Diabetes Mellitus, Type 2Phase 1NCT01211197

Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability

A Phase 1 study testing C: BI 10773 / metformin tablet, B: BI 10773 tablet and metformin tablet and A: BI 10773 / metformin tablet in people with Diabetes Mellitus, Type 2, 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 the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: C: BI 10773 / metformin tablet, B: BI 10773 tablet and metformin tablet and A: BI 10773 / metformin tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteGermany
Study dates: Oct 2010to Dec 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 males and females according to the following criteria
Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

Who cannot join

Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease

Trial locations and contacts

1 site in 1 country.

Germany1 site

1276.5.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Relative Bioavailability of a 12.5 mg BI 10773 / 1000 mg Metformin Fixed Dose Combination Tablet Compared With Its Monocomponents and Administered With and Without Food (an Open-label, Randomised, Single-dose, Three-way Crossover, Phase I Trial in Healthy Volunteers)

Conditions: Diabetes Mellitus, Type 2
Being tested: C: BI 10773 / metformin tablet, B: BI 10773 tablet and metformin tablet, A: BI 10773 / metformin tablet
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.

C: BI 10773 / metformin tabletDrug
BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal
B: BI 10773 tablet and metformin tabletDrug
BI 10773 and metformin single tablets, administered together in fasted state
A: BI 10773 / metformin tabletDrug
BI 10773 / metformin fixed dose combination tablet in fasted state

Study groups in NCT01211197
Study group	Role	What they receive
A	Experimental	3 treatments will be investigated in randomized order Receives: Drug: A: BI 10773 / metformin tablet
B	Experimental	3 treatments will be investigated in randomized order Receives: Drug: B: BI 10773 tablet and metformin tablet
C	Experimental	3 treatments will be investigated in randomized order Receives: Drug: C: BI 10773 / metformin tablet

What is being measured

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

Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
Note the standard deviation is actually the coefficient of variation (CV).
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empa: Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Maximum Measured Concentration (Cmax)
Maximum measured concentration of metformin in plasma.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

Secondary outcomes (9)

Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time from dosing to the maximum concentration of the analyte in plasma.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Terminal Elimination Rate Constant in Plasma (λz)
Terminal elimination rate constant in plasma.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Terminal Half-life in Plasma (T1/2)
Terminal half-life of the analyte in plasma.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Mean Residence Time in the Body After Oral Administration (MRTpo)
Mean residence time of the analyte in the body after oral administration.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Apparent Clearance After Extravascular Administration (CL/F)
Apparent clearance of the analyte in the plasma after extravascular administration.
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Apparent volume of distribution during the terminal phase (λz).
Note the standard deviation is actually the CV.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.
Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Measured: Drug administration up to 7 days after last drug administration, up to 8 days

Timeline

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

Oct 2010Dec 2010

First posted29 Sep 2010 (estimated)
Study startOct 2010
Primary completionDec 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.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01211197
Sponsor's protocol ID: 1276.5
Other IDs: 2010-018589-22
Status last verified: Jul 2015
First submitted: 28 Sep 2010
Last updated: 21 Aug 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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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of a 12.5 mg BI 10773 / 1000 mg Metformin Fixed Dose Combination Tablet Compared With Its Monocomponents and Administered With and Without Food (an Open-label, Randomised, Single-dose, Three-way Crossover, Phase I Trial in Healthy Volunteers)
ClinicalTrials.gov ID: NCT01211197
Acronym / sponsor ID: 1276.5
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Dec 2010 (actual)
First posted: 29 Sep 2010 (estimated)
Results: Posted 21 Aug 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: 3

Arm	Type	Receives
A	Experimental	Drug: A: BI 10773 / metformin tablet3 treatments will be investigated in randomized order
B	Experimental	Drug: B: BI 10773 tablet and metformin tablet3 treatments will be investigated in randomized order
C	Experimental	Drug: C: BI 10773 / metformin tablet3 treatments will be investigated in randomized order

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy males and females according to the following criteria
Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

Key exclusion criteria (2 listed)

Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease

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
C: BI 10773 / metformin tabletBI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal	Drug	C
B: BI 10773 tablet and metformin tabletBI 10773 and metformin single tablets, administered together in fasted state	Drug	B
A: BI 10773 / metformin tabletBI 10773 / metformin fixed dose combination tablet in fasted state	Drug	A

Primary outcome

Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the coefficient of variation (CV).
Empa: Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV.
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the CV.
Metformin: Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of metformin in plasma. Note the standard deviation is actually the CV.

9 secondary outcomes

Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Terminal Elimination Rate Constant in Plasma (λz)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Terminal Half-life in Plasma (T1/2)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Mean Residence Time in the Body After Oral Administration (MRTpo)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Apparent Clearance After Extravascular Administration (CL/F)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.
Time frame: Drug administration up to 7 days after last drug administration, up to 8 days

Results and safety

Results posted to the registry on 21 Aug 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
FDC Fasted / Individual Tablets Fasted / FDC Fed	3	3
FDC Fasted / FDC Fed / Individual Tablets Fasted	3	3
Individual Tablets Fasted / FDC Fasted / FDC Fed	3	3
Individual Tablets Fasted / FDC Fed / FDC Fasted	3	3
FDC Fed / FDC Fasted / Individual Tablets Fasted	2	2
FDC Fed / Individual Tablets Fasted / FDC Fasted	2	2

Primary outcome: Empa: Area Under the Curve 0 to Infinity (AUC0-∞)

Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration. Mean (Standard Deviation). Unit: nmol*h/L

Measure	FDC Fasted n = 15	Individual Tablets Fasted n = 16	FDC Fed n = 14
Value	2920 (16.2)	2860 (18.5)	2710 (15.0)

FDC Fasted vs Individual Tablets Fasted: Geometric mean ratio: 100.59 (90% CI 95.75 to 105.67), ANOVA
FDC Fasted vs FDC Fed: Geometric mean ratio: 94.94 (90% CI 89.85 to 100.33), ANOVA

Population analysed: Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.

Primary outcome: Empa: Maximum Measured Concentration (Cmax)

Measure	FDC Fasted n = 15	Individual Tablets Fasted n = 16	FDC Fed n = 14
Value	404 (17.4)	405 (15.8)	259 (20.3)

FDC Fasted vs Individual Tablets Fasted: Geometric mean ratio: 99.31 (90% CI 91.76 to 107.49), ANOVA
FDC Fasted vs FDC Fed: Geometric mean ratio: 64.30 (90% CI 55.97 to 73.87), ANOVA

Primary outcome: Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)

Measure	FDC Fasted n = 15	Individual Tablets Fasted n = 16	FDC Fed n = 14
Value	10300 (16.9)	10100 (21.2)	10200 (15.6)

FDC Fasted vs Individual Tablets Fasted: Geometric mean ratio: 102.15 (90% CI 93.87 to 111.15), ANOVA
FDC Fasted vs FDC Fed: Geometric mean ratio: 100.67 (90% CI 91.70 to 110.51), ANOVA

Primary outcome: Metformin: Maximum Measured Concentration (Cmax)

Measure	FDC Fasted n = 15	Individual Tablets Fasted n = 16	FDC Fed n = 14
Value	1550 (19.1)	1530 (23.4)	1180 (25.5)

FDC Fasted vs Individual Tablets Fasted: Geometric mean ratio: 103.49 (90% CI 95.30 to 112.39), ANOVA
FDC Fasted vs FDC Fed: Geometric mean ratio: 75.13 (90% CI 63.68 to 88.64), ANOVA

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Drug administration up to 7 days after last drug administration, up to 8 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FDC Fasted	0 of 15 (0%)	2 of 15 (13.3%)	Not reported
Individual Tablets Fasted	0 of 16 (0%)	6 of 16 (37.5%)	Not reported
FDC Fed	0 of 14 (0%)	8 of 14 (57.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 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?

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 2 inclusion and 2 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 21 Aug 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 21 Aug 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?

Empa: Area Under the Curve 0 to Infinity (AUC0-∞) (time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 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 NCT01211197.

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 21 Aug 2015.