A Phase 2 Multi-Center Study To Evaluate The Efficacy And... | NCT01712061

ID	Type	Description	Link
2012-003332-23	EudraCT Number

A Phase 2 Multi-Center Study To Evaluate The Efficacy And... | NCT01712061 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Arm 1 PF-04634817	Active Comparator		Drug: PF-04634817
Arm 2 Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
PF-04634817	Drug	Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function	Arm 1 PF-04634817

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12	The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.	Baseline and Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in UACR at Weeks 4, 8 and 16	The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.	Baseline, Weeks 4, 8 and 16
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16

Other Outcomes

Measure	Description	Time Frame
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16		Baseline, Weeks 1, 4, 8, 12 and 16
Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16		Baseline, Weeks 1, 4, 8, 12 and 16

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Medical Investigations, Inc.		Little Rock	Arkansas	72205	United States
North America Research Institute

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	PF-04634817 150 mg	Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
FG001	PF-04634817 200 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0004 subjects FG0019 subjects FG0025 subjects
Death		FG0000 subjects FG0010 subjects FG0021 subjects
Lost to Follow-up		FG0001 subjects FG0010 subjects FG0021 subjects
Did Not Meet Entrance Criteria		FG0004 subjects FG0016 subjects FG0023 subjects
Medication Error Without Associated AE		FG0000 subjects FG0011 subjects FG0020 subjects
Withdrawal by Subject		FG0001 subjects FG0017 subjects FG0021 subjects
Other		FG0000 subjects FG0013 subjects FG0020 subjects

Arm/Group Information

ID	Title	Description
BG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
BG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.
BG002	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, Customized

Number

participants

Title

Denominators

Categories

Less than (<) 18 years

Title	Measurements
	BG0000 BG0010 BG0020

18-44 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00036 BG0017 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

Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12

The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.

The Full Analysis Set (FAS) was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.

Posted

Mean

95% Confidence Interval

percent (%)

Baseline and Week 12

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants	OG000159 OG00151

Title

Denominators

Categories

Title	Measurements
	OG00013.27± 5.43(3.14 to 24.62) OG0015.02± 6.87(-7.90 to 18.70)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Bayesian ANCOVA with covariates for baseline UACR and systolic blood pressure (SBP).			Ratio of geometric mean changes	0.92			2-Sided	95	0.75	1.09				No	Superiority or Other

Secondary

Change From Baseline in UACR at Weeks 4, 8 and 16

The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.

The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.

Posted

Geometric Mean

Geometric Coefficient of Variation

mg/millimolar creatinine (mmolCr)

Baseline, Weeks 4, 8 and 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16

The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.

Posted

Geometric Mean

Geometric Coefficient of Variation

mg/mmolCr

Baseline, Weeks 4, 8, 12 and 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16

eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Baseline, Week 1, 4, 8, 12 and 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16

Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Baseline, Week 12, and Week 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16

Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.

Posted

Mean

Standard Deviation

milligrams per deciliter (mg/dL)

Baseline, Week 1, 4, 8, 12 and 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Secondary

Change From Baseline in Serum Cystatin C at Weeks 12 and 16

Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 12, and Week 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.

Posted

Mean

Standard Deviation

percent

Baseline, Weeks 4, 8, 12 and 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants

Secondary

Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12

The PK Concentration Analysis Set is defined as all participants in the FAS for whom a PK sample was obtained and analyzed; n=number of participants analyzed in respective arms for category.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12

ID	Title	Description
OG000	PF-04634817 150 mg	Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
OG001	PF-04634817 200 mg	Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16

The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.

Posted

Mean

Standard Deviation

millimeters of mercury (mm Hg)

Baseline, Weeks 1, 4, 8, 12 and 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16

The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.

Posted

Mean

Standard Deviation

beats per minute (bpm)

Baseline, Weeks 1, 4, 8, 12 and 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16

The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.

Posted

Mean

Standard Deviation

kilograms (kg)

Baseline, Weeks 1, 4, 8, 12 and 16

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).

The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.

Posted

Number

participants

Baseline up to Week 16 (follow-up visit)

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Other Pre-specified

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings

Criteria for potentially clinically important ECG values were defined as: PR interval >=300 milliseconds (msec) or >=25%/50% increase when baseline is >200 msec and ≥50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); QTc >=450 msec or >=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.

The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.

Posted

Number

participants

Baseline, Weeks 1, 4 and 12

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants

Other Pre-specified

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.

The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication.

Posted

Number

participants

Baseline up to 28 days after last study drug administration

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units

Other Pre-specified

Number of Participants With Increased Fasting Blood Glucose

Posted

Number

participants

Baseline up to Week 16 (follow-up visit)

ID	Title	Description
OG000	PF-04634817 200 mg/150 mg	Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
OG001	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PF-04634817 150 mg	Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.	6	30	11	30
EG001	PF-04634817 200 mg	Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.	11	140	40	140
EG002	Placebo	Participants were dosed orally with matching placebo tablets QD for 12 weeks.	5	56	15	56

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected140 at risk EG0020 affected56 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0011 affected140 at risk EG0020 affected56 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0011 affected140 at risk EG0020 affected56 at risk
Chest pain	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0012 affected140 at risk EG0020 affected56 at risk
Generalised oedema	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0011 affected140 at risk EG0020 affected56 at risk
Pyrexia	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0011 affected140 at risk EG0020 affected56 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0011 affected140 at risk EG0020 affected56 at risk
Cellulitis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0010 affected140 at risk EG0021 affected56 at risk
Localised infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0010 affected140 at risk EG0021 affected56 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0011 affected140 at risk EG0021 affected56 at risk
Septic shock	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected140 at risk EG0020 affected56 at risk
Viral infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0011 affected140 at risk EG0020 affected56 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected140 at risk EG0020 affected56 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected140 at risk EG0020 affected56 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected140 at risk EG0020 affected56 at risk
Cerebral infarction	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0011 affected140 at risk EG0020 affected56 at risk
Dizziness	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected140 at risk EG0020 affected56 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0012 affected140 at risk EG0020 affected56 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0010 affected140 at risk EG0021 affected56 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected140 at risk EG0020 affected56 at risk
Erythrodermic psoriasis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected30 at risk EG0010 affected140 at risk EG0020 affected56 at risk
Homicide	Social circumstances	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0010 affected140 at risk EG0021 affected56 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected30 at risk EG0011 affected140 at risk EG0020 affected56 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG00112 affected140 at risk EG0023 affected56 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0015 affected140 at risk EG0022 affected56 at risk
Oedema peripheral	General disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected30 at risk EG0018 affected140 at risk EG0024 affected56 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0016 affected140 at risk EG0023 affected56 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0015 affected140 at risk EG0022 affected56 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0011 affected140 at risk EG0020 affected56 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0011 affected140 at risk EG0021 affected56 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0012 affected140 at risk EG0021 affected56 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0012 affected140 at risk EG0021 affected56 at risk
Dizziness	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0014 affected140 at risk EG0021 affected56 at risk
Dysuria	Renal and urinary disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected30 at risk EG0010 affected140 at risk EG0021 affected56 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected30 at risk EG0016 affected140 at risk EG0023 affected56 at risk

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D011507	Proteinuria
D014555	Urination Disorders
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Title

Denominators

Categories

Baseline (n=157,50)

Title	Measurements
	OG000127.41± 96 OG001121.80± 88

Change From Baseline at Week 4 (n=148,46)

Title	Measurements
	OG0000.89± 66 OG0010.91± 88

Change From Baseline at Week 8 (n=134,43)

Title	Measurements
	OG0000.90± 62 OG0010.94± 57

Change From Baseline at Week 16 (n=126,37)

Title	Measurements
	OG0000.93± 72 OG0010.92± 56

Title

Denominators

Categories

Baseline (n=155,49)

Title	Measurements
	OG000185.42± 97 OG001176.31± 82

Change From Baseline at Week 4 (n=143,45)

Title	Measurements
	OG0000.93± 47 OG0010.92± 76

Change From Baseline at Week 8 (n=130,42)

Title	Measurements
	OG0000.92± 50 OG0010.94± 46

Change From Baseline at Week 12 (n=125,42)

Title	Measurements
	OG0000.92± 58 OG0010.92± 79

Change From Baseline at Week 16 (n=125,36)

Title	Measurements
	OG0000.95± 58 OG0010.92± 55

Title

Denominators

Categories

Baseline (n=159,51)

Title	Measurements
	OG00041.80± 12.18 OG00141.65± 13.46

Change From Baseline at Week 1 (n=157,50)

Title	Measurements
	OG000-0.77± 5.80 OG001-0.35± 5.28

Change From Baseline at Week 4 (n=157,51)

Title	Measurements
	OG000-1.07± 5.37 OG001-1.32± 5.12

Change From Baseline at Week 8 (n=147,47)

Title	Measurements
	OG000-1.60± 5.34 OG001-2.15± 6.83

Change From Baseline at Week 12 (n=136,45)

Title	Measurements
	OG000-1.14± 5.70 OG001-1.03± 5.75

Change From Baseline at Week 16 (n=134,44)

Title	Measurements
	OG000-2.14± 6.42 OG001-1.18± 5.58

Title

Denominators

Categories

Baseline (n=159,50)

Title	Measurements
	OG00045.28± 14.22 OG00145.36± 14.94

Change From Baseline at Week 12 (n=135,44)

Title	Measurements
	OG000-1.10± 6.30 OG001-0.70± 5.49

Change From Baseline at Week 16 (n=134,43)

Title	Measurements
	OG000-2.27± 6.77 OG001-0.91± 6.30

Title

Denominators

Categories

Baseline (n=159,51)

Title	Measurements
	OG0001.72± 0.51 OG0011.77± 0.51

Change From Baseline at Week 1 (n=158,50)

Title	Measurements
	OG0000.05± 0.22 OG0010.03± 0.17

Change From Baseline at Week 4 (n=157,51)

Title	Measurements
	OG0000.06± 0.21 OG0010.11± 0.30

Change From Baseline at Week 8 (n=147,47)

Title	Measurements
	OG0000.06± 0.21 OG0010.09± 0.24

Change From Baseline at Week 12 (n=137,45)

Title	Measurements
	OG0000.05± 0.24 OG0010.08± 0.20

Change From Baseline at Week 16 (n=134,44)

Title	Measurements
	OG0000.09± 0.30 OG0010.09± 0.29

Title

Denominators

Categories

Baseline (n=159,51)

Title	Measurements
	OG0001.54± 0.43 OG0011.52± 0.41

Change From Baseline at Week 12 (n=136,45)

Title	Measurements
	OG0000.03± 0.25 OG0010.03± 0.21

Change From Baseline at Week 16 (n=134,44)

Title	Measurements
	OG0000.05± 0.26 OG0010.06± 0.25

Title

Denominators

Categories

Baseline (n=159,51)

Title	Measurements
	OG0007.51± 1.22 OG0017.91± 1.42

Change From Baseline at Week 4 (n=157,51)

Title	Measurements
	OG0000.03± 0.46 OG001-0.04± 0.46

Change From Baseline at Week 8 (n=147,46)

Title	Measurements
	OG000-0.02± 0.64 OG001-0.08± 0.71

Change From Baseline at Week 12 (n=137,44)

Title	Measurements
	OG000-0.01± 0.76 OG001-0.06± 0.81

Change From Baseline at Week 16 (n=133,44)

Title	Measurements
	OG0000.04± 0.89 OG001-0.04± 1.13

Title

Denominators

Categories

Day 1: 1 Hour Post-Dose (n=29,124)

Title	Measurements
	OG000434.5± 65 OG001524.4± 83

Day 1: 2 Hours Post-Dose (n=30,139)

Title	Measurements
	OG000579.3± 37 OG001602.9± 52

Day 1: 4 Hours Post-Dose (n=29,137)

Title	Measurements
	OG000497.4± 38 OG001547.7± 46

Week 1: Pre-Dose (n=28,131)

Title	Measurements
	OG000294.4± 60 OG001231.2± 73

Week 1: 2 Hours Post-Dose (n=28,132)

Title	Measurements
	OG000884.8± 42 OG001865.0± 55

Week 4: Pre-Dose (n=25,126)

Title	Measurements
	OG000231.3± 51 OG001239.5± 87

Week 4: 2 Hours Post-Dose (n=24,122)

Title	Measurements
	OG000785.8± 45 OG001918± 55

Week 8: Pre-Dose (n=23,113)

Title	Measurements
	OG000310.2± 79 OG001245.2± 77

Week 8: 2 Hours Post-Dose (n=23,114)

Title	Measurements
	OG000730.0± 70 OG001895± 57

Week 12 (n=20,113)

Title	Measurements
	OG000320.1± 75 OG001252.3± 84

Title

Denominators

Categories

Supine SBP: Baseline (n=168,53)

Title	Measurements
	OG000140.4± 13.96 OG001139.9± 13.60

Supine SBP:Change From Baseline Week 1 (n=164,53)

Title	Measurements
	OG000-0.8± 12.75 OG001-1.6± 12.87

Supine SBP:Change From Baseline Week 4 (n=154,49)

Title	Measurements
	OG000-0.5± 15.43 OG001-1.6± 14.19

Supine SBP:Change From Baseline Week 8 (n=142,47)

Title	Measurements
	OG000-3.4± 12.94 OG001-1.1± 13.71

Supine SBP:Change From Baseline Week 12 (n=134,45)

Title	Measurements
	OG000-2.0± 13.28 OG001-1.3± 13.23

Supine SBP:Change From Baseline Week 16 (n=138,45)

Title	Measurements
	OG000-2.4± 15.14 OG001-0.3± 14.41

Supine DBP: Baseline (n=168,53)

Title	Measurements
	OG00075.9± 8.97 OG00177.1± 6.88

Supine DBP:Change From Baseline Week 1 (n=164,53)

Title	Measurements
	OG000-0.2± 6.94 OG001-2.7± 7.58

Supine DBP:Change From Baseline Week 4 (n=154,49)

Title	Measurements
	OG0000.1± 8.23 OG001-1.8± 7.47

Supine DBP:Change From Baseline Week 8 (n=142,47)

Title	Measurements
	OG000-1.9± 7.46 OG001-1.5± 7.05

Supine DBP:Change From Baseline Week 12 (n=134,45)

Title	Measurements
	OG000-0.9± 6.88 OG001-0.2± 6.69

Supine DBP:Change From Baseline Week 16 (n=138,45)

Title	Measurements
	OG000-1.7± 7.98 OG0010.9± 8.40

Title

Denominators

Categories

Baseline (n=168,53)

Title	Measurements
	OG00068.7± 9.74 OG00169.3± 9.30

Change From Baseline at Week 1 (n=164,53)

Title	Measurements
	OG0000.1± 5.86 OG001-0.7± 5.63

Change From Baseline at Week 4 (n=154,49)

Title	Measurements
	OG0000.3± 6.01 OG001-1.0± 6.63

Change From Baseline at Week 8 (n=142,47)

Title	Measurements
	OG0000.2± 6.54 OG0011.4± 6.77

Change From Baseline at Week 12 (n=134,45)

Title	Measurements
	OG0000.2± 7.03 OG0010.5± 7.33

Change From Baseline at Week 16 (n=138,45)

Title	Measurements
	OG0001.4± 8.22 OG001-0.1± 6.92

Title

Denominators

Categories

Baseline (n=167,53)

Title	Measurements
	OG00093.8± 23.97 OG00195.1± 25.95

Change From Baseline at Week 1 (n=163,53)

Title	Measurements
	OG0000.0± 1.03 OG0010.3± 1.42

Change From Baseline at Week 4 (n=153,49)

Title	Measurements
	OG000-0.0± 1.74 OG0010.4± 3.29

Change From Baseline at Week 8 (n=141,47)

Title	Measurements
	OG0000.1± 2.45 OG0010.7± 2.74

Change From Baseline at Week 12 (n=134,45)

Title	Measurements
	OG0000.3± 2.66 OG0010.7± 3.02

Change From Baseline at Week 16 (n=137,45)

Title	Measurements
	OG000-0.1± 2.79 OG0010.2± 3.37

Title

Denominators

Categories

Maximum PR Interval >=300 msec (n=164,55)

Title	Measurements
	OG0003 OG0010

Maximum QRS Complex >=140 msec (n=169,56)

Title	Measurements
	OG0002 OG0011

Maximum QT Interval >=500 msec (n=169,56)

Title	Measurements
	OG0000 OG0010

Maximum QTc Interval 450-<480 msec (n=169,56)

Title	Measurements
	OG00023 OG00111

Maximum QTc Interval 480-<500 msec (n=169,56)

Title	Measurements
	OG0004 OG0011

Maximum QTc Interval >=500 msec (n=169,56)

Title	Measurements
	OG0000 OG0010

Maximum QTcF Interval 450-<480 msec (n=169,56)

Title	Measurements
	OG00011 OG0015

Maximum QTcF Interval 480-<500 msec (n=169,56)

Title	Measurements
	OG0001 OG0011

Maximum QTcF Interval >=500 msec (n=169,56)

Title	Measurements
	OG0001 OG0010

PR Interval >=25/50% IFB (n=163,53)

Title	Measurements
	OG0003 OG0010

QRS Complex >=50% IFB (n=169,55)

Title	Measurements
	OG0003 OG0010

QTc Interval 30-<60 msec IFB (n=169,55)

Title	Measurements
	OG00015 OG0014

QTc Interval >=60 msec IFB (n=169,55)

Title	Measurements
	OG0000 OG0010

QTcF Interval 30-<60 msec IFB (n=169,55)

Title	Measurements
	OG0008 OG0013

QTcF Interval >=60 msec IFB (n=169,55)

Title	Measurements
	OG0001 OG0010

ID	Term
D003928	Diabetic Nephropathies
D003924	Diabetes Mellitus, Type 2
D000419	Albuminuria