HealthyPhase 1NCT02266472

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Male and Female

A Phase 1 study testing metformin, empagliflozin/metformin and empagliflozin 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 purpose of this trial is to investigate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions. 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?: metformin, empagliflozin/metformin and empagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteGermany
Study dates: Nov 2014to Dec 2014
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 male and female subjects
age of 18 to 55 years
body mass index (BMI) of 18.5 to 29.9 kg/m2
additional inclusion criteria may apply

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders
additional exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release (10 mg/1000 mg) Compared With the Free Combination of Empagliflozin and Metformin Extended Release Tablets in Healthy Subjects Following a High-fat, High-caloric Meal (an Open-label, Randomised, Single Dose, Crossover Trial)

Conditions: Healthy
Being tested: metformin, empagliflozin/metformin, empagliflozin

What participants receive

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

metforminDrug
single dose of metformin given as tablets
empagliflozin/metforminDrug
Single dose empagliflozin/metformin given as fixed-dose combination tablet
empagliflozinDrug
single dose of empagliflozin given as tablet

Study groups in NCT02266472
Study group	Role	What they receive
Fixed dose combination	Experimental	Single dose empagliflozin/metformin Receives: Drug: empagliflozin/metformin
Single tablets combination	Active comparator	single doses empagliflozin and metformin Receives: Drug: metformin; Drug: empagliflozin

What is being measured

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

AUC0-tz of Empagliflozin in Plasma
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
Measured: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
AUC0-tz of Metformin in Plasma
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
Measured: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
Cmax of Empagliflozin in Plasma
Maximum measured concentration of the empagliflozin in plasma
Measured: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
Cmax of Metformin in Plasma
Maximum measured concentration of the metformin in plasma
Measured: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration

Secondary outcomes (2)

AUC0-infinity of Empagliflozin in Plasma
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Measured: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
AUC0-infinity of Metformin in Plasma
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Measured: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration

Timeline

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

Nov 2014Dec 2014

First posted17 Oct 2014 (estimated)
Study startNov 2014
Primary completionDec 2014
Study completionDec 2014

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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02266472
Sponsor's protocol ID: 1276.28
Other IDs: 2014-002360-32, 2014
Status last verified: Jan 2017
First submitted: 16 Oct 2014
Last updated: 9 Mar 2017
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?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release (10 mg/1000 mg) Compared With the Free Combination of Empagliflozin and Metformin Extended Release Tablets in Healthy Subjects Following a High-fat, High-caloric Meal (an Open-label, Randomised, Single Dose, Crossover Trial)
ClinicalTrials.gov ID: NCT02266472
Acronym / sponsor ID: 1276.28
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Nov 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 17 Oct 2014 (estimated)
Results: Posted 9 Mar 2017

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: 2

Arm	Type	Receives
Fixed dose combination	Experimental	Drug: empagliflozin/metforminSingle dose empagliflozin/metformin
Single tablets combination	Active comparator	Drug: metformin, Drug: empagliflozinsingle doses empagliflozin and metformin

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy male and female subjects
age of 18 to 55 years
body mass index (BMI) of 18.5 to 29.9 kg/m2
additional inclusion criteria may apply

Key exclusion criteria (8 listed)

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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
metforminsingle dose of metformin given as tablets	Drug	Single tablets combination
empagliflozin/metforminSingle dose empagliflozin/metformin given as fixed-dose combination tablet	Drug	Fixed dose combination
empagliflozinsingle dose of empagliflozin given as tablet	Drug	Single tablets combination

Primary outcome

AUC0-tz of Empagliflozin in Plasma
Time frame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
AUC0-tz of Metformin in Plasma
Time frame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
Cmax of Empagliflozin in Plasma
Time frame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
Maximum measured concentration of the empagliflozin in plasma
Cmax of Metformin in Plasma
Time frame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
Maximum measured concentration of the metformin in plasma

2 secondary outcomes

AUC0-infinity of Empagliflozin in Plasma
Time frame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
AUC0-infinity of Metformin in Plasma
Time frame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration

Results and safety

Results posted to the registry on 9 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fed 10mg+1000mg Fixed Dose Combination (FDC)/Single (TR)	15	15
Fed 10mg+1000mg Single/FDC (RT)	15	15

Primary outcome: AUC0-tz of Empagliflozin in Plasma

Time frame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Fed 10mg+ 1000mg FDC (T) n = 30	Fed 10mg+1000mg Single (R) n = 30
Value	2190 (18.1)	2210 (16.3)

Fed 10mg+ 1000mg FDC (T) vs Fed 10mg+1000mg Single (R): ratio of the adjusted means: 99.11 (90% CI 96.40 to 101.89), p <0.0001, ANOVA

Population analysed: Pharmacokinetic set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.

Primary outcome: AUC0-tz of Metformin in Plasma

Measure	Fed 10mg+ 1000mg FDC (T) n = 29	Fed 10mg+1000mg Single (R) n = 30
Value	10800 (20.1)	10700 (22.4)

Fed 10mg+ 1000mg FDC (T) vs Fed 10mg+1000mg Single (R): ratio of the adjusted means: 101.25 (90% CI 96.54 to 106.19), p <0.0001, ANOVA

Population analysed: PKS

Primary outcome: Cmax of Empagliflozin in Plasma

Measure	Fed 10mg+ 1000mg FDC (T) n = 30	Fed 10mg+1000mg Single (R) n = 30
Value	243 (23.1)	245 (20.4)

Fed 10mg+ 1000mg FDC (T) vs Fed 10mg+1000mg Single (R): ratio of the adjusted means: 99.12 (90% CI 93.69 to 104.87), p <0.0001, ANOVA

Population analysed: PKS

Primary outcome: Cmax of Metformin in Plasma

Measure	Fed 10mg+ 1000mg FDC (T) n = 29	Fed 10mg+1000mg Single (R) n = 30
Value	1170 (25.5)	1080 (25.2)

Fed 10mg+ 1000mg FDC (T) vs Fed 10mg+1000mg Single (R): ratio of the adjusted means: 108.58 (90% CI 104.17 to 113.17), p <0.0001, ANOVA

Population analysed: PKS

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until the end-of-trial examination (Up to 14 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fed 10mg+1000mg Single (R)	0 of 30 (0%)	9 of 30 (30%)	Not reported
Fed 10mg+ 1000mg FDC (T)	0 of 30 (0%)	5 of 30 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 metformin, empagliflozin/metformin and empagliflozin 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 4 inclusion and 8 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 9 Mar 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 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 9 Mar 2017). 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?

AUC0-tz of Empagliflozin in Plasma (time frame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h 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 NCT02266472.

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 9 Mar 2017.