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Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

BI10773

Placebo

BI10773

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Chinese male and 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 thiazolidinediones with at least one agent taken at 50% of its maximum dose or less, unchanged for at least 12 weeks before randomization
Glycosylated haemoglobin A1(HbA1c)<=8.5% and >=7.0% at screening,age>=21 and age<=70 years (male and female patients),BMI>=19 and <=40 kg/m2
Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.

Exclusion criteria:

Patient who did not discontinue the antidiabetic treatment with insulin or glitazones, DPP-IV at least before 12 weeks before randomization
Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast at screening visit
Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:

4 Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot) 5 Renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²) 6 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 7 Neurological disorders (such as epilepsy) or psychiatric disorders 8 Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections) 9 Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder 10. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 11. A marked baseline prolongation of QT/QTc interval (e.g., ECG demonstration of a QTc interval >450 ms ) at screening visit

Sites / Locations

1245.44.86001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

BI10773 low dose Per Os(p.o.)

Placebo

BI10773 high dose Per Os(p.o.)

Arm Description

patient to receive a tablet containing low dose BI10773 Per Os(p.o.) plus one placebo

patient to receive two placebos

patient to receive a tablet containing high dose BI10773 Per Os(p.o.) plus one placebo

Outcomes

Primary Outcome Measures

Maximum Measured Concentration (Cmax)

Maximum measured concentration of the analyte in plasma after the first dose on day 1.

Time to Maximum Measured Concentration (Tmax)

Time from dosing to the maximum measured concentration of the analyte in plasma, after the first dose on day 1.

Area Under the Curve 0 to Infinity (AUC0-∞) After Single Dosing

Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity, after the first dose on day 1

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, after the first dose on day 1.

Terminal Rate Constant (λz)

Terminal Rate Constant in Plasma (λz), after the first dose on day 1

Terminal Half-life (t1/2)

Terminal half-life of empagliflozin (empa) in plasma after the first dose on day 1

Mean Residence Time (MRTpo)

Mean residence time of empagliflozin (empa) in the body after the first dose on day 1.

Apparent Clearance of Empagliflozin After Extravascular Administration (CL/F)

Apparent clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.

Apparent Volume of Distribution During the Terminal Phase λz (Vz/F)

Apparent volume of distribution during the terminal phase λz, after the first dose on day 1.

Amount of Empagliflozin Eliminated in Urine in the Time Interval 0 Hours to 24 Hours (Ae 0-24)

Amount of empagliflozin (empa) eliminated in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.

Fraction of Empagliflozin Excreted Unchanged in Urine in the Time Interval 0 Hours to 24 Hours (fe 0-24).

Fraction of empagliflozin (empa) excreted unchanged in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.

Renal Clearance After Extravascular Administration (CL R,0-48)

Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.

Maximum Measured Concentration Over a Uniform Dosing Interval (Cmax,ss)

Maximum measured concentration of empagliflozin (empa) in plasma at steady state over a uniform dosing interval.

Time From Last Dosing to Maximum Measured Concentration Over a Uniform Dosing Interval at Steady State (Tmax,ss)

Time from last dosing to maximum measured concentration of empagliflozin (empa) in plasma over a uniform dosing interval at steady state, after multiple dosing.

Area Under the Concentration-time Curve in Plasma at Steady State Over a Uniform Dosing Interval (AUCτ,ss)

Area under the concentration-time curve of empagliflozin (empa) in plasma at steady state over a uniform dosing interval, after multiple dosing

Terminal Rate Constant in Plasma at Steady State (λz,ss)

Terminal rate constant in plasma at steady state, after multiple dosing.

Terminal Half-life in Plasma at Steady State (t1/2,ss)

Terminal half-life of empagliflozin (empa) in plasma at steady state, after multiple dosing.

Mean Residence Time at Steady State (MRTpo,ss)

Mean residence time of empagliflozin (empa) in the body at steady state after multiple oral administrations

Apparent Clearance of Empagliflozin After Extravascular Administration (CL/Fss)

Apparent clearance of empagliflozin (empa) in the plasma at steady state following multiple oral dose administration.

Apparent Volume of Distribution During the Terminal Phase λz (Vz/Fss)

Apparent volume of distribution during the terminal phase λz at steady state following oral administration after multiple dosing

Amount of Analyte Eliminated in Urine at Steady State in Time Interval 0 Hours to 24 Hours (Ae 0-24,ss)

Amount of empagliflozin (empa) eliminated in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.

Fraction of Empagliflozin Excreted Unchanged in Urine at Steady State in the Time Interval 0 Hours to 24 Hours (fe 0-24,ss)

Fraction of empagliflozin (empa) excreted unchanged in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.

Renal Clearance at Steady State (CL R,ss)

Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after multiple dosing.

Accumulation Ratio Based on AUC (R A,AUC)

Accumulation ratio of empagliflozin (empa) based on AUC, after multiple dosing

Accumulation Ratio Based on Cmax (R A,Cmax)

Accumulation ratio of empagliflozin (empa) based on Cmax, after multiple dosing

Predose Plasma Concentration Before Planned Dose x (Cpre,x)

Predose plasma concentration of empagliflozin (empa) before planned dose by day. This endpoint in steady state is identical to Cmin,ss.

Urinary Glucose Excretion (UGE) Change From Baseline

Change from day -1 in urinary glucose excretion in a 24 hour collection period per time point.

Fasting Plasma Glucose (FPG) Change From Baseline

Fasting Plasma Glucose (FPG) change from baseline between day 1 and day 9.

Secondary Outcome Measures

Clinical Relevant Abnormalities for Protocol-Specified Significant Adverse Events, Hypoglycaemic Events, Vital Signs, Blood Chemistry, Rescue Therapy, Body Weight and Waist Circumference

Clinically relevant abnormalities for protocol-specified significant adverse events, hypoglycaemic events, vital signs, blood chemistry, use of rescue therapy, change in body weight and change in waist circumference. Results shown are for hypoglycaemic events, as this was the only event that occurred for this endpoint.

Full Information

NCT ID

NCT01316341

First Posted

March 15, 2011

Last Updated

May 16, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01316341

Brief Title

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus

Official Title

Pharmacokinetics and Pharmacodynamics of BI 10773 After Single and Multiple Oral Dose of 10 mg and 25 mg BI 10773 in Chinese Male and Female Type 2 Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d. administered to Chinese female and male patients with type 2 diabetes will be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BI10773 low dose Per Os(p.o.)

Arm Type

Experimental

Arm Description

patient to receive a tablet containing low dose BI10773 Per Os(p.o.) plus one placebo

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

patient to receive two placebos

Arm Title

BI10773 high dose Per Os(p.o.)

Arm Type

Experimental

Arm Description

patient to receive a tablet containing high dose BI10773 Per Os(p.o.) plus one placebo

Intervention Type

Drug

Intervention Name(s)

BI10773

Intervention Description

patient to receive a tablet containing high dose BI10773 p.o. plus one placebo

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

patient to receive two placebos

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

patient to receive two placebos

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

patient to receive two placebos

Intervention Type

Drug

Intervention Name(s)

BI10773

Intervention Description

patient to receive a tablet containing low dose BI10773 p.o. plus one placebo

Primary Outcome Measure Information:

Title

Maximum Measured Concentration (Cmax)

Description

Maximum measured concentration of the analyte in plasma after the first dose on day 1.

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Time to Maximum Measured Concentration (Tmax)

Description

Time from dosing to the maximum measured concentration of the analyte in plasma, after the first dose on day 1.

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Area Under the Curve 0 to Infinity (AUC0-∞) After Single Dosing

Description

Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity, after the first dose on day 1

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

Description

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, after the first dose on day 1.

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Terminal Rate Constant (λz)

Description

Terminal Rate Constant in Plasma (λz), after the first dose on day 1

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Terminal Half-life (t1/2)

Description

Terminal half-life of empagliflozin (empa) in plasma after the first dose on day 1

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Mean Residence Time (MRTpo)

Description

Mean residence time of empagliflozin (empa) in the body after the first dose on day 1.

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Apparent Clearance of Empagliflozin After Extravascular Administration (CL/F)

Description

Apparent clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Apparent Volume of Distribution During the Terminal Phase λz (Vz/F)

Description

Apparent volume of distribution during the terminal phase λz, after the first dose on day 1.

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Amount of Empagliflozin Eliminated in Urine in the Time Interval 0 Hours to 24 Hours (Ae 0-24)

Description

Amount of empagliflozin (empa) eliminated in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.

Time Frame

Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration

Title

Fraction of Empagliflozin Excreted Unchanged in Urine in the Time Interval 0 Hours to 24 Hours (fe 0-24).

Description

Fraction of empagliflozin (empa) excreted unchanged in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.

Time Frame

Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration

Title

Renal Clearance After Extravascular Administration (CL R,0-48)

Description

Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.

Time Frame

5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration

Title

Maximum Measured Concentration Over a Uniform Dosing Interval (Cmax,ss)

Description

Maximum measured concentration of empagliflozin (empa) in plasma at steady state over a uniform dosing interval.

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9

Title

Time From Last Dosing to Maximum Measured Concentration Over a Uniform Dosing Interval at Steady State (Tmax,ss)

Description

Time from last dosing to maximum measured concentration of empagliflozin (empa) in plasma over a uniform dosing interval at steady state, after multiple dosing.

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9

Title

Area Under the Concentration-time Curve in Plasma at Steady State Over a Uniform Dosing Interval (AUCτ,ss)

Description

Area under the concentration-time curve of empagliflozin (empa) in plasma at steady state over a uniform dosing interval, after multiple dosing

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9

Title

Terminal Rate Constant in Plasma at Steady State (λz,ss)

Description

Terminal rate constant in plasma at steady state, after multiple dosing.

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9

Title

Terminal Half-life in Plasma at Steady State (t1/2,ss)

Description

Terminal half-life of empagliflozin (empa) in plasma at steady state, after multiple dosing.

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9

Title

Mean Residence Time at Steady State (MRTpo,ss)

Description

Mean residence time of empagliflozin (empa) in the body at steady state after multiple oral administrations

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9

Title

Apparent Clearance of Empagliflozin After Extravascular Administration (CL/Fss)

Description

Apparent clearance of empagliflozin (empa) in the plasma at steady state following multiple oral dose administration.

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9

Title

Apparent Volume of Distribution During the Terminal Phase λz (Vz/Fss)

Description

Apparent volume of distribution during the terminal phase λz at steady state following oral administration after multiple dosing

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9

Title

Amount of Analyte Eliminated in Urine at Steady State in Time Interval 0 Hours to 24 Hours (Ae 0-24,ss)

Description

Amount of empagliflozin (empa) eliminated in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.

Time Frame

Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration

Title

Fraction of Empagliflozin Excreted Unchanged in Urine at Steady State in the Time Interval 0 Hours to 24 Hours (fe 0-24,ss)

Description

Fraction of empagliflozin (empa) excreted unchanged in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.

Time Frame

Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration

Title

Renal Clearance at Steady State (CL R,ss)

Description

Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after multiple dosing.

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9

Title

Accumulation Ratio Based on AUC (R A,AUC)

Description

Accumulation ratio of empagliflozin (empa) based on AUC, after multiple dosing

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration on days 1 and 9

Title

Accumulation Ratio Based on Cmax (R A,Cmax)

Description

Accumulation ratio of empagliflozin (empa) based on Cmax, after multiple dosing

Time Frame

5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration between days 5 and 9

Title

Predose Plasma Concentration Before Planned Dose x (Cpre,x)

Description

Predose plasma concentration of empagliflozin (empa) before planned dose by day. This endpoint in steady state is identical to Cmin,ss.

Time Frame

5 minutes before drug administration

Title

Urinary Glucose Excretion (UGE) Change From Baseline

Description

Change from day -1 in urinary glucose excretion in a 24 hour collection period per time point.

Time Frame

Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration

Title

Fasting Plasma Glucose (FPG) Change From Baseline

Description

Fasting Plasma Glucose (FPG) change from baseline between day 1 and day 9.

Time Frame

Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration

Secondary Outcome Measure Information:

Title

Clinical Relevant Abnormalities for Protocol-Specified Significant Adverse Events, Hypoglycaemic Events, Vital Signs, Blood Chemistry, Rescue Therapy, Body Weight and Waist Circumference

Description

Time Frame

Drug administration until end of trial, up to 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Chinese male and 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 thiazolidinediones with at least one agent taken at 50% of its maximum dose or less, unchanged for at least 12 weeks before randomization Glycosylated haemoglobin A1(HbA1c)<=8.5% and >=7.0% at screening,age>=21 and age<=70 years (male and female patients),BMI>=19 and <=40 kg/m2 Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation. Exclusion criteria: Patient who did not discontinue the antidiabetic treatment with insulin or glitazones, DPP-IV at least before 12 weeks before randomization Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast at screening visit Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as: 4 Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot) 5 Renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²) 6 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 7 Neurological disorders (such as epilepsy) or psychiatric disorders 8 Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections) 9 Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder 10. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 11. A marked baseline prolongation of QT/QTc interval (e.g., ECG demonstration of a QTc interval >450 ms ) at screening visit

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1245.44.86001 Boehringer Ingelheim Investigational Site

City

Beijing

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

26101175

Citation

Zhao X, Cui Y, Zhao S, Lang B, Broedl UC, Salsali A, Pinnetti S, Macha S. Pharmacokinetic and Pharmacodynamic Properties and Tolerability of Single- and multiple-dose Once-daily Empagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, in Chinese Patients With Type 2 Diabetes Mellitus. Clin Ther. 2015 Jul 1;37(7):1493-502. doi: 10.1016/j.clinthera.2015.05.001. Epub 2015 Jun 19.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.44_U12-1836-02.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.44_Literature.pdf

Description

Related Info

Learn more about this trial

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus

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