HealthyPhase 1NCT01811953

Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

A Phase 1 study testing Empagliflozin, Metformin and Empagliflozin/Metformin 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

Search all trials

Trial summary

Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Empagliflozin, Metformin and Empagliflozin/Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteGermany
Study dates: Mar 2013to May 2013
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy male and female subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1276.8.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Bioequivalence of Empagliflozin/Metformin Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed and Fasted Conditions (an Open-label, Randomised, Single-dose, Crossover Study)

Conditions: Healthy
Being tested: Empagliflozin, Metformin, Empagliflozin/Metformin

What participants receive

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

EmpagliflozinDrug
medium dose oral administration
MetforminDrug
oral administration
EmpagliflozinDrug
low dose of Empagliflozin oral administration
Empagliflozin/MetforminDrug
low dose of Empagliflozin
MetforminDrug
oral administration
Empagliflozin/MetforminDrug
medium dose of Empagliflozin oral administration
EmpagliflozinDrug
medium dose oral administration
MetforminDrug
oral administration
Empagliflozin/MetforminDrug
medium dose of Empagliflozin oral administration

Study groups in NCT01811953
Study group	Role	What they receive
1 Empagliflozin/Metformin (T)	Experimental	fixed-dose-combination tablet, oral with 240 ml water under fasted conditions Receives: Drug: Empagliflozin/Metformin
2 Empagliflozin/Metformin (T)	Experimental	fixed-dose-combination tablet, oral with 240 ml water under fed conditions Receives: Drug: Empagliflozin/Metformin
3 Empagliflozin + Metformin (R)	Experimental	tablets, oral with 240 ml water under fasted conditions Receives: Drug: Empagliflozin; Drug: Metformin
4 Empagliflozin + Metformin (R)	Experimental	tablets, oral with 240 ml water under fed conditions Receives: Drug: Empagliflozin; Drug: Metformin
5 Empagliflozin/Metformin (T)	Experimental	fixed-dose-combination tablet, oral with 240 ml water under fed conditions Receives: Drug: Empagliflozin/Metformin
6 Empagliflozin + Metformin (R)	Experimental	tablets, oral with 240 ml water under fed conditions Receives: Drug: Empagliflozin; Drug: Metformin

What is being measured

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

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin
AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin
Measured: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin
AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin
Measured: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin
Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin
Measured: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum Measured Concentration of the Analyte in Plasma, Metformin
Cmax: maximum measured concentration of the analyte in plasma for Metformin
Measured: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Secondary outcomes (2)

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin
AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Empagliflozin
Measured: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin
AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Metformin
Measured: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Timeline

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

Mar 2013May 2013

First posted15 Mar 2013 (estimated)
Study startMar 2013
Primary completionMay 2013
Study completionMay 2013

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.
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: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01811953
Sponsor's protocol ID: 1276.8
Other IDs: 2012-005156-42
Status last verified: Jun 2015
First submitted: 13 Mar 2013
Last updated: 27 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

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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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of Empagliflozin/Metformin Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed and Fasted Conditions (an Open-label, Randomised, Single-dose, Crossover Study)
ClinicalTrials.gov ID: NCT01811953
Acronym / sponsor ID: 1276.8
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 15 Mar 2013 (estimated)
Results: Posted 27 Jul 2015

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: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
1 Empagliflozin/Metformin (T)	Experimental	Drug: Empagliflozin/Metforminfixed-dose-combination tablet, oral with 240 ml water under fasted conditions
2 Empagliflozin/Metformin (T)	Experimental	Drug: Empagliflozin/Metforminfixed-dose-combination tablet, oral with 240 ml water under fed conditions
3 Empagliflozin + Metformin (R)	Experimental	Drug: Empagliflozin, Drug: Metformintablets, oral with 240 ml water under fasted conditions
4 Empagliflozin + Metformin (R)	Experimental	Drug: Empagliflozin, Drug: Metformintablets, oral with 240 ml water under fed conditions
5 Empagliflozin/Metformin (T)	Experimental	Drug: Empagliflozin/Metforminfixed-dose-combination tablet, oral with 240 ml water under fed conditions
6 Empagliflozin + Metformin (R)	Experimental	Drug: Empagliflozin, Drug: Metformintablets, oral with 240 ml water under fed conditions

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy male and female subjects

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions

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
Empagliflozinmedium dose oral administration	Drug	4 Empagliflozin + Metformin (R)
Metforminoral administration	Drug	4 Empagliflozin + Metformin (R)
Empagliflozinlow dose of Empagliflozin oral administration	Drug	6 Empagliflozin + Metformin (R)
Empagliflozin/Metforminlow dose of Empagliflozin	Drug	5 Empagliflozin/Metformin (T)
Metforminoral administration	Drug	6 Empagliflozin + Metformin (R)
Empagliflozin/Metforminmedium dose of Empagliflozin oral administration	Drug	2 Empagliflozin/Metformin (T)
Empagliflozinmedium dose oral administration	Drug	3 Empagliflozin + Metformin (R)
Metforminoral administration	Drug	3 Empagliflozin + Metformin (R)
Empagliflozin/Metforminmedium dose of Empagliflozin oral administration	Drug	1 Empagliflozin/Metformin (T)

Primary outcome

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin
Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin
Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin
Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin
Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin
Maximum Measured Concentration of the Analyte in Plasma, Metformin
Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax: maximum measured concentration of the analyte in plasma for Metformin

2 secondary outcomes

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin
Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin
Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Results and safety

Results posted to the registry on 27 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed	6	6
Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted	6	6
Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed	6	6
Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted	6	5
Low Dose Emp: Emp/Met / Emp+Met	12	11
Low Dose Emp: Emp+Met / Emp/Met	12	11

Primary outcome: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin

Time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	1 Empagliflozin/Metformin (T) n = 23	2 Empagliflozin/Metformin (T) n = 24	3 Empagliflozin + Metformin (R) n = 24	4 Empagliflozin + Metformin (R) n = 22	5 Empagliflozin/Metformin (T) n = 22	6 Empagliflozin + Metformin (R) n = 23
Value	2810 (19.3)	2580 (20.4)	2760 (20.0)	2570 (20.7)	988 (16.2)	927 (18.0)

1 Empagliflozin/Metformin (T) vs 3 Empagliflozin + Metformin (R): Geometric mean ratio: 102.55 (90% CI 99.531 to 105.653), p <0.0001, ANOVA
2 Empagliflozin/Metformin (T) vs 4 Empagliflozin + Metformin (R): Geometric mean ratio: 98.88 (90% CI 94.879 to 103.059), p <0.0001, ANOVA
5 Empagliflozin/Metformin (T) vs 6 Empagliflozin + Metformin (R): Geometric mean ratio: 106.00 (90% CI 102.728 to 109.386), p <0.0001, ANOVA

Population analysed: Pharmacokinetic set (PKS): included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.

Primary outcome: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin

Measure	1 Empagliflozin/Metformin (T) n = 23	2 Empagliflozin/Metformin (T) n = 24	3 Empagliflozin + Metformin (R) n = 24	4 Empagliflozin + Metformin (R) n = 22	5 Empagliflozin/Metformin (T) n = 21	6 Empagliflozin + Metformin (R) n = 23
Value	10400 (23.0)	9220 (26.4)	11000 (26.8)	9140 (22.9)	9080 (32.7)	9060 (26.7)

1 Empagliflozin/Metformin (T) vs 3 Empagliflozin + Metformin (R): Geometric mean ratio: 96.13 (90% CI 91.25 to 101.26), p <0.0001, ANOVA
2 Empagliflozin/Metformin (T) vs 4 Empagliflozin + Metformin (R): Geometric mean ratio: 99.34 (90% CI 92.56 to 106.62), p <0.0001, ANOVA
5 Empagliflozin/Metformin (T) vs 6 Empagliflozin + Metformin (R): Geometric mean difference: 100.81 (90% CI 95.74 to 106.14), p <0.0001, ANOVA

Population analysed: PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.

Primary outcome: Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin

Measure	1 Empagliflozin/Metformin (T) n = 23	2 Empagliflozin/Metformin (T) n = 24	3 Empagliflozin + Metformin (R) n = 24	4 Empagliflozin + Metformin (R) n = 22	5 Empagliflozin/Metformin (T) n = 22	6 Empagliflozin + Metformin (R) n = 23
Value	379 (23.7)	276 (24.8)	375 (27.3)	258 (28.5)	108 (16.9)	103 (14.5)

1 Empagliflozin/Metformin (T) vs 3 Empagliflozin + Metformin (R): Geometric mean ratio: 102.12 (90% CI 96.255 to 108.351), p <0.0001, ANOVA
2 Empagliflozin/Metformin (T) vs 4 Empagliflozin + Metformin (R): Geometric mean ratio: 106.52 (90% CI 95.863 to 118.353), p = 0.0082, ANOVA
5 Empagliflozin/Metformin (T) vs 6 Empagliflozin + Metformin (R): Geometric mean ratio: 104.352 (90% CI 99.152 to 110.224), p <0.0001, ANOVA

Primary outcome: Maximum Measured Concentration of the Analyte in Plasma, Metformin

Measure	1 Empagliflozin/Metformin (T) n = 23	2 Empagliflozin/Metformin (T) n = 24	3 Empagliflozin + Metformin (R) n = 24	4 Empagliflozin + Metformin (R) n = 22	5 Empagliflozin/Metformin (T) n = 21	6 Empagliflozin + Metformin (R) n = 23
Value	1580 (26.9)	1160 (17.8)	1680 (25.8)	1180 (21.2)	1180 (23.8)	1150 (24.8)

1 Empagliflozin/Metformin (T) vs 3 Empagliflozin + Metformin (R): Geometric mean ratio: 94.87 (90% CI 88.931 to 101.210), p = 0.0001, ANOVA
2 Empagliflozin/Metformin (T) vs 4 Empagliflozin + Metformin (R): Geometric mean ratio: 97.97 (90% CI 92.339 to 103.935), p <0.0001, ANOVA
5 Empagliflozin/Metformin (T) vs 6 Empagliflozin + Metformin (R): Geometric mean ratio: 102.95 (90% CI 97.166 to 109.082), p <0.0001, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first trial medication intake until next intake or the end-of-trial visit, 10 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Empagliflozin/Metformin (T)	0 of 23 (0%)	6 of 23 (26.1%)	Not reported
2 Empagliflozin/Metformin (T)	0 of 24 (0%)	6 of 24 (25%)	Not reported
3 Empagliflozin + Metformin (R)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
4 Empagliflozin + Metformin (R)	0 of 24 (0%)	6 of 24 (25%)	Not reported
5 Empagliflozin/Metformin (T)	0 of 23 (0%)	9 of 23 (39.1%)	Not reported
6 Empagliflozin + Metformin (R)	0 of 23 (0%)	10 of 23 (43.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Empagliflozin, Metformin and Empagliflozin/Metformin 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 1 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 27 Jul 2015. 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. 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 27 Jul 2015). 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?

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin (time frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration). The study lists 4 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 NCT01811953.

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 27 Jul 2015.