	2-Sided	95	-2.3	0.4	No	Superiority or Other
OG001 OG003	ANCOVA	0.0212	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.6	Standard Error of the Mean	0.7	2-Sided	95	-2.9	-0.2	No	Superiority or Other
OG004 OG006	ANCOVA	0.0076	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.0	Standard Error of the Mean	0.7	2-Sided	95	-3.4	-0.5	No	Superiority or Other
OG005 OG006	ANCOVA	0.0003	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.6	Standard Error of the Mean	0.7	2-Sided	95	-4.1	-1.2	No	Superiority or Other
OG007 OG009	ANCOVA	0.0170	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.8	Standard Error of the Mean	0.7	2-Sided	95	-3.2	-0.3	No	Superiority or Other
OG008 OG009	ANCOVA	0.0236	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.7	Standard Error of the Mean	0.7	2-Sided	95	-3.1	-0.2	No	Superiority or Other
OG010 OG012	ANCOVA	0.2523	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.7	Standard Error of the Mean	0.6	2-Sided	95	-2.0	0.5	No	Superiority or Other
OG011 OG012	ANCOVA	0.3494	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.6	Standard Error of the Mean	0.6	2-Sided	95	-1.9	0.7	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-1.6± 0.5 OG001-1.6± 0.5 OG002-0.6± 0.5 OG003-0.1± 0.5 OG004-1.3± 0.5 OG005-2.0± 0.5 OG0060.2± 0.5 OG007-2.5± 0.5 OG008-1.9± 0.5 OG009-0.5± 0.5 OG010-2.6± 0.5 OG011-2.3± 0.5 OG012-1.4± 0.5

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	0.1568	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.0	Standard Error of the Mean	0.7	2-Sided	95	-2.3	0.4	No	Superiority or Other
OG001 OG002	ANCOVA	0.1323	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.0	Standard Error of the Mean	0.7	2-Sided	95	-2.4	0.3	No	Superiority or Other
OG002 OG003	ANCOVA	0.4327	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	0.5	Standard Error of the Mean	0.7	2-Sided	95	-0.8	1.9	No	Superiority or Other
OG000 OG003	ANCOVA	0.0289	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.5	Standard Error of the Mean	0.7	2-Sided	95	-2.8	-0.2	No	Superiority or Other
OG001 OG003	ANCOVA	0.0231	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.6	Standard Error of the Mean	0.7	2-Sided	95	-2.9	-0.2	No	Superiority or Other
OG004 OG006	ANCOVA	0.0513	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.5	Standard Error of the Mean	0.8	2-Sided	95	-3.0	0.0	No	Superiority or Other
OG005 OG006	ANCOVA	0.0038	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.2	Standard Error of the Mean	0.8	2-Sided	95	-3.7	-0.7	No	Superiority or Other
OG007 OG009	ANCOVA	0.0084	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.0	Standard Error of the Mean	0.7	2-Sided	95	-3.4	-0.5	No	Superiority or Other
OG008 OG009	ANCOVA	0.0677	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.4	Standard Error of the Mean	0.7	2-Sided	95	-2.8	0.1	No	Superiority or Other
OG010 OG012	ANCOVA	0.0814	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.1	Standard Error of the Mean	0.7	2-Sided	95	-2.4	0.1	No	Superiority or Other
OG011 OG012	ANCOVA	0.1785	Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.9	Standard Error of the Mean	0.7	2-Sided	95	-2.2	0.4	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-2.70± 0.19 OG001-2.61± 0.19 OG002-0.48± 0.19 OG0030.14± 0.19 OG004-1.50± 0.24 OG005-1.40± 0.24 OG0060.59± 0.24 OG007-2.27± 0.19 OG008-2.84± 0.19 OG009-0.54± 0.20 OG010-2.28± 0.18 OG011-2.32± 0.19 OG012-0.31± 0.18

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.22	Standard Error of the Mean	0.27	2-Sided	95	-2.75	-1.69	No	Superiority or Other
OG001 OG002	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.14	Standard Error of the Mean	0.27	2-Sided	95	-2.66	-1.61	No	Superiority or Other
OG002 OG003	ANCOVA	0.0223	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	0.62	Standard Error of the Mean	0.27	2-Sided	95	0.09	1.14	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.84	Standard Error of the Mean	0.27	2-Sided	95	-3.37	-2.31	No	Superiority or Other
OG001 OG003	ANCOVA	<0.0001		Adjusted mean difference	-2.75	Standard Error of the Mean	0.27	2-Sided	95	-3.28	-2.22	No	Superiority or Other
OG004 OG006	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.09	Standard Error of the Mean	0.34	2-Sided	95	-2.76	-1.41	No	Superiority or Other
OG005 OG006	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.99	Standard Error of the Mean	0.34	2-Sided	95	-2.66	-1.32	No	Superiority or Other
OG007 OG009	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.73	Standard Error of the Mean	0.28	2-Sided	95	-2.27	-1.19	No	Superiority or Other
OG008 OG009	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.30	Standard Error of the Mean	0.28	2-Sided	95	-2.85	-1.76	No	Superiority or Other
OG010 OG012	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.97	Standard Error of the Mean	0.26	2-Sided	95	-2.48	-1.47	No	Superiority or Other
OG011 OG012	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.01	Standard Error of the Mean	0.26	2-Sided	95	-2.52	-1.50	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-2.24± 0.20 OG001-2.45± 0.20 OG002-0.43± 0.20 OG0030.10± 0.20 OG004-1.47± 0.26 OG005-1.21± 0.26 OG0060.50± 0.26 OG007-2.39± 0.21 OG008-2.65± 0.22 OG009-0.46± 0.22 OG010-2.44± 0.19 OG011-2.28± 0.20 OG012-0.63± 0.19

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.81	Standard Error of the Mean	0.28	2-Sided	95	-2.35	-1.26	No	Superiority or Other
OG001 OG002	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.02	Standard Error of the Mean	0.28	2-Sided	95	-2.56	-1.48	No	Superiority or Other
OG002 OG003	ANCOVA	0.0546	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	0.54	Standard Error of the Mean	0.28	2-Sided	95	-0.01	1.08	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.34	Standard Error of the Mean	0.28	2-Sided	95	-2.89	-1.80	No	Superiority or Other
OG001 OG003	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.56	Standard Error of the Mean	0.28	2-Sided	95	-3.10	-2.01	No	Superiority or Other
OG004 OG006	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.97	Standard Error of the Mean	0.37	2-Sided	95	-2.69	-1.24	No	Superiority or Other
OG005 OG006	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.71	Standard Error of the Mean	0.37	2-Sided	95	-2.43	-0.99	No	Superiority or Other
OG007 OG009	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.93	Standard Error of the Mean	0.30	2-Sided	95	-2.52	-1.34	No	Superiority or Other
OG008 OG009	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.19	Standard Error of the Mean	0.30	2-Sided	95	-2.79	-1.60	No	Superiority or Other
OG010 OG012	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.81	Standard Error of the Mean	0.27	2-Sided	95	-2.34	-1.27	No	Superiority or Other
OG011 OG012	ANCOVA	<0.0001	Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.64	Standard Error of the Mean	0.27	2-Sided	95	-2.18	-1.11	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-2.0± 0.4 OG001-1.7± 0.4 OG0020.1± 0.4 OG0030.4± 0.4 OG004-1.5± 0.4 OG005-1.1± 0.4 OG006-0.1± 0.4 OG007-1.5± 0.3 OG008-2.0± 0.3 OG009-0.4± 0.3 OG010-1.5± 0.3 OG011-1.5± 0.3 OG012-0.2± 0.3

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	0.0001	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.1	Standard Error of the Mean	0.5	2-Sided	95	-3.1	-1.0	No	Superiority or Other
OG001 OG002	ANCOVA	0.0015	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.7	Standard Error of the Mean	0.5	2-Sided	95	-2.8	-0.7	No	Superiority or Other
OG002 OG003	ANCOVA	0.5052	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	0.4	Standard Error of the Mean	0.5	2-Sided	95	-0.7	1.4	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.4	Standard Error of the Mean	0.5	2-Sided	95	-3.5	-1.4	No	Superiority or Other
OG001 OG003	ANCOVA	0.0001	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.1	Standard Error of the Mean	0.5	2-Sided	95	-3.1	-1.0	No	Superiority or Other
OG004 OG006	ANCOVA	0.0064	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.5	Standard Error of the Mean	0.5	2-Sided	95	-2.6	-0.4	No	Superiority or Other
OG005 OG006	ANCOVA	0.0642	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.0	Standard Error of the Mean	0.5	2-Sided	95	-2.1	0.1	No	Superiority or Other
OG007 OG009	ANCOVA	0.0053	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.0	Standard Error of the Mean	0.4	2-Sided	95	-1.8	-0.3	No	Superiority or Other
OG008 OG009	ANCOVA	<0.0001		Adjusted mean difference	-1.6	Standard Error of the Mean	0.4	2-Sided	95	-2.3	-0.9	No	Superiority or Other
OG010 OG012	ANCOVA	0.0010	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.3	Standard Error of the Mean	0.4	2-Sided	95	-2.1	-0.6	No	Superiority or Other
OG011 OG012	ANCOVA	0.0015	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.3	Standard Error of the Mean	0.4	2-Sided	95	-2.1	-0.5	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-1.5± 0.4 OG001-1.6± 0.4 OG0020.1± 0.4 OG0030.5± 0.4 OG004-1.4± 0.4 OG005-0.9± 0.4 OG0060.0± 0.4 OG007-1.8± 0.3 OG008-1.3± 0.3 OG009-0.2± 0.3 OG010-1.6± 0.3 OG011-1.4± 0.3 OG012-0.3± 0.3

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	0.0028	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.6	Standard Error of the Mean	0.5	2-Sided	95	-2.7	-0.6	No	Superiority or Other
OG001 OG002	ANCOVA	0.0019	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.7	Standard Error of the Mean	0.5	2-Sided	95	-2.8	-0.6	No	Superiority or Other
OG002 OG003	ANCOVA	0.5044	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	0.4	Standard Error of the Mean	0.6	2-Sided	95	-0.7	1.5	No	Superiority or Other
OG000 OG003	ANCOVA	0.0003	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.0	Standard Error of the Mean	0.6	2-Sided	95	-3.1	-0.9	No	Superiority or Other
OG001 OG003	ANCOVA	0.0002	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-2.1	Standard Error of the Mean	0.6	2-Sided	95	-3.2	-1.0	No	Superiority or Other
OG004 OG006	ANCOVA	0.0109	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.4	Standard Error of the Mean	0.6	2-Sided	95	-2.5	-0.3	No	Superiority or Other
OG005 OG006	ANCOVA	0.1238	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-0.9	Standard Error of the Mean	0.6	2-Sided	95	-1.9	0.2	No	Superiority or Other
OG007 OG009	ANCOVA	<0.0001	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.6	Standard Error of the Mean	0.4	2-Sided	95	-2.4	-0.8	No	Superiority or Other
OG008 OG009	ANCOVA	0.0076	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.1	Standard Error of the Mean	0.4	2-Sided	95	-1.9	-0.3	No	Superiority or Other
OG010 OG012	ANCOVA	0.0049	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.2	Standard Error of the Mean	0.4	2-Sided	95	-2.1	-0.4	No	Superiority or Other
OG011 OG012	ANCOVA	0.0178	Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-1.0	Standard Error of the Mean	0.4	2-Sided	95	-1.9	-0.2	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-18.9± 2.0 OG001-23.9± 2.0 OG00213.3± 2.0 OG003-3.9± 2.0 OG004-16.7± 2.8 OG005-20.7± 2.8 OG00610.3± 2.8 OG007-16.7± 1.9 OG008-19.7± 1.9 OG0097.6± 2.0 OG010-18.4± 2.1 OG011-19.3± 2.1 OG0129.4± 2.1

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-32.3	Standard Error of the Mean	2.8	2-Sided	95	-37.8	-26.7	No	Superiority or Other
OG001 OG002	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-37.2	Standard Error of the Mean	2.8	2-Sided	95	-42.8	-31.7	No	Superiority or Other
OG002 OG003	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-17.3	Standard Error of the Mean	2.8	2-Sided	95	-22.9	-11.7	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-15.0	Standard Error of the Mean	2.9	2-Sided	95	-20.6	-9.4	No	Superiority or Other
OG001 OG003	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-19.9	Standard Error of the Mean	2.8	2-Sided	95	-25.5	-14.4	No	Superiority or Other
OG004 OG006	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-27.1	Standard Error of the Mean	4.0	2-Sided	95	-35.0	-19.2	No	Superiority or Other
OG005 OG006	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-31.0	Standard Error of the Mean	4.0	2-Sided	95	-38.9	-23.2	No	Superiority or Other
OG007 OG009	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-24.3	Standard Error of the Mean	2.7	2-Sided	95	-29.7	-18.9	No	Superiority or Other
OG008 OG009	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-27.3	Standard Error of the Mean	2.8	2-Sided	95	-32.7	-21.9	No	Superiority or Other
OG010 OG012	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-27.8	Standard Error of the Mean	2.9	2-Sided	95	-33.6	-22.0	No	Superiority or Other
OG011 OG012	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-28.7	Standard Error of the Mean	3.0	2-Sided	95	-34.5	-22.8	No	Superiority or Other

Title

Denominators

Categories

Title	Measurements
	OG000-17.2± 2.1 OG001-20.4± 2.1 OG00214.4± 2.1 OG003-1.8± 2.1 OG004-13.9± 2.9 OG005-18.0± 2.9 OG0069.4± 2.9 OG007-14.5± 2.0 OG008-20.9± 2.0 OG00910.5± 2.0 OG010-19.5± 2.2 OG011-20.4± 2.2 OG01211.4± 2.2

Group IDs	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG002	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-31.7	Standard Error of the Mean	2.9	2-Sided	95	-37.4	-25.9	No	Superiority or Other
OG001 OG002	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-34.9	Standard Error of the Mean	2.9	2-Sided	95	-40.7	-29.1	No	Superiority or Other
OG002 OG003	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-16.3	Standard Error of the Mean	3.0	2-Sided	95	-22.1	-10.5	No	Superiority or Other
OG000 OG003	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-15.4	Standard Error of the Mean	3.0	2-Sided	95	-21.2	-9.6	No	Superiority or Other
OG001 OG003	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-18.7	Standard Error of the Mean	3.0	2-Sided	95	-24.5	-12.8	No	Superiority or Other
OG004 OG006	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-23.3	Standard Error of the Mean	4.1	2-Sided	95	-31.4	-15.3	No	Superiority or Other
OG005 OG006	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-27.4	Standard Error of the Mean	4.1	2-Sided	95	-35.4	-19.4	No	Superiority or Other
OG007 OG009	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-25.1	Standard Error of the Mean	2.8	2-Sided	95	-30.5	-19.6	No	Superiority or Other
OG008 OG009	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-31.4	Standard Error of the Mean	2.8	2-Sided	95	-36.9	-25.9	No	Superiority or Other
OG010 OG012	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-31.0	Standard Error of the Mean	3.1	2-Sided	95	-37.0	-24.9	No	Superiority or Other
OG011 OG012	ANCOVA	<0.0001	Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.	Adjusted mean difference	-31.8	Standard Error of the Mean	3.1	2-Sided	95	-37.9	-25.7	No	Superiority or Other

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

ID	Term
C570240	empagliflozin
D000068900	Sitagliptin Phosphate

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines