HealthyPhase 1NCT01195675

Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects

A Phase 1 study testing BI 10773 (low), Moxifloxacin and BI 10773 (high) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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 demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 10773 (low), Moxifloxacin and BI 10773 (high)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteGermany
Study dates: Aug 2010to Nov 2010
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

healthy female and male subjects

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

1245.16.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Assessment of the Effect of 25 mg and 200 mg of BI 10773 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Five-period Crossover Phase-I-study With Moxifloxacin as Positive Control

The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo

Conditions: Healthy
Being tested: BI 10773 (low), Moxifloxacin, BI 10773 Placebo, BI 10773 (high)

What participants receive

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

BI 10773 (low)Drug
single oral dose
MoxifloxacinDrug
single oral dose
BI 10773 PlaceboDrug
2 times single dose
BI 10773 (high)Drug
single oral dose

Study groups in NCT01195675
Study group	Role	What they receive
BI 10773	Experimental	single oral (high and low) dose per subject Receives: Drug: BI 10773 (low); Drug: BI 10773 (high)
Placebo	Placebo comparator	2 single oral doses per subject Receives: Drug: BI 10773 Placebo
Moxifloxacin	Active comparator	single oral dose per subject Receives: Drug: Moxifloxacin

What is being measured

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

Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing
Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg.
Note, the treatment means presented are actually adjusted means.
Measured: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose
Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing
Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg.
Note, the treatment means presented are actually adjusted means.
Measured: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose

Secondary outcomes (5)

Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing
Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 25 mg.
Note, presented means are actually adjusted means.
Measured: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose
Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing
Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 200 mg.
Note, presented means are actually adjusted means.
Measured: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose
Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing
Mean changes from baseline in QTcN from all ECGs taken between 2 hours and 4 hours after dosings
Note, the means presented are actually adjusted means.
Measured: 60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose
Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings
Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 25mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.
For this outcome results are presented for the 24 hour timepoint as this was when the maximum value was seen.
Note, the presented means are actually adjusted means.
Measured: 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose
Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings
Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 200mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.
For this outcome results are presented for the 2.5 hour timepoint as this was when the maximum value was seen.
Note, the presented means are actually adjusted means.
Measured: 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose

Timeline

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

Aug 2010Nov 2010

First posted6 Sep 2010 (estimated)
Study startAug 2010
Primary completionNov 2010

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 HealthyStudies 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: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01195675
Sponsor's protocol ID: 1245.16
Other IDs: 2010-018609-13
Status last verified: Jul 2014
First submitted: 3 Sep 2010
Last updated: 28 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Ring A, Brand T, Macha S, Breithaupt-Groegler K, Simons G, Walter B, Woerle HJ, Broedl UC. The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study. Cardiovasc Diabetol. 2013 Apr 24;12:70. doi: 10.1186/1475-2840-12-70.
PubMed 23617452

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 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Effect of 25 mg and 200 mg of BI 10773 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Five-period Crossover Phase-I-study With Moxifloxacin as Positive Control
ClinicalTrials.gov ID: NCT01195675
Acronym / sponsor ID: 1245.16
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Nov 2010 (actual)
First posted: 6 Sep 2010 (estimated)
Results: Posted 28 Jul 2014

Clinical summary

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

The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
BI 10773	Experimental	Drug: BI 10773 (low), Drug: BI 10773 (high)single oral (high and low) dose per subject
Placebo	Placebo comparator	Drug: BI 10773 Placebo2 single oral doses per subject
Moxifloxacin	Active comparator	Drug: Moxifloxacinsingle oral dose per subject

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

healthy female and male subjects

Key exclusion criteria (0 listed)

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
BI 10773 (low)single oral dose	Drug	BI 10773
Moxifloxacinsingle oral dose	Drug	Moxifloxacin
BI 10773 Placebo2 times single dose	Drug	Placebo
BI 10773 (high)single oral dose	Drug	BI 10773

Primary outcome

Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose
Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg. Note, the treatment means presented are actually adjusted means.
Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose
Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg. Note, the treatment means presented are actually adjusted means.

5 secondary outcomes

Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose
Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose
Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose
Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose
Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose

Results and safety

Results posted to the registry on 28 Jul 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
Study Overall	30	27

Primary outcome: Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing

Time frame: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose. Mean (Standard Error). Unit: ms

Measure	Placebo n = 29	Empa 25 mg n = 28
Value	3.68 (1.00)	4.27 (1.10)

Placebo vs Empa 25 mg: Mean Difference (Final Values): 0.59 (90% CI -0.69 to 1.87), ANCOVA

Population analysed: Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.

Primary outcome: Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing

Time frame: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose. Mean (Standard Deviation). Unit: ms

Measure	Placebo n = 29	Empa 200 mg n = 30
Value	3.67 (0.86)	3.44 (0.94)

Placebo vs Empa 200 mg: Mean Difference (Final Values): -0.22 (90% CI -1.39 to 0.94), ANCOVA

Population analysed: Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Drug administration until beginning of next sequence/end of trial, up to 48 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 29 (0%)	6 of 29 (20.7%)	Not reported
Empa 25 mg	0 of 28 (0%)	3 of 28 (10.7%)	Not reported
Empa 200 mg	0 of 30 (0%)	2 of 30 (6.7%)	Not reported
Moxifloxacin	1 of 29 (3.4%)	0 of 29 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23617452Ring A, Brand T, Macha S, Breithaupt-Groegler K, Simons G, Walter B, Woerle HJ, Broedl UC. The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study. Cardiovasc Diabetol. 2013 Apr 24;12:70. doi: 10.1186/1475-2840-12-70.
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

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 BI 10773 (low), Moxifloxacin and BI 10773 (high) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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 1 inclusion and 0 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 28 Jul 2014. 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 Germany. 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 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 28 Jul 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?

Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing (time frame: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose). The study lists 2 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 NCT01195675, 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 28 Jul 2014.