HealthyPhase 1NCT02577315

Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions

A Phase 1 study testing Empagliflozin and Metformin in people with Healthy, run by Boehringer Ingelheim at 1 site in Russia.

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 two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male and female volunteers under fed conditions Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Empagliflozin and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteRussia
Study dates: Sep 2015to Oct 2015
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects aged 18 to 45 years and BMI 18.50 to 24.99 kg/m2 by Quetelet
Signed informed consent prior to admission to the study
Subjects must be able to undergo all trial related requests and procedures and follow any trial related restrictions on concomitant medications, diet and life style
Subjects must be never-smokers or ex-smokers who stopped smoking prior to enrolment (Visit 1)
Male or female subjects using adequate contraception from at least 30 days before the first study drug administration and until 30 days after trial completion

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and any laboratory value outside the reference range
Positive results of blood tests for infections (HIV, Syphilis, Hepatitis B or C), urine drug screening test and alcohol breath test
Any evidence of a concomitant disease judged clinically relevant by the investigator and presence of cardiovascular, respiratory, nervous, endocrine, reproductive, hematopoietic, immune system disorders; gastrointestinal, hepatic, urinary tract, hepatobiliary disorder, mental disturbance
Surgery of the gastrointestinal tract that could interfere with kinetics of the study drugs (except appendectomy)
History of relevant orthostatic hypotension, fainting spells, or blackouts
Relevant chronic or aAcute infections/ acute diseases occurred within 4 weeks before inclusion into the study

Show all 22Show fewer

History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
Regular use of medicinal products less than 2 weeks before investigational drug administration
Intake of systemic inhibitors or inductors of microsomal hepatic enzymes in less than 30 days before investigational drug administration
Intake of drugs with a long half-life (¿24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
Use of drugs which might reasonably influence the results of the trial based on current knowledge within 14 days prior to drug administration or during the trial
Participation in another trial with investigational drug administration within 3 months prior to administration of trial medication
Alcohol intake = 10 units of alcohol per week (1 unit of alcohol equals one 50 ml single measure of distilled alcoholic beverages/spirits (ABV 40%), or 0.5 litre of beer (ABV 5%), or 200 ml glass or red wine (ABV 12%) or history of alcohol abuse, narcomania, or other drug abuse.
Drug abuse
Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Inability to comply with dietary regimen as per protocol and per protocol procedures
Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Intake of xanthine-containing drinks or foods and alcohol from 72 h before screening and second treatment period
Intake of drinks or foods containing grapefruits, Chinese grapefruits, Seville oranges for female subjects:
Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion
Breast feeding

Trial locations and contacts

1 site in 1 country.

Russia1 site

1276.27.001 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

About this study

Official title: An Open-label, Randomised, Single-dose, Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Two Fixed Dose Combination Tablets of Empagliflozin 12.5 mg and Metformin 500 mg Compared With the Free Combination of Empagliflozin 25 mg and Metformin 1000 mg Tablets Under Fed Conditions

Conditions: Healthy
Being tested: Empagliflozin, Metformin

What participants receive

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

EmpagliflozinDrug
Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin
MetforminDrug
Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin
EmpagliflozinDrug
Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin
MetforminDrug
Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin

Study groups in NCT02577315
Study group	Role	What they receive
Test - Empagliflozin/Metformin	Experimental	fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin, oral with 200 mL of water uder fed conditions Receives: Drug: Empagliflozin; Drug: Metformin
Reference - Empagliflozin + Metformin	Experimental	free combination of 1 tablet of 25 mg Empagliflozin and 1 tablet of 1000 mg of Metformin, oral with 200 mL of 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 Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Measured: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Measured: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)
Maximum measured concentration of the Empagliflozin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Measured: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Maximum Measured Concentration of the Metformin in Plasma (Cmax)
Maximum measured concentration of the Metformin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Measured: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

Secondary outcomes (2)

Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Measured: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Measured: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 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.

Sep 2015Oct 2015

First posted16 Oct 2015 (estimated)
Study startSep 2015
Primary completionOct 2015
Study completionOct 2015

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: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02577315
Sponsor's protocol ID: 1276.27
Status last verified: Oct 2016
First submitted: 8 Oct 2015
Last updated: 30 Nov 2016
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 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomised, Single-dose, Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Two Fixed Dose Combination Tablets of Empagliflozin 12.5 mg and Metformin 500 mg Compared With the Free Combination of Empagliflozin 25 mg and Metformin 1000 mg Tablets Under Fed Conditions
ClinicalTrials.gov ID: NCT02577315
Acronym / sponsor ID: 1276.27
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 16 Oct 2015 (estimated)
Results: Posted 30 Nov 2016

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
Test - Empagliflozin/Metformin	Experimental	Drug: Empagliflozin, Drug: Metforminfixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin, oral with 200 mL of water uder fed conditions
Reference - Empagliflozin + Metformin	Experimental	Drug: Empagliflozin, Drug: Metforminfree combination of 1 tablet of 25 mg Empagliflozin and 1 tablet of 1000 mg of Metformin, oral with 200 mL of water under fed conditions

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male and female subjects aged 18 to 45 years and BMI 18.50 to 24.99 kg/m2 by Quetelet
Signed informed consent prior to admission to the study
Subjects must be able to undergo all trial related requests and procedures and follow any trial related restrictions on concomitant medications, diet and life style
Subjects must be never-smokers or ex-smokers who stopped smoking prior to enrolment (Visit 1)
Male or female subjects using adequate contraception from at least 30 days before the first study drug administration and until 30 days after trial completion

Key exclusion criteria (22 listed)

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and any laboratory value outside the reference range
Positive results of blood tests for infections (HIV, Syphilis, Hepatitis B or C), urine drug screening test and alcohol breath test
Any evidence of a concomitant disease judged clinically relevant by the investigator and presence of cardiovascular, respiratory, nervous, endocrine, reproductive, hematopoietic, immune system disorders; gastrointestinal, hepatic, urinary tract, hepatobiliary disorder, mental disturbance
Surgery of the gastrointestinal tract that could interfere with kinetics of the study drugs (except appendectomy)
History of relevant orthostatic hypotension, fainting spells, or blackouts

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
EmpagliflozinTest Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin	Drug	Test - Empagliflozin/Metformin
MetforminTest Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin	Drug	Test - Empagliflozin/Metformin
EmpagliflozinReference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin	Drug	Reference - Empagliflozin + Metformin
MetforminReference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin	Drug	Reference - Empagliflozin + Metformin

Primary outcome

Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)
Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Maximum measured concentration of the Empagliflozin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Maximum Measured Concentration of the Metformin in Plasma (Cmax)
Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Maximum measured concentration of the Metformin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.

2 secondary outcomes

Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

Results and safety

Results posted to the registry on 30 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fixed Dose Combination (FDC) / Empagliflozin + Metformin	12	12
Empagliflozin + Metformin / Fixed Dose Combination (FDC)	13	12

Primary outcome: Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: nanomol (nmol)* hours (h) / Litre (L)

Measure	Empagliflozin / Metformin (FDC) n = 24	Empagliflozin + Metformin Free Combination n = 24
Value	6147 (5.4)	6141 (5.4)

Empagliflozin / Metformin (FDC) vs Empagliflozin + Metformin Free Combination: Ratio of geometric means: 100.10 (90% CI 97.466 to 102.804), ANOVA

Population analysed: Pharmacokinetic analysis set (PKS): all subjects from treated set (TS) who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Subject was included, even if he/she contributed only 1 PK value for one period.

Primary outcome: Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Measure	Empagliflozin / Metformin (FDC) n = 24	Empagliflozin + Metformin Free Combination n = 24
Value	11912 (13.6)	12472 (13.6)

Empagliflozin / Metformin (FDC) vs Empagliflozin + Metformin Free Combination: Ratio of geometric means: 95.51 (90% CI 89.29 to 102.16), ANOVA

Population analysed: Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.

Primary outcome: Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)

Measure	Empagliflozin / Metformin (FDC) n = 24	Empagliflozin + Metformin Free Combination n = 24
Value	660 (10.9)	642 (10.9)

Empagliflozin / Metformin (FDC) vs Empagliflozin + Metformin Free Combination: Ratio of geometric means: 102.71 (90% CI 97.309 to 108.413), ANOVA

Primary outcome: Maximum Measured Concentration of the Metformin in Plasma (Cmax)

Measure	Empagliflozin / Metformin (FDC) n = 24	Empagliflozin + Metformin Free Combination n = 24
Value	1452 (11.3)	1437 (11.3)

Empagliflozin / Metformin (FDC) vs Empagliflozin + Metformin Free Combination: Ratio of geometric means: 101.07 (90% CI 95.565 to 106.902), ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 14 days after the last drug administration, up to 27 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empagliflozin / Metformin (FDC)	0 of 24 (0%)	0 of 24 (0%)	Not reported
Empagliflozin + Metformin Free Combination	0 of 25 (0%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
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 and Metformin in people with Healthy, run by Boehringer Ingelheim at 1 site in Russia.

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 5 inclusion and 22 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 30 Nov 2016. 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 Russia. 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 30 Nov 2016). 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 Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 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 NCT02577315.

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 30 Nov 2016.