Diabetes Mellitus, Type 2Phase 1NCT01924767

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets

A Phase 1 study testing BI 10773 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

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state. Read more about this study

Who is it for?: Ages 18 to 70 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?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteGermany
Study dates: Jul 2007to Nov 2007
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.
Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening.
Age >21 and Age <70 years (male and hysterectomised female patients) Age >60 and Age <70 years (postmenopausal female patients)
Body Mass Index (BMI) >18.5 and <40 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Who cannot join

Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)
Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) on two consecutive days during washout.
Glycosylated haemoglobin A1 (HbA1c) >8.5% at screening
Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)
Renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²)

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Cardiac insufficiency NYHA II-IV, myocardial infarction, other known cardiovascular diseases including hypertension > 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA (Transistoric ischaemic attack)
Neurological disorders (such as epilepsy) or psychiatric disorders
Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections)
Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
A history of additional risk factors for TdP (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)

Trial locations and contacts

1 site in 1 country.

Germany1 site

1245.2.1 Boehringer Ingelheim Investigational Site
Neuss

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Multiple Rising Oral Doses (2.5 mg to 100 mg) of BI 10773 Tablets in Male and Female Type 2 Diabetic Patients

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773 Placebo, 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 10773 PlaceboDrug
po taken fasting with 240 mL water
BI 10773Drug
po taken fasting with 240 mL water
BI 10773 PlaceboDrug
po taken fasting with 240 mL water
BI 10773Drug
po taken fasting with 240 mL water
BI 10773 PlaceboDrug
po taken fasting with 240 mL water
BI 10773 PlaceboDrug
po taken fasting with 240 mL water
BI 10773Drug
po taken fasting with 240 mL water
BI 10773Drug
po taken fasting with 240 mL water

Study groups in NCT01924767
Study group	Role	What they receive
BI 10773 (dose group 3)	Experimental	multiple doses as tablet Receives: Drug: BI 10773 Placebo; Drug: BI 10773
BI 10773 (dose group 4)	Experimental	multiple doses as tablet Receives: Drug: BI 10773; Drug: BI 10773 Placebo
BI 10773 (dose group 1)	Experimental	multiple doses as tablet Receives: Drug: BI 10773 Placebo; Drug: BI 10773
BI 10773 (dose group 2)	Experimental	multiple doses as tablet Receives: Drug: BI 10773 Placebo; Drug: BI 10773

What is being measured

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

Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests
Percentage of participants with clinically relevant findings in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).
Measured: day 1 to day 21
Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results
Percentage of participants with clinically relevant findings in electrocardiogram (ECG) results
Measured: day 1 to day 21
Micturition Frequency
Micturition frequency is reported as change from pre-treatment to day 9 during the day, the night and total. Baseline is the mean of days 8-3 before drug administration.
Measured: Baseline and Day 9
Assessment of Tolerability by Investigator
Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.
Measured: day 21

Secondary outcomes (17)

Concentration of the Analyte in Plasma
Maximum concentration of the analyte in plasma (Cmax) after first dose, Maximum, minimum (Cmin) and average (Cavg) concentration of the analyte in plasma at steady-state, Concentration of analyte in plasma at 24 h after administration of the 8th dose (at steady-state) (C24,8)
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval (AUC)
AUC0-∞: from 0 extrapolated to infinity after first dose AUCtau,1: over a uniform dosing interval tau after first dose AUCtau,ss: over a uniform dosing interval tau at steady-state AUCs were computed using the linear up/log down algorithm. If an analyte concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was to be used. If the analyte concentration was smaller than the preceding concentration, the logarithmic method was to be used.
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Time to Maximum Concentration of the Analyte in Plasma
Time from last dosing to maximum concentration of the analyte in plasma (tmax) after first dose and at steady-state
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Terminal Rate Constant in Plasma
Terminal rate constant in plasma after first dose and at steady-state
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Half-life and Mean Residence Time of the Analyte in Plasma
Terminal half life of the analyte in plasma (t1/2) and mean residence time of the analyte in the body after single oral administration (MRTpo) after first dose and at steady-state.
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Apparent Volume of Distribution During the Terminal Phase
Apparent volume of distribution during the terminal phase (Vz/F) after first dose and at steady state. Apparent volume is defined as CL/F divided by the terminal rate constant in plasma (either after first dose or at steady-state).
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Amount of Analyte Eliminated in Urine
Amount of analyte that is eliminated in urine after first dose and at steady state from the time interval 0 to 24 h (Ae0-24) and 0 to 48 h (Ae0-48)
Measured: 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9
Fraction of Analyte Excreted Unchanged in Urine
Fraction of analyte excreted unchanged in urine in the time interval 0 to 12 h (fe0-12) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-12 by the Dose and multiply it with 100.
Fraction of analyte excreted unchanged in urine in the time interval 0 to 24 h (fe0-24) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-24 by the Dose and multiply it with 100.
Measured: 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9
Apparent and Renal Clearance of the Analyte in Plasma
Apparent clearance of the analyte in plasma (CL/F) after first dose and at steady-state, Renal clearance of the analyte in plasma after extravascular administration (CLR) after first dose and at steady-state.
Apparent clearance after first dose is defined as the dose divided by AUC0-∞; apparent clearance at steady-state is defined as the dose divided by AUC0-tau at steady-state.
Renal clearance CLR(0-t) is defined as Ae0-t divided by AUC0-t.
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Peak Trough Fluctuation
Peak trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Linearity Index
The linearity index is defined as AUC0-tau divided by AUC0-∞ both at steady state.
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Accumulation Ratios
Accumulation ratio based on Cmax (RA,Cmax) and Accumulated ratio based on AUC0-tau (RA,AUC) at steady-state.
Accumulation ratio for the respective doses were calculated using below mentioned equations:
RA,Cmax = Cmax,ss/Cmax
RA,AUC= AUCtau,ss/AUCtau
Measured: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Change From Baseline to Day 8 in Urinary Glucose Excretion
Change from baseline to day 8 in urinary glucose excretion. Baseline is defined as Day -2.
Measured: -2-0 hours(h) before drug administration and 0-2, 2-4, 4-6, 6-8, 8-12,12-16 and 16-24 h after drug administration on day -2 and day 8
Mean Daily Glucose
Change from baseline to Day 8 in mean daily glucose. Baseline is defined as Day -2.
Measured: 0:00, 2:00, 5:00, 7:00, 10:00, 12:00,13:30 and 24:00 hours(h) after drug administration on day -2 and -0.05, 2:30, 5:00, 7:00, 10:00, 12.00, 13:30 and 24:00 hours (h) after drug administration on day 8
Fasting Plasma Glucose
Percentage change from baseline to Day 8 in fasting plasma glucose. Baseline is defined as Day -2.
Measured: -0:30 (Pre dose samples)
Serum Insulin
Serum insulin measured for on day -2 and day 8 for AUEC0-5 and AUEC0-12. AUEC0-5: The area under the effect concentration-time curve over the time interval 0 to 5.
AUEC0-12: The area under the effect concentration-time curve over the time interval 0 to 12.
Measured: 0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8
Serum Insulin
Serum insulin measured for on day -2 and day 8 for Emax0-5, Emax0-12, Emin0-5 and Emin0-12.
Emax: Maximum effect (maximum measured concentration of glucose or insulin in plasma) \& Emin: Minimum effect (minimum measured concentration of glucose or insulin in plasma)
Measured: 0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8

Timeline

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

Jul 2007Nov 2007

First posted16 Aug 2013 (estimated)
Study startJul 2007
Primary completionNov 2007
Study completionNov 2007

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: Single group
Masking: Double blind
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01924767
Sponsor's protocol ID: 1245.2
Other IDs: 2007-000654-32
Status last verified: Jul 2014
First submitted: 9 Aug 2013
Last updated: 4 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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Multiple Rising Oral Doses (2.5 mg to 100 mg) of BI 10773 Tablets in Male and Female Type 2 Diabetic Patients
ClinicalTrials.gov ID: NCT01924767
Acronym / sponsor ID: 1245.2
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 16 Aug 2013 (estimated)
Results: Posted 4 Jul 2014

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: Single group
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
BI 10773 (dose group 3)	Experimental	Drug: BI 10773 Placebo, Drug: BI 10773multiple doses as tablet
BI 10773 (dose group 4)	Experimental	Drug: BI 10773, Drug: BI 10773 Placebomultiple doses as tablet
BI 10773 (dose group 1)	Experimental	Drug: BI 10773 Placebo, Drug: BI 10773multiple doses as tablet
BI 10773 (dose group 2)	Experimental	Drug: BI 10773 Placebo, Drug: BI 10773multiple doses as tablet

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.
Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening.
Age >21 and Age <70 years (male and hysterectomised female patients) Age >60 and Age <70 years (postmenopausal female patients)
Body Mass Index (BMI) >18.5 and <40 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Key exclusion criteria (13 listed)

Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)
Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) on two consecutive days during washout.
Glycosylated haemoglobin A1 (HbA1c) >8.5% at screening
Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)

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 10773 Placebopo taken fasting with 240 mL water	Drug	BI 10773 (dose group 2)
BI 10773po taken fasting with 240 mL water	Drug	BI 10773 (dose group 4)
BI 10773 Placebopo taken fasting with 240 mL water	Drug	BI 10773 (dose group 3)
BI 10773po taken fasting with 240 mL water	Drug	BI 10773 (dose group 3)
BI 10773 Placebopo taken fasting with 240 mL water	Drug	BI 10773 (dose group 1)
BI 10773 Placebopo taken fasting with 240 mL water	Drug	BI 10773 (dose group 4)
BI 10773po taken fasting with 240 mL water	Drug	BI 10773 (dose group 2)
BI 10773po taken fasting with 240 mL water	Drug	BI 10773 (dose group 1)

Primary outcome

Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests
Time frame: day 1 to day 21
Percentage of participants with clinically relevant findings in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).
Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results
Time frame: day 1 to day 21
Percentage of participants with clinically relevant findings in electrocardiogram (ECG) results
Micturition Frequency
Time frame: Baseline and Day 9
Micturition frequency is reported as change from pre-treatment to day 9 during the day, the night and total. Baseline is the mean of days 8-3 before drug administration.
Assessment of Tolerability by Investigator
Time frame: day 21
Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.

17 secondary outcomes

Concentration of the Analyte in Plasma
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval (AUC)
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Time to Maximum Concentration of the Analyte in Plasma
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Terminal Rate Constant in Plasma
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Half-life and Mean Residence Time of the Analyte in Plasma
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Apparent Volume of Distribution During the Terminal Phase
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Amount of Analyte Eliminated in Urine
Time frame: 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9
Fraction of Analyte Excreted Unchanged in Urine
Time frame: 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9
Apparent and Renal Clearance of the Analyte in Plasma
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Peak Trough Fluctuation
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Linearity Index
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Accumulation Ratios
Time frame: -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.
Change From Baseline to Day 8 in Urinary Glucose Excretion
Time frame: -2-0 hours(h) before drug administration and 0-2, 2-4, 4-6, 6-8, 8-12,12-16 and 16-24 h after drug administration on day -2 and day 8
Mean Daily Glucose
Time frame: 0:00, 2:00, 5:00, 7:00, 10:00, 12:00,13:30 and 24:00 hours(h) after drug administration on day -2 and -0.05, 2:30, 5:00, 7:00, 10:00, 12.00, 13:30 and 24:00 hours (h) after drug administration on day 8
Fasting Plasma Glucose
Time frame: -0:30 (Pre dose samples)
Serum Insulin
Time frame: 0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8
Serum Insulin
Time frame: 0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8

Results and safety

Results posted to the registry on 4 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
Placebo	12	11
Empagliflozin 2.5 mg qd	9	9
Empagliflozin 10 mg qd	9	8
Empagliflozin 25 mg qd	9	9
Empagliflozin 100 mg qd	9	9

Primary outcome: Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests

Time frame: day 1 to day 21. Number. Unit: percentage of participants

Measure	Placebo n = 12	Empagliflozin 2.5 mg qd n = 9	Empagliflozin 10 mg qd n = 9	Empagliflozin 25 mg qd n = 9	Empagliflozin 100 mg qd n = 9
Cardiac disorders	0.0	0.0	0.0	0.0	0.0
Investigations: Hepatic enzyme increased	8.3	0.0	0.0	0.0	0.0

Population analysed: Treated set.

Primary outcome: Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results

Time frame: day 1 to day 21. Number. Unit: percentage of participants

Measure	Placebo n = 12	Empagliflozin 2.5 mg qd n = 9	Empagliflozin 10 mg qd n = 9	Empagliflozin 25 mg qd n = 9	Empagliflozin 100 mg qd n = 9
Clinically relevant	0.0	0.0	0.0	0.0	0.0
Clinically irrelevant	100.0	100.0	100.0	100.0	100.0

Population analysed: Treated set

Primary outcome: Micturition Frequency

Time frame: Baseline and Day 9. Mean (Standard Deviation). Unit: frequency of micturition

Measure	Placebo n = 12	Empagliflozin 2.5 mg qd n = 9	Empagliflozin 10 mg qd n = 9	Empagliflozin 25 mg qd n = 9	Empagliflozin 100 mg qd n = 9
Micturition day frequency	4.1 (1.8)	2.6 (2.1)	5.0 (1.6)	3.9 (1.5)	4.4 (2.1)
Micturition night frequency	0.3 (1.6)	0.2 (1.2)	0.5 (0.5)	0.6 (1.6)	0.7 (0.9)
Micturition total frequency	4.5 (2.1)	2.8 (2.6)	5.5 (1.5)	4.4 (2.4)	5.1 (2.2)

Population analysed: Treated set

Primary outcome: Assessment of Tolerability by Investigator

Time frame: day 21. Number. Unit: percentage of participants

Measure	Placebo n = 12	Empagliflozin 2.5 mg qd n = 9	Empagliflozin 10 mg qd n = 9	Empagliflozin 25 mg qd n = 9	Empagliflozin 100 mg qd n = 9
Good	91.7	100.0	100.0	100.0	100.0
Satisfactory	0.0	0.0	0.0	0.0	0.0
Not satisfactory	0.0	0.0	0.0	0.0	0.0
Bad	8.3	0.0	0.0	0.0	0.0

Population analysed: Treated set

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: day1 to day21. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
Empagliflozin 2.5 mg qd	0 of 9 (0%)	6 of 9 (66.7%)	Not reported
Empagliflozin 10 mg qd	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
Empagliflozin 25 mg qd	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
Empagliflozin 100 mg qd	0 of 9 (0%)	3 of 9 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
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 BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 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 4 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 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 4 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?

Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests (time frame: day 1 to day 21). 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 NCT01924767.

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 4 Jul 2014.