Diabetes Mellitus, Type 2Phase 1NCT01907113

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment

A Phase 1 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 2 sites 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

Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773 Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesGermany
Study dates: Jul 2009to Dec 2009
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects with type 2 diabetes
Renally impaired male or female subjects
Age 18 - 75 years
BMI 18 - 34 kg/m2, at least 45 kg for females (Body Mass Index)
Signed and dated written informed consent

Who cannot join

Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
Relevant gastrointestinal tract surgery
Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure < 100 or > 160 mm Hg, diastolic blood pressure < 60 or > 100 mm Hg, pulse rate < 50 or > 100 1/min
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator

Show all 11Show fewer

Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation. Co medication known to inhibit or induce P-glycoprotein or CYP3A is not allowed. Inhibitors of P-glycoprotein or CYP3A (cytochrom P3A) are e.g.
protease inhibitors, (e.g. ritonavir, lopinavir nelfinavir)
azole antimycotics, (itraconazole, ketoconazole, miconazole)
macrolid antibiotics, (clarithromycin, erythromycin)
amiodarone, cimetidine, diltiazem, fluvoxamine, mibefradil, nefazodone, verapamil, tacrolimus, quinidine, reserpine, cyclosporine A Inducers of P-gp or CYP3A are e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, ri-fampin, St. John's wort, troglitazone. In dubious cases, a case by case decision will be made after consultation with the sponsor.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

1245.12.1 Boehringer Ingelheim Investigational Site
Kiel
1245.12.2 Boehringer Ingelheim Investigational Site
Neuss

Other trials in Germany

About this study

Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single 50 mg Dose of BI 10773 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Type 2 Diabetes and Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase 1 Trial

Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773
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.

BI 10773Drug
oral administration
BI 10773Drug
oral administration
BI 10773Drug
oral administration
BI 10773Drug
oral administration
BI 10773Drug
oral administration

Study groups in NCT01907113
Study group	Role	What they receive
BI 10773 / Group 2	Experimental	Single Dose Administration (type 2 diabetes and mild renal impairment) Receives: Drug: BI 10773
BI 10773 / Group 3	Experimental	Single Dose Administration (type 2 diabetes and moderate renal impairment) Receives: Drug: BI 10773
BI 10773 / Group 4	Experimental	Single Dose Administration (severe renal impairment 8) Receives: Drug: BI 10773
BI 10773 / Group 5	Experimental	Single Dose Administration (kidney failure) Receives: Drug: BI 10773
BI 10773 / Group 1	Experimental	Single Dose Administration (type 2 diabetes and normal renal function) Receives: Drug: BI 10773

What is being measured

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

AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity)
Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.
Measured: 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Cmax (Maximum Concentration of the Analyte in Plasma)
Maximum concentration of Empagliflozin in plasma
Measured: 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration

Secondary outcomes (14)

Time to Maximum Concentration of the Analyte in Plasma
Time from last dosing to maximum concentration of Empagliflozin in plasma (tmax)
Measured: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Half-life and Mean Residence Time of the Analyte in Plasma
Terminal half-life of Empagliflozin (t1/2) and Mean residence time of Empagliflozin in the body
Measured: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Terminal Rate Constant in Plasma
Terminal rate constant in plasma (Lz)
Measured: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Apparent Clearance of the Analyte in the Plasma After Extravascular Administration
Apparent clearance of the analyte in the plasma after extravascular administration
Measured: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Apparent Volume of Distribution During the Terminal Phase Lz
Apparent volume of distribution during the terminal phase Lz
Measured: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.
Measured: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Ae0-96 (Amount of Analyte That is Eliminated in Urine Over the Time Interval 0 to 96 h)
Amount of analyte that is eliminated in urine over the time interval 0-96 hours.
Measured: 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration
fe0-96 (Fraction of Analyte Excreted Unchanged in Urine From Time Points 0 to 96 Hours)
Fraction of analyte excreted unchanged in urine from time point 0-96 hours.
Measured: 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration
Renal Clearance of the Analyte in Plasma After Extravascular Administration
Renal Clearance of the Analyte in Plasma After Extravascular Administration for time interval 0-96 hours.
Measured: 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration
%AUCtz-∞ (Percentage of Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From the Time of the Last Quantifiable Data Point Extrapolated to Infinity)
Percentage of area under the concentration-time curve of the analyte in plasma over the time interval from the time of the last quantifiable data point extrapolated to infinity
Measured: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Plasma Protein Binding
Plasma protein binding is the percent of analyte binding to the plasma protein, pre-dose plasma samples were spiked with Empa 1000 nmol/L.
The standard deviation is actually the coefficient of variation.
Measured: 1 h before drug administration and 1:30 and 3:00 h after drug administration
Total Urinary Glucose Excretion (UGE)
Change from baseline in total urinary glucose excretion
Measured: 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration (Interval 24-0 h before drug administration only for baseline UGE)
Safety: Physical Examination, Vital Signs, ECG and Laboratory Measurements
Number of participants with clinically relevant findings in physical examination, Vital Signs, Clinically Significant Abnormalities in Electrocardiogram (ECG) and Significant Changes from Baseline Laboratory Measurements
Measured: Drug administration until end-of-study-examination, 5 days
Assessment of Tolerability by Investigator
Tolerability was assessed by the investigator based on adverse events and the laboratory evaluation.
Measured: Drug administration until end-of-study-examination, 5 days

Timeline

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

Jul 2009Dec 2009

First posted24 Jul 2013 (estimated)
Study startJul 2009
Primary completionDec 2009
Study completionDec 2009

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01907113
Sponsor's protocol ID: 1245.12
Other IDs: 2008-006086-86, 2008
Status last verified: Jul 2014
First submitted: 15 Jul 2013
Last updated: 14 Jul 2014
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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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single 50 mg Dose of BI 10773 in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Type 2 Diabetes and Normal Renal Function in a Monocentric, Open-label, Parallel-group, Phase 1 Trial
ClinicalTrials.gov ID: NCT01907113
Acronym / sponsor ID: 1245.12
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 24 Jul 2013 (estimated)
Results: Posted 14 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
BI 10773 / Group 2	Experimental	Drug: BI 10773Single Dose Administration (type 2 diabetes and mild renal impairment)
BI 10773 / Group 3	Experimental	Drug: BI 10773Single Dose Administration (type 2 diabetes and moderate renal impairment)
BI 10773 / Group 4	Experimental	Drug: BI 10773Single Dose Administration (severe renal impairment 8)
BI 10773 / Group 5	Experimental	Drug: BI 10773Single Dose Administration (kidney failure)
BI 10773 / Group 1	Experimental	Drug: BI 10773Single Dose Administration (type 2 diabetes and normal renal function)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and female subjects with type 2 diabetes
Renally impaired male or female subjects
Age 18 - 75 years
BMI 18 - 34 kg/m2, at least 45 kg for females (Body Mass Index)
Signed and dated written informed consent

Key exclusion criteria (11 listed)

Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
Relevant gastrointestinal tract surgery
Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure < 100 or > 160 mm Hg, diastolic blood pressure < 60 or > 100 mm Hg, pulse rate < 50 or > 100 1/min
Chronic or relevant acute infections

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
BI 10773oral administration	Drug	BI 10773 / Group 2
BI 10773oral administration	Drug	BI 10773 / Group 1
BI 10773oral administration	Drug	BI 10773 / Group 3
BI 10773oral administration	Drug	BI 10773 / Group 4
BI 10773oral administration	Drug	BI 10773 / Group 5

Primary outcome

AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity)
Time frame: 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.
Cmax (Maximum Concentration of the Analyte in Plasma)
Time frame: 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Maximum concentration of Empagliflozin in plasma

14 secondary outcomes

Time to Maximum Concentration of the Analyte in Plasma
Time frame: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Half-life and Mean Residence Time of the Analyte in Plasma
Time frame: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Terminal Rate Constant in Plasma
Time frame: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Apparent Clearance of the Analyte in the Plasma After Extravascular Administration
Time frame: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Apparent Volume of Distribution During the Terminal Phase Lz
Time frame: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
Time frame: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Ae0-96 (Amount of Analyte That is Eliminated in Urine Over the Time Interval 0 to 96 h)
Time frame: 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration
fe0-96 (Fraction of Analyte Excreted Unchanged in Urine From Time Points 0 to 96 Hours)
Time frame: 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration
Renal Clearance of the Analyte in Plasma After Extravascular Administration
Time frame: 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration
%AUCtz-∞ (Percentage of Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From the Time of the Last Quantifiable Data Point Extrapolated to Infinity)
Time frame: 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration
Plasma Protein Binding
Time frame: 1 h before drug administration and 1:30 and 3:00 h after drug administration
Total Urinary Glucose Excretion (UGE)
Time frame: 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration (Interval 24-0 h before drug administration only for baseline UGE)
Safety: Physical Examination, Vital Signs, ECG and Laboratory Measurements
Time frame: Drug administration until end-of-study-examination, 5 days
Assessment of Tolerability by Investigator
Time frame: Drug administration until end-of-study-examination, 5 days

Results and safety

Results posted to the registry on 14 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Renal Function	8	8
Mild Renal Impairment	9	9
Moderate Renal Impairment	7	7
Severe Renal Impairment	8	8
Kidney Failure	8	8

Primary outcome: AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity)

Time frame: 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 9	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 8	Kidney Failure n = 8
Value	10500 (17.6)	12400 (21.6)	12600 (27.1)	17500 (18.9)	15600 (38.6)

Normal Renal Function vs Mild Renal Impairment: Geometric mean ratio: 118.24 (90% CI 96.17 to 145.38), ANOVA
Normal Renal Function vs Moderate Renal Impairment: Geometric mean ratio: 119.94 (90% CI 96.25 to 149.47), ANOVA
Normal Renal Function vs Severe Renal Impairment: Geometric mean ratio: 166.29 (90% CI 134.44 to 205.68), ANOVA

Population analysed: The PK analysis set (PKS) included all evaluable patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.

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

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 9	Moderate Renal Impairment n = 7	Severe Renal Impairment n = 8	Kidney Failure n = 8
Value	1210 (24.1)	1430 (33.1)	1230 (30.9)	1450 (33.0)	1250 (25.9)

Normal Renal Function vs Mild Renal Impairment: Geometric mean ratio: 118.83 (90% CI 93.62 to 150.84), ANOVA
Normal Renal Function vs Moderate Renal Impairment: Geometric mean ratio: 102.27 (90% CI 79.33 to 131.85), ANOVA
Normal Renal Function vs Severe Renal Impairment: Geometric mean ratio: 120.68 (90% CI 94.42 to 154.25), ANOVA

Population analysed: PKS

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until end of trial examination, 5 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Renal Function	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Mild Renal Impairment	0 of 9 (0%)	0 of 9 (0%)	Not reported
Moderate Renal Impairment	0 of 7 (0%)	1 of 7 (14.3%)	Not reported
Severe Renal Impairment	0 of 8 (0%)	0 of 8 (0%)	Not reported
Kidney Failure	0 of 8 (0%)	2 of 8 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 2 sites 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 5 inclusion and 11 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 14 Jul 2014). 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-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity) (time frame: 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration). The study lists 2 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 NCT01907113.

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 14 Jul 2014.