4 Weeks Treatment With Empagliflozin (BI 10773) in Japane... | NCT00885118

NCT00885118

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI 10773 low dose quaque die (QD)	Experimental	patient to receive a BI 10773 low dose tablet and a placebo tablet once daily	Drug: BI 10773 Drug: Placebo (low dose)
BI 10773 mid-low dose QD	Experimental	patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily	Drug: Placebo (middle dose) Drug: BI 10773
BI 10773 mid-high dose QD	Experimental	patient to receive two tablets of BI 10773 middle dose once daily	Drug: BI 10773
BI 10773 high dose QD	Experimental	patient to receive a BI 10773 high dose tablet and a placebo tablet once daily	Drug: BI 10773 Drug: Placebo (high dose)
Placebo	Placebo Comparator	patient to receive two tablets of placebo once daily	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Placebo (middle dose)	Drug	Placebo tablets once a day	BI 10773 mid-low dose QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Urine Glucose Excretion	Change from baseline in Urine glucose excretion to 28 days	baseline and 28 days
Change From Baseline in Fasting Plasma Glucose	Change from baseline in Fasting plasma glucose to 28 days	baseline and 28 days
Change From Baseline in 8-point Glucose	Change from baseline in 8-point glucose to 27 days	baseline and 27 days

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c	Change from baseline in HbA1c to 28 days	baseline and 28 days
Change From Baseline in Fructosamine	Change from baseline in Fructosamine to 28 days

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
Hemoglobin A1c (HbA1c) at screening (Visit 1)
- For patients treated with 1 other oral antidiabetic drug: HbA1c between 6.5% and 9.0%.
- For patients not treated with any antidiabetic drug: HbA1c between 7.0% and 10.0%.
Age between 20 and 70 years
Body mass index (BMI) between18.0 and 40.0 kg/m2
Signed and dated written informed consent before admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria:

Antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent
Fasted blood glucose of >240 mg/dL (>13.3 mmol/L) or a randomly determined blood glucose level of >400 mg/dL (22.2 mmol/L) on 2 consecutive days during wash-out period.
Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and medically treated hypertension before the first administration such as
- Renal insufficiency (calculated estimated glomerular filtration rate <60)
- Cardiac insufficiency of New York Heart Association (NYHA) II-IV or other known cardiovascular diseases including hypertension of >160/95 mmHg,
- Neurological disorders (such as epilepsy) or psychiatric disorders
- Acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
- Any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder
Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:
- Statins.
- Antihypertensives (diuretics not allowed)
- alpha-Blockers for benign prostate hypertrophy
- Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
Additional inclusion/exclusion criteria apply

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1245.15.003 Boehringer Ingelheim Investigational Site		Hachioji, Tokyo			Japan
1245.15.002 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.
29488164

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo	Treatment with placebo once daily
FG001	Empa 1 mg	Treatment with Empa 1 mg once daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo	Treatment with placebo once daily
BG001	Empa 1 mg	Treatment with Empa 1 mg once daily
BG002	Empa 5 mg	Treatment with Empa 5 mg once daily
BG003	Empa 10 mg	Treatment with Empa 10 mg once daily
BG004	Empa 25 mg	Treatment with Empa 25 mg once daily
BG005	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
	OG000599.763± 4497.460 OG00143428.245± 4598.593 OG00281564.440± 4460.086 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 OG001	Difference calculated as empa 1mg minus placebo	ANCOVA	The baseline value was included as a continuous covariate.	<0.0001		Mean Difference (Final Values)	42828.482	Standard Error of the Mean	6487.174	2-Sided	95	29936.586	55720.378				No	Superiority or Other
OG000

Primary

Change From Baseline in Fasting Plasma Glucose

Change from baseline in Fasting plasma glucose to 28 days

Full analysis set (FAS)

Posted

Least Squares Mean

Standard Error

mg/dL

baseline and 28 days

ID	Title	Description
OG000	Placebo	Treatment with placebo once daily
OG001	Empa 1 mg	Treatment with Empa 1 mg once daily
OG002	Empa 5 mg	Treatment with Empa 5 mg once daily
OG003	Empa 10 mg	Treatment with Empa 10 mg once daily
OG004	Empa 25 mg	Treatment with Empa 25 mg once daily

Primary

Change From Baseline in 8-point Glucose

Change from baseline in 8-point glucose to 27 days

Full analysis set (FAS)

Posted

Least Squares Mean

Standard Error

mg/dL

baseline and 27 days

ID	Title	Description
OG000	Placebo	Treatment with placebo once daily
OG001	Empa 1 mg	Treatment with Empa 1 mg once daily
OG002	Empa 5 mg	Treatment with Empa 5 mg once daily
OG003	Empa 10 mg	Treatment with Empa 10 mg once daily
OG004	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Change From Baseline in HbA1c

Change from baseline in HbA1c to 28 days

Full analysis set (FAS)

Posted

Least Squares Mean

Standard Error

percentage of HbA1c

baseline and 28 days

ID	Title	Description
OG000	Placebo	Treatment with placebo once daily
OG001	Empa 1 mg	Treatment with Empa 1 mg once daily
OG002	Empa 5 mg	Treatment with Empa 5 mg once daily
OG003	Empa 10 mg	Treatment with Empa 10 mg once daily
OG004	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Change From Baseline in Fructosamine

Change from baseline in Fructosamine to 28 days

Full analysis set (FAS)

Posted

Least Squares Mean

Standard Error

umol/L

baseline and 28 days

ID	Title	Description
OG000	Placebo	Treatment with placebo once daily
OG001	Empa 1 mg	Treatment with Empa 1 mg once daily
OG002	Empa 5 mg	Treatment with Empa 5 mg once daily
OG003	Empa 10 mg	Treatment with Empa 10 mg once daily
OG004	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Change From Baseline in 1,5-anhydroglucitol

Change from baseline in 1,5-anhydroglucitol to 28 days

Full analysis set (FAS)

Posted

Least Squares Mean

Standard Error

ug/mL

baseline and 28 days

ID	Title	Description
OG000	Placebo	Treatment with placebo once daily
OG001	Empa 1 mg	Treatment with Empa 1 mg once daily
OG002	Empa 5 mg	Treatment with Empa 5 mg once daily
OG003	Empa 10 mg	Treatment with Empa 10 mg once daily
OG004	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Change From Baseline in Fasting Insulin

Change from baseline in Fasting insulin to 28 days

Full analysis set (FAS)

Posted

Least Squares Mean

Standard Error

uU/mL

baseline and 28 days

ID	Title	Description
OG000	Placebo	Treatment with placebo once daily
OG001	Empa 1 mg	Treatment with Empa 1 mg once daily
OG002	Empa 5 mg	Treatment with Empa 5 mg once daily
OG003	Empa 10 mg	Treatment with Empa 10 mg once daily
OG004	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)

Change from baseline in the area under the curve of plasma glucose levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days

Full analysis set (FAS)

Posted

Least Squares Mean

Standard Error

hr*mg/dL

baseline and 28 days

ID	Title	Description
OG000	Placebo	Treatment with placebo once daily
OG001	Empa 1 mg	Treatment with Empa 1 mg once daily
OG002	Empa 5 mg	Treatment with Empa 5 mg once daily
OG003	Empa 10 mg	Treatment with Empa 10 mg once daily
OG004	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)

Change from baseline in the area under the curve of glucagon levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days

Full analysis set (FAS)

Posted

Least Squares Mean

Standard Error

hr*pg/mL

baseline and 28 days

ID	Title	Description
OG000	Placebo	Treatment with placebo once daily
OG001	Empa 1 mg	Treatment with Empa 1 mg once daily
OG002	Empa 5 mg	Treatment with Empa 5 mg once daily
OG003	Empa 10 mg	Treatment with Empa 10 mg once daily
OG004	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)

Change from baseline in the area under the curve of insulin levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days

Full analysis set (FAS)

Posted

Least Squares Mean

Standard Error

hr*uU/mL

baseline and 28 days

ID	Title	Description
OG000	Placebo	Treatment with placebo once daily
OG001	Empa 1 mg	Treatment with Empa 1 mg once daily
OG002	Empa 5 mg	Treatment with Empa 5 mg once daily
OG003	Empa 10 mg	Treatment with Empa 10 mg once daily
OG004	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

AUCτ,1

Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol*h/L

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

AUC0-tz

area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol*h/L

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

AUC0-∞

area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol*h/L

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Cmax

maximum measured concentration of the analyte in plasma

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol/L

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units	Counts

Secondary

t1/2

terminal half-life of the analyte in plasma

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

hour

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units	Counts

Secondary

CL/F

apparent clearance of the analyte in plasma after extravascular administration

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/min

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units	Counts

Secondary

Vz/F

apparent volume of distribution during the terminal phase λz following an extravascular dose

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units

Secondary

Ae0-24

amount of the analyte that is eliminated in urine over the time interval 0 to 24

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol

0-5, 5-12, 12-24 hour after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units	Counts
Participants

Secondary

fe0-24

fraction of the analyte excreted unchanged in urine from time interval 0 to 24

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

percentage of Ae0-24 (to dosage)

0-5, 5-12, 12-24 hour after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units	Counts

Secondary

CLR,0-24

renal clearance of the analyte in plasma after extravascular administration - based on 0-24 hours data

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/min

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

AUCτ,ss

area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol*h/L

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Cmax,ss

maximum measured concentration of the analyte in plasma at steady state

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol/L

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units

Secondary

t1/2,ss

terminal half-life of the analyte in plasma at steady state

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

hour

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units	Counts

Secondary

CL/F,ss

apparent clearance of the analyte in plasma after extravascular administration at steady state

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/min

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Vz/F,ss

apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

RA,Cmax

accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

RA,AUC

accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Secondary

Ae0-24,ss

amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol

0-5, 5-12, 12-24 hour after last drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units	Counts

Secondary

fe0-24,ss

fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

percentage of Ae0-24 (to dosage)

0-5, 5-12, 12-24 hour after last drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units	Counts

Secondary

CLR,ss

renal clearance of the analyte at steady state determined over the dosing interval τ

Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/min

Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration

ID	Title	Description
OG000	Empa 1 mg	Treatment with Empa 1 mg once daily
OG001	Empa 5 mg	Treatment with Empa 5 mg once daily
OG002	Empa 10 mg	Treatment with Empa 10 mg once daily
OG003	Empa 25 mg	Treatment with Empa 25 mg once daily

Units

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Treatment with placebo once daily	0	21	1	21
EG001	Empa 1 mg	Treatment with Empa 1 mg once daily	1	19	6	19
EG002	Empa 5 mg	Treatment with Empa 5 mg once daily	0	21	2	21
EG003	Empa 10 mg	Treatment with Empa 10 mg once daily	0	20	5	20
EG004	Empa 25 mg	Treatment with Empa 25 mg once daily	0	19	7	19

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Transient ischaemic attack	Nervous system disorders	MEDDRA 12.1	Systematic Assessment		EG0000 affected21 at risk EG0011 affected19 at risk EG0020 affected21 at risk EG0030 affected20 at risk EG0040 affected19 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0012 affected19 at risk EG0021 affected21 at risk EG0030 affected20 at risk EG0041 affected19 at risk
Cystitis	Infections and infestations	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected19 at risk EG0020 affected21 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MEDDRA 12.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected19 at risk EG0020 affected21 at risk EG003
Dry eye	Eye disorders	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected19 at risk EG0020 affected21 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected19 at risk EG0020 affected21 at risk EG003
Constipation	Gastrointestinal disorders	MEDDRA 12.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected19 at risk EG0021 affected21 at risk EG003
Diarrhoea	Gastrointestinal disorders	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected19 at risk EG0020 affected21 at risk EG003
Toothache	Gastrointestinal disorders	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected19 at risk EG0020 affected21 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected19 at risk EG0020 affected21 at risk EG003
Pollakiuria	Renal and urinary disorders	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected19 at risk EG0020 affected21 at risk EG003
Oedema peripheral	General disorders	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected19 at risk EG0020 affected21 at risk EG003
Alpha 1 microglobulin urine increased	Investigations	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected19 at risk EG0020 affected21 at risk EG003
Beta 2 microglobulin urine increased	Investigations	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected19 at risk EG0020 affected21 at risk EG003
Contusion	Injury, poisoning and procedural complications	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected19 at risk EG0020 affected21 at risk EG003
Fall	Injury, poisoning and procedural complications	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected19 at risk EG0020 affected21 at risk EG003
Heat illness	Injury, poisoning and procedural complications	MEDDRA 12.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected19 at risk EG0020 affected21 at risk EG003

Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".

Certain Agreements

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
C570240	empagliflozin

OG00486220.111± 4828.541

Units	Counts
Participants	OG00019 OG00119 OG00218 OG00317

Units	Counts
Participants	OG00019 OG00119 OG00218 OG00317

EG0041 affected19 at risk

EG0040 affected19 at risk

EG0041 affected19 at risk

EG0040 affected19 at risk

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