HealthyPhase 1NCT02106923

Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets

A Phase 1 study testing 1 tablet Empagliflozin/2 tablets Metformin XR, 10 mg Empagliflozin/1000 mg Metformin XR and 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR in people with Healthy, run by Boehringer Ingelheim at 1 site in United States.

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 demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin \& metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly 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?: 1 tablet Empagliflozin/2 tablets Metformin XR, 10 mg Empagliflozin/1000 mg Metformin XR and 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: Apr 2014to Jul 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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males or females
Age 18-50 years (incl.)
Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
Subjects must be able to understand and comply with study requirements

Who cannot join

Any deviation from healthy condition

Trial locations and contacts

1 site in 1 country.

United States1 site

Boehringer Ingelheim Investigational Site
Austin, Texas

Other trials in United States

About this study

Official title: Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (10 mg/1000 mg and 5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)

Conditions: Healthy
Being tested: 1 tablet Empagliflozin/2 tablets Metformin XR, 10 mg Empagliflozin/1000 mg Metformin XR, 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR, 2 tablets 5 mg Empagliflozin/750 Metformin XR

What participants receive

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

1 tablet Empagliflozin/2 tablets Metformin XRDrug
Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets
10 mg Empagliflozin/1000 mg Metformin XRDrug
Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
1 tablet 10 mg Empagliflozin/3 tablets Metformin XRDrug
Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets
2 tablets 5 mg Empagliflozin/750 Metformin XRDrug
Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets
1 tablet Empagliflozin/2 tablets Metformin XRDrug
Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets
10 mg Empagliflozin/1000 mg Metformin XRDrug
Experimental: high dose Empagliflozin/Metformin XR, FDC tablet

Study groups in NCT02106923
Study group	Role	What they receive
High dose, fasted	Experimental	1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions Receives: Drug: 10 mg Empagliflozin/1000 mg Metformin XR; Drug: 1 tablet Empagliflozin/2 tablets Metformin XR
High dose, fed	Experimental	1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions Receives: Drug: 1 tablet Empagliflozin/2 tablets Metformin XR; Drug: 10 mg Empagliflozin/1000 mg Metformin XR
Low dose, fasted	Experimental	2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions Receives: Drug: 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR; Drug: 2 tablets 5 mg Empagliflozin/750 Metformin XR

What is being measured

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

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
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
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
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin
Maximum measured concentration of empagliflozin in plasma (Cmax).
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin
Maximum measured concentration of metformin in plasma
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Secondary outcomes (2)

AUC0-infinity (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 empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin
Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 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.

Apr 2014Jul 2014

First posted8 Apr 2014 (estimated)
Study startApr 2014
Primary completionJun 2014
Study completionJul 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: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02106923
Sponsor's protocol ID: 1276.14
Status last verified: Jan 2017
First submitted: 4 Apr 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?

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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: Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (10 mg/1000 mg and 5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)
ClinicalTrials.gov ID: NCT02106923
Acronym / sponsor ID: 1276.14
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Apr 2014
Primary completion: Jun 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 8 Apr 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: 3

Arm	Type	Receives
High dose, fasted	Experimental	Drug: 10 mg Empagliflozin/1000 mg Metformin XR, Drug: 1 tablet Empagliflozin/2 tablets Metformin XR1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions
High dose, fed	Experimental	Drug: 1 tablet Empagliflozin/2 tablets Metformin XR, Drug: 10 mg Empagliflozin/1000 mg Metformin XR1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions
Low dose, fasted	Experimental	Drug: 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR, Drug: 2 tablets 5 mg Empagliflozin/750 Metformin XR2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy males or females
Age 18-50 years (incl.)
Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
Subjects must be able to understand and comply with study requirements

Key exclusion criteria (1 listed)

Any deviation from healthy condition

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
1 tablet Empagliflozin/2 tablets Metformin XRActive Comparator: 1 x Empagliflozin/2x Metformin XR tablets	Drug	High dose, fed
10 mg Empagliflozin/1000 mg Metformin XRExperimental: high dose Empagliflozin/Metformin XR, FDC tablet	Drug	High dose, fasted
1 tablet 10 mg Empagliflozin/3 tablets Metformin XRActive Comparator: 1 x Empagliflozin/3 x Metformin XR tablets	Drug	Low dose, fasted
2 tablets 5 mg Empagliflozin/750 Metformin XRExperimental:2 x low dose Empagliflozin/Metformin XR FDC tablets	Drug	Low dose, fasted
1 tablet Empagliflozin/2 tablets Metformin XRActive Comparator: 1 x Empagliflozin/2x Metformin XR tablets	Drug	High dose, fasted
10 mg Empagliflozin/1000 mg Metformin XRExperimental: high dose Empagliflozin/Metformin XR, FDC tablet	Drug	High dose, fed

Primary outcome

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
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
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
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Maximum measured concentration of empagliflozin in plasma (Cmax).
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Maximum measured concentration of metformin in plasma

2 secondary outcomes

AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h 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
Empa+1000mg Met FDC / Empa+1000mg Glumetza® (Fasted)	12	12
Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fasted)	12	12
Empa+1000mg Met FDC / Empa+1000mg Glumetza (Fed)	12	12
Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fed)	12	12
Empa+1500mg Met FDC / Empa+1500mg Glumetza (Fasted)	12	12
Empa+1500mg Glumetza / Empa+1500mg Met FDC (Fasted)	12	11

Primary outcome: 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

Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Empa/1000 mg Glumetza® (Fasted) n = 24	Empa/ 1000 mg Met FDC (Fasted) n = 24	Empa/1000 mg Glumetza ® (Fed) n = 24	Empa/ 1000 mg Met FDC (Fed) n = 23	Empa/ 1500 mg Glumetza® (Fasted) n = 24	Empa/ 1500 mg Met FDC (Fasted) n = 23
Value	2630 (18.9)	2710 (18.3)	2720 (20.5)	2710 (19.9)	2790 (17.3)	2680 (18.7)

Empa/1000 mg Glumetza® (Fasted) vs Empa/ 1000 mg Met FDC (Fasted): Adjusted geometric mean ratio (%): 102.98 (90% CI 100.505 to 105.514), p <0.0001, ANOVA
Empa/1000 mg Glumetza ® (Fed) vs Empa/ 1000 mg Met FDC (Fed): Adjusted geometric mean ratio (%): 100.25 (90% CI 96.809 to 103.823), p <0.0001, ANOVA
Empa/ 1500 mg Glumetza® (Fasted) vs Empa/ 1500 mg Met FDC (Fasted): Adjusted geometric mean ratio (%): 96.08 (90% CI 93.507 to 98.721), p <0.0001, ANOVA

Population analysed: Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.

Primary outcome: 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

Measure	Empa/1000 mg Glumetza® (Fasted) n = 24	Empa/ 1000 mg Met FDC (Fasted) n = 24	Empa/1000 mg Glumetza ® (Fed) n = 24	Empa/ 1000 mg Met FDC (Fed) n = 23	Empa/ 1500 mg Glumetza® (Fasted) n = 24	Empa/ 1500 mg Met FDC (Fasted) n = 23
Value	7020 (35.2)	7170 (36.2)	13500 (19.1)	13200 (18.8)	9860 (26.4)	10100 (25.6)

Empa/1000 mg Glumetza® (Fasted) vs Empa/ 1000 mg Met FDC (Fasted): Adjusted geometric mean ratio (%): 102.04 (90% CI 92.30 to 112.81), p = 0.0011, ANOVA
Empa/1000 mg Glumetza ® (Fed) vs Empa/ 1000 mg Met FDC (Fed): Adjusted geometric mean ratio (%): 98.93 (90% CI 95.45 to 102.53), p <0.0001, ANOVA
Empa/ 1500 mg Glumetza® (Fasted) vs Empa/ 1500 mg Met FDC (Fasted): Adjusted geometric mean ratio (%): 101.70 (90% CI 93.59 to 110.52), p = 0.0002, ANOVA

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

Measure	Empa/1000 mg Glumetza® (Fasted) n = 24	Empa/ 1000 mg Met FDC (Fasted) n = 24	Empa/1000 mg Glumetza ® (Fed) n = 24	Empa/ 1000 mg Met FDC (Fed) n = 23	Empa/ 1500 mg Glumetza® (Fasted) n = 24	Empa/ 1500 mg Met FDC (Fasted) n = 23
Value	377 (22.5)	395 (24.6)	273 (27.6)	277 (31.0)	396 (21.9)	381 (22.0)

Empa/1000 mg Glumetza® (Fasted) vs Empa/ 1000 mg Met FDC (Fasted): Adjusted geometric mean ratio (%): 104.83 (90% CI 99.522 to 110.412), p <0.0001, ANOVA
Empa/1000 mg Glumetza ® (Fed) vs Empa/ 1000 mg Met FDC (Fed): Adjusted geometric mean ratio (%): 101.84 (90% CI 95.030 to 109.134), p <0.0001, ANOVA
Empa/ 1500 mg Glumetza® (Fasted) vs Empa/ 1500 mg Met FDC (Fasted): Adjusted geometric mean ratio (%): 96.03 (90% CI 90.217 to 102.211), p <0.0001, ANOVA

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

Measure	Empa/1000 mg Glumetza® (Fasted) n = 24	Empa/ 1000 mg Met FDC (Fasted) n = 24	Empa/1000 mg Glumetza ® (Fed) n = 24	Empa/ 1000 mg Met FDC (Fed) n = 23	Empa/ 1500 mg Glumetza® (Fasted) n = 24	Empa/ 1500 mg Met FDC (Fasted) n = 23
Value	975 (37.2)	964 (39.9)	1110 (21.2)	1200 (22.7)	1220 (32.8)	1270 (34.7)

Empa/1000 mg Glumetza® (Fasted) vs Empa/ 1000 mg Met FDC (Fasted): Adjusted geometric mean ratio (%): 98.94 (90% CI 87.925 to 111.329), p = 0.0027, ANOVA
Empa/1000 mg Glumetza ® (Fed) vs Empa/ 1000 mg Met FDC (Fed): Adjusted geometric mean ratio (%): 108.18 (90% CI 102.792 to 113.859), p <0.0001, ANOVA
Empa/ 1500 mg Glumetza® (Fasted) vs Empa/ 1500 mg Met FDC (Fasted): Adjusted geometric mean ratio (%): 103.62 (90% CI 92.116 to 116.559), p = 0.0060, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until next treatment period or follow-up visit, 10 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empa/1000 mg Glumetza® (Fasted)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Empa/ 1000 mg Met FDC (Fasted)	0 of 24 (0%)	5 of 24 (20.8%)	Not reported
Empa/1000 mg Glumetza ® (Fed)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Empa/ 1000 mg Met FDC (Fed)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Empa/ 1500 mg Glumetza® (Fasted)	0 of 24 (0%)	6 of 24 (25%)	Not reported
Empa/ 1500 mg Met FDC (Fasted)	0 of 23 (0%)	7 of 23 (30.4%)	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?

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 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 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 United States. 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 (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 (time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 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 NCT02106923.

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.