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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773

• Registration Number: NCT01907113
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-24
• Results First Submitted: 2014-05-16
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-11
• Results First Posted: 2014-07-14
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 10773 / Group 4	BI 10773	Single Dose Administration (severe renal impairment 8)
BI 10773 / Group 3	BI 10773	Single Dose Administration (type 2 diabetes and moderate renal impairment)
BI 10773 / Group 1	BI 10773	Single Dose Administration (type 2 diabetes and normal renal function)
BI 10773 / Group 2	BI 10773	Single Dose Administration (type 2 diabetes and mild renal impairment)
BI 10773 / Group 5	BI 10773	Single Dose Administration (kidney failure)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to Maximum Concentration of the Analyte in Plasma	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	Time from last dosing to maximum concentration of Empagliflozin in plasma (tmax)
fe0-96 (Fraction of Analyte Excreted Unchanged in Urine From Time Points 0 to 96 Hours)	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	Fraction of analyte excreted unchanged in urine from time point 0-96 hours.
Half-life and Mean Residence Time of the Analyte in Plasma	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 half-life of Empagliflozin (t1/2) and Mean residence time of Empagliflozin in the body
Terminal Rate Constant in Plasma	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 (Lz)
Apparent Clearance of the Analyte in the Plasma After Extravascular Administration	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 Volume of Distribution During the Terminal Phase Lz	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
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)	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	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.
Ae0-96 (Amount of Analyte That is Eliminated in Urine Over the Time Interval 0 to 96 h)	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	Amount of analyte that is eliminated in urine over the time interval 0-96 hours.
Renal Clearance of the Analyte in Plasma After Extravascular Administration	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 for time interval 0-96 hours.
%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)	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	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
Plasma Protein Binding	1 h before drug administration and 1:30 and 3:00 h after drug administration	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.
Total Urinary Glucose Excretion (UGE)	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)	Change from baseline in total urinary glucose excretion
Safety: Physical Examination, Vital Signs, ECG and Laboratory Measurements	Drug administration until end-of-study-examination, 5 days	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
Assessment of Tolerability by Investigator	Drug administration until end-of-study-examination, 5 days	Tolerability was assessed by the investigator based on adverse events and the laboratory evaluation.

Trial Locations

Locations (2)

1245.12.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Kiel, Germany

1245.12.2 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany