Diabetes Mellitus, Type 2Phase 2NCT00885118

4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

A Phase 2 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM. Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 5 sitesJapan
Study dates: Apr 2009to Oct 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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,

Show all 15Show fewer

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

1245.15.003 Boehringer Ingelheim Investigational Site
Hachioji, Tokyo
1245.15.002 Boehringer Ingelheim Investigational Site
Koganei, Tokyo
1245.15.001 Boehringer Ingelheim Investigational Site
Nakano-ku, Tokyo
1245.15.005 Boehringer Ingelheim Investigational Site
Suita, Osaka
1245.15.004 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo (middle dose), Placebo, BI 10773, Placebo (high dose), Placebo (low dose)
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo (middle dose)Drug
Placebo tablets once a day
PlaceboDrug
Placebo tablets once a day
BI 10773Drug
BI 10773 middle dose tablets once a day
BI 10773Drug
BI 10773 high dose tablets once a day
BI 10773Drug
BI 10773 middle dose tablets once a day
Placebo (high dose)Drug
Placebo tablets once a day
BI 10773Drug
BI 10773 low dose tablets once a day
Placebo (low dose)Drug
Placebo tablets once a day

Study groups in NCT00885118
Study group	Role	What they receive
BI 10773 low dose quaque die (QD)	Experimental	patient to receive a BI 10773 low dose tablet and a placebo tablet once daily Receives: 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 Receives: 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 Receives: Drug: BI 10773
BI 10773 high dose QD	Experimental	patient to receive a BI 10773 high dose tablet and a placebo tablet once daily Receives: Drug: BI 10773; Drug: Placebo (high dose)
Placebo	Placebo comparator	patient to receive two tablets of placebo once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Urine Glucose Excretion
Change from baseline in Urine glucose excretion to 28 days
Measured: baseline and 28 days
Change From Baseline in Fasting Plasma Glucose
Change from baseline in Fasting plasma glucose to 28 days
Measured: baseline and 28 days
Change From Baseline in 8-point Glucose
Change from baseline in 8-point glucose to 27 days
Measured: baseline and 27 days

Secondary outcomes (27)

Change From Baseline in HbA1c
Change from baseline in HbA1c to 28 days
Measured: baseline and 28 days
Change From Baseline in Fructosamine
Change from baseline in Fructosamine to 28 days
Measured: baseline and 28 days
Change From Baseline in 1,5-anhydroglucitol
Change from baseline in 1,5-anhydroglucitol to 28 days
Measured: baseline and 28 days
Change From Baseline in Fasting Insulin
Change from baseline in Fasting insulin to 28 days
Measured: baseline and 28 days
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
Measured: baseline and 28 days
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
Measured: baseline and 28 days
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
Measured: baseline and 28 days
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
Measured: 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
AUC0-tz
area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration
Measured: 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
AUC0-∞
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Measured: 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
Cmax
maximum measured concentration of the analyte in plasma
Measured: 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
t1/2
terminal half-life of the analyte in plasma
Measured: 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
CL/F
apparent clearance of the analyte in plasma after extravascular administration
Measured: 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
Vz/F
apparent volume of distribution during the terminal phase λz following an extravascular dose
Measured: 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
Ae0-24
amount of the analyte that is eliminated in urine over the time interval 0 to 24
Measured: 0-5, 5-12, 12-24 hour after first drug administration
fe0-24
fraction of the analyte excreted unchanged in urine from time interval 0 to 24
Measured: 0-5, 5-12, 12-24 hour after first drug administration
CLR,0-24
renal clearance of the analyte in plasma after extravascular administration - based on 0-24 hours data
Measured: 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
AUCτ,ss
area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state
Measured: 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
Cmax,ss
maximum measured concentration of the analyte in plasma at steady state
Measured: 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
t1/2,ss
terminal half-life of the analyte in plasma at steady state
Measured: 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
CL/F,ss
apparent clearance of the analyte in plasma after extravascular administration at steady state
Measured: 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
Vz/F,ss
apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state
Measured: 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
RA,Cmax
accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax
Measured: 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
RA,AUC
accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ
Measured: 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
Ae0-24,ss
amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24
Measured: 0-5, 5-12, 12-24 hour after last drug administration
fe0-24,ss
fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24
Measured: 0-5, 5-12, 12-24 hour after last drug administration
CLR,ss
renal clearance of the analyte at steady state determined over the dosing interval τ
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Oct 2009

First posted21 Apr 2009 (estimated)
Study startApr 2009
Primary completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00885118
Sponsor's protocol ID: 1245.15
Status last verified: Nov 2014
First submitted: 20 Apr 2009
Last updated: 25 Nov 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 35472672
Yasui A, Lee G, Hirase T, Kaneko T, Kaspers S, von Eynatten M, Okamura T. Empagliflozin Induces Transient Diuresis Without Changing Long-Term Overall Fluid Balance in Japanese Patients With Type 2 Diabetes. Diabetes Ther. 2018 Apr;9(2):863-871. doi: 10.1007/s13300-018-0385-5. Epub 2018 Feb 27.
PubMed 29488164
Kanada S, Koiwai K, Taniguchi A, Sarashina A, Seman L, Woerle HJ. Pharmacokinetics, pharmacodynamics, safety and tolerability of 4 weeks' treatment with empagliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Nov 27;4(6):613-7. doi: 10.1111/jdi.12110. Epub 2013 Jun 25.
PubMed 24843716
Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.
PubMed 23940010

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00885118
Acronym / sponsor ID: 1245.15
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Oct 2009 (actual)
First posted: 21 Apr 2009 (estimated)
Results: Posted 16 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 5

Arm	Type	Receives
BI 10773 low dose quaque die (QD)	Experimental	Drug: BI 10773, Drug: Placebo (low dose)patient to receive a BI 10773 low dose tablet and a placebo tablet once daily
BI 10773 mid-low dose QD	Experimental	Drug: Placebo (middle dose), Drug: BI 10773patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily
BI 10773 mid-high dose QD	Experimental	Drug: BI 10773patient to receive two tablets of BI 10773 middle dose once daily
BI 10773 high dose QD	Experimental	Drug: BI 10773, Drug: Placebo (high dose)patient to receive a BI 10773 high dose tablet and a placebo tablet once daily
Placebo	Placebo comparator	Drug: Placebopatient to receive two tablets of placebo once daily

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)
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.

Key exclusion criteria (15 listed)

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
Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo (middle dose)Placebo tablets once a day	Drug	BI 10773 mid-low dose QD
PlaceboPlacebo tablets once a day	Drug	Placebo
BI 10773BI 10773 middle dose tablets once a day	Drug	BI 10773 mid-high dose QD
BI 10773BI 10773 high dose tablets once a day	Drug	BI 10773 high dose QD
BI 10773BI 10773 middle dose tablets once a day	Drug	BI 10773 mid-low dose QD
Placebo (high dose)Placebo tablets once a day	Drug	BI 10773 high dose QD
BI 10773BI 10773 low dose tablets once a day	Drug	BI 10773 low dose quaque die (QD)
Placebo (low dose)Placebo tablets once a day	Drug	BI 10773 low dose quaque die (QD)

Primary outcome

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

27 secondary outcomes

Change From Baseline in HbA1c
Time frame: baseline and 28 days
Change From Baseline in Fructosamine
Time frame: baseline and 28 days
Change From Baseline in 1,5-anhydroglucitol
Time frame: baseline and 28 days
Change From Baseline in Fasting Insulin
Time frame: baseline and 28 days
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)
Time frame: baseline and 28 days
Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)
Time frame: baseline and 28 days
Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)
Time frame: baseline and 28 days
AUCτ,1
Time frame: 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
AUC0-tz
Time frame: 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
AUC0-∞
Time frame: 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
Cmax
Time frame: 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
t1/2
Time frame: 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
CL/F
Time frame: 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
Vz/F
Time frame: 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
Ae0-24
Time frame: 0-5, 5-12, 12-24 hour after first drug administration
fe0-24
Time frame: 0-5, 5-12, 12-24 hour after first drug administration
CLR,0-24
Time frame: 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
AUCτ,ss
Time frame: 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
Cmax,ss
Time frame: 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
t1/2,ss
Time frame: 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
CL/F,ss
Time frame: 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
Vz/F,ss
Time frame: 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
RA,Cmax
Time frame: 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
RA,AUC
Time frame: 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
Ae0-24,ss
Time frame: 0-5, 5-12, 12-24 hour after last drug administration
fe0-24,ss
Time frame: 0-5, 5-12, 12-24 hour after last drug administration
CLR,ss
Time frame: 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

Results and safety

Results posted to the registry on 16 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	21	20
Empa 1 mg	19	19
Empa 5 mg	21	20
Empa 10 mg	20	20
Empa 25 mg	19	18

Primary outcome: Change From Baseline in Urine Glucose Excretion

Time frame: baseline and 28 days. Least squares mean (Standard Error). Unit: mg

Measure	Placebo n = 20	Empa 1 mg n = 19	Empa 5 mg n = 20	Empa 10 mg n = 18	Empa 25 mg n = 17
Value	599.763 (4497.460)	43428.245 (4598.593)	81564.440 (4460.086)	89189.527 (4704.967)	86220.111 (4828.541)

Placebo vs Empa 1 mg: Mean Difference (Final Values): 42828.482 (95% CI 29936.586 to 55720.378), p <0.0001, ANCOVA
Placebo vs Empa 5 mg: Mean Difference (Final Values): 80964.677 (95% CI 68437.160 to 93492.194), p <0.0001, ANCOVA
Placebo vs Empa 10 mg: Mean Difference (Final Values): 88589.764 (95% CI 75583.738 to 101595.790), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS)

Primary outcome: Change From Baseline in Fasting Plasma Glucose

Time frame: baseline and 28 days. Least squares mean (Standard Error). Unit: mg/dL

Measure	Placebo n = 20	Empa 1 mg n = 19	Empa 5 mg n = 20	Empa 10 mg n = 18	Empa 25 mg n = 17
Value	-15.436 (2.860)	-28.116 (2.965)	-35.355 (2.865)	-41.643 (3.009)	-42.670 (3.089)

Placebo vs Empa 1 mg: Mean Difference (Final Values): -12.680 (95% CI -20.936 to -4.424), p = 0.0030, ANCOVA
Placebo vs Empa 5 mg: Mean Difference (Final Values): -19.920 (95% CI -27.919 to -11.921), p <0.0001, ANCOVA
Placebo vs Empa 10 mg: Mean Difference (Final Values): -26.208 (95% CI -34.490 to -17.925), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS)

Primary outcome: Change From Baseline in 8-point Glucose

Time frame: baseline and 27 days. Least squares mean (Standard Error). Unit: mg/dL

Measure	Placebo n = 20	Empa 1 mg n = 19	Empa 5 mg n = 20	Empa 10 mg n = 18	Empa 25 mg n = 17
Value	-17.381 (3.932)	-35.263 (4.121)	-39.867 (3.903)	-43.646 (4.113)	-45.721 (4.187)

Placebo vs Empa 1 mg: Mean Difference (Final Values): -17.883 (95% CI -29.529 to -6.236), p = 0.0030, ANCOVA
Placebo vs Empa 5 mg: Mean Difference (Final Values): -22.487 (95% CI -33.308 to -11.665), p <0.0001, ANCOVA
Placebo vs Empa 10 mg: Mean Difference (Final Values): -26.265 (95% CI -37.762 to -14.768), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS)

27 secondary outcomes are reported in the full results.

Adverse events

Time frame: Between the first drug administration and the end of the trial after the last drug administration, up to 28 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 21 (0%)	1 of 21 (4.8%)	Not reported
Empa 1 mg	1 of 19 (5.3%)	6 of 19 (31.6%)	Not reported
Empa 5 mg	0 of 21 (0%)	2 of 21 (9.5%)	Not reported
Empa 10 mg	0 of 20 (0%)	5 of 20 (25%)	Not reported
Empa 25 mg	0 of 19 (0%)	7 of 19 (36.8%)	Not reported

Limitations and caveats (from the sponsor): 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".

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35472672Tuttle 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.
Derived from this study: PubMed 29488164Yasui A, Lee G, Hirase T, Kaneko T, Kaspers S, von Eynatten M, Okamura T. Empagliflozin Induces Transient Diuresis Without Changing Long-Term Overall Fluid Balance in Japanese Patients With Type 2 Diabetes. Diabetes Ther. 2018 Apr;9(2):863-871. doi: 10.1007/s13300-018-0385-5. Epub 2018 Feb 27.
Derived from this study: PubMed 24843716Kanada S, Koiwai K, Taniguchi A, Sarashina A, Seman L, Woerle HJ. Pharmacokinetics, pharmacodynamics, safety and tolerability of 4 weeks' treatment with empagliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Nov 27;4(6):613-7. doi: 10.1111/jdi.12110. Epub 2013 Jun 25.
Derived from this study: PubMed 23940010Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Urine Glucose Excretion (time frame: baseline and 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00885118, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2014.