Diabetes Mellitus, Type 2Phase 1NCT01581658

Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes

A Phase 1 study testing BI10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site 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 study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI10773
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteJapan
Study dates: 1 Apr 2012to 1 Nov 2012
Phase: Phase 1
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes patients
Glycosylated haemoglobin>= 6.1% (Japan Diabetes Society)
Estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of >= 15 mL/min/1.73m2

Who cannot join

Any evidence of significant disease (other than renal impairment)
Moderate and severe concurrent liver function impairment
Gastrointestinal tract surgery, that might affect absorption and elimination of drugs
Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
Chronic or relevant acute infections
Participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial

Trial locations and contacts

1 site in 1 country.

Japan1 site

1245.53.001 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka

Other trials in Japan

About this study

Official title: A Phase I, Open-label, Parallel-group Study to Investigate Pharmacokinetics, Pharmacodynamics and Safety of a Single 25 mg Dose of Empagliflozin in Japanese Type 2 Diabetes Patients With Different Degrees of Renal Impairment in Comparison to Type 2 Diabetes Patients With Normal Renal Function

Conditions: Diabetes Mellitus, Type 2
Being tested: BI10773
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.

BI10773Drug
BI10773 medium dose tablet single dose
BI10773Drug
BI10773 medium dose tablet single dose
BI10773Drug
BI10773 medium dose tablet single dose
BI10773Drug
BI10773 medium dose tablet single dose

Study groups in NCT01581658
Study group	Role	What they receive
BI10773 medium dose group 1	Experimental	BI10773 medium dose tablet single dose group 1 Receives: Drug: BI10773
BI10773 medium dose group 2	Experimental	BI10773 medium dose tablet single dose group 2 Receives: Drug: BI10773
BI10773 Medium dose group 3	Experimental	BI10773 medium dose tablet single dose group 3 Receives: Drug: BI10773
BI10773 Medium dose group 4	Experimental	BI10773 medium dose tablet single dose group 4 Receives: Drug: BI10773

What is being measured

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

Change From Baseline in Total Urinary Glucose Excretion (UGE)
change from baseline in total urinary glucose excretion (UGE) to 24 hours
Measured: baseline and 24 hours
Area Under the Concentration Time Curve of the Analyte in Plasma
Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity
Measured: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
Maximum Concentration
Maximum concentration of the analyte in plasma
Measured: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration

Timeline

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

1 Apr 20121 Nov 2012

First posted20 Apr 2012 (estimated)
Study start1 Apr 2012
Primary completion1 Nov 2012
Study completion1 Nov 2012

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 (1)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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01581658
Sponsor's protocol ID: 1245.53
Status last verified: Jul 2017
First submitted: 17 Apr 2012
Last updated: 14 Aug 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Sarashina A, Ueki K, Sasaki T, Tanaka Y, Koiwai K, Sakamoto W, Woerle HJ, Salsali A, Broedl UC, Macha S. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus. Clin Ther. 2014 Nov 1;36(11):1606-15. doi: 10.1016/j.clinthera.2014.08.001. Epub 2014 Sep 5.
PubMed 25199997

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label, Parallel-group Study to Investigate Pharmacokinetics, Pharmacodynamics and Safety of a Single 25 mg Dose of Empagliflozin in Japanese Type 2 Diabetes Patients With Different Degrees of Renal Impairment in Comparison to Type 2 Diabetes Patients With Normal Renal Function
ClinicalTrials.gov ID: NCT01581658
Acronym / sponsor ID: 1245.53
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 1 Apr 2012 (actual)
Primary completion: 1 Nov 2012 (actual)
Study completion: 1 Nov 2012 (actual)
First posted: 20 Apr 2012 (estimated)
Results: Posted 17 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
BI10773 medium dose group 1	Experimental	Drug: BI10773BI10773 medium dose tablet single dose group 1
BI10773 medium dose group 2	Experimental	Drug: BI10773BI10773 medium dose tablet single dose group 2
BI10773 Medium dose group 3	Experimental	Drug: BI10773BI10773 medium dose tablet single dose group 3
BI10773 Medium dose group 4	Experimental	Drug: BI10773BI10773 medium dose tablet single dose group 4

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Type 2 diabetes patients
Glycosylated haemoglobin>= 6.1% (Japan Diabetes Society)
Estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of >= 15 mL/min/1.73m2

Key exclusion criteria (6 listed)

Any evidence of significant disease (other than renal impairment)
Moderate and severe concurrent liver function impairment
Gastrointestinal tract surgery, that might affect absorption and elimination of drugs
Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
Chronic or relevant acute infections

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
BI10773BI10773 medium dose tablet single dose	Drug	BI10773 medium dose group 2
BI10773BI10773 medium dose tablet single dose	Drug	BI10773 Medium dose group 4
BI10773BI10773 medium dose tablet single dose	Drug	BI10773 medium dose group 1
BI10773BI10773 medium dose tablet single dose	Drug	BI10773 Medium dose group 3

Primary outcome

Change From Baseline in Total Urinary Glucose Excretion (UGE)
Time frame: baseline and 24 hours
change from baseline in total urinary glucose excretion (UGE) to 24 hours
Area Under the Concentration Time Curve of the Analyte in Plasma
Time frame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity
Maximum Concentration
Time frame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
Maximum concentration of the analyte in plasma

Results and safety

Results posted to the registry on 17 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
Normal Renal Function	8	8
Mild Renal Impairment	8	8
Moderate Renal Impairment	8	8
Severe Renal Impairment	8	8

Primary outcome: Change From Baseline in Total Urinary Glucose Excretion (UGE)

Time frame: baseline and 24 hours. Least squares mean (95% Confidence Interval). Unit: mg

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 6	Moderate Renal Impairment n = 8	Severe Renal Impairment n = 7
Value	74969.3 (4840.68)	62577.4 (5751.25)	57889.0 (4861.26)	23725.1 (5235.06)

Population analysed: Treated patients who had complete urine sample (baseline and 24 hours) for analyses.

Primary outcome: Area Under the Concentration Time Curve of the Analyte in Plasma

Time frame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 8	Severe Renal Impairment n = 8
Value	7480 (16.2)	9630 (15.9)	10800 (9.55)	11400 (40.4)

Normal Renal Function vs Mild Renal Impairment: Geometric mean ratio: 128.82 (90% CI 105.962 to 156.604), ANOVA
Normal Renal Function vs Moderate Renal Impairment: Geometric mean ratio: 143.82 (90% CI 118.306 to 174.848), ANOVA
Normal Renal Function vs Severe Renal Impairment: Geometric mean ratio: 152.31 (90% CI 125.287 to 185.166), ANOVA

Population analysed: Treated patients

Primary outcome: Maximum Concentration

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 8	Severe Renal Impairment n = 8
Value	1050 (19.1)	984 (30.8)	971 (26.2)	990 (43.8)

Normal Renal Function vs Mild Renal Impairment: Geometric mean ratio: 93.50 (90% CI 72.236 to 121.015), ANOVA
Normal Renal Function vs Moderate Renal Impairment: Geometric mean ratio: 92.18 (90% CI 71.216 to 119.305), ANOVA
Normal Renal Function vs Severe Renal Impairment: Geometric mean ratio: 94.01 (90% CI 72.630 to 121.674), ANOVA

Population analysed: Treated patients

Adverse events

Time frame: From trial drug intake until the end-of-study examination visit, up to 12 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Renal Function	0 of 8 (0%)	0 of 8 (0%)	Not reported
Mild Renal Impairment	0 of 8 (0%)	0 of 8 (0%)	Not reported
Moderate Renal Impairment	0 of 8 (0%)	2 of 8 (25%)	Not reported
Severe Renal Impairment	0 of 8 (0%)	0 of 8 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25199997Sarashina A, Ueki K, Sasaki T, Tanaka Y, Koiwai K, Sakamoto W, Woerle HJ, Salsali A, Broedl UC, Macha S. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus. Clin Ther. 2014 Nov 1;36(11):1606-15. doi: 10.1016/j.clinthera.2014.08.001. Epub 2014 Sep 5.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site 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 3 inclusion and 6 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 17 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 Total Urinary Glucose Excretion (UGE) (time frame: baseline and 24 hours). 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 NCT01581658, which also lists 1 linked publication.

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 14 Aug 2017.