Pharmacokinetics and Pharmacodynamics of Empagliflozin( BI 10773 )

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01316341
First received: March 15, 2011
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI10773
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • area under the concentration-time curve of the analyte in plasma over the time interval at t1 to t2 after single dosing and after multiple dosing at the steady state [ Time Frame: 3 weeeks ] [ Designated as safety issue: No ]
  • terminal rate constant in plasma after single dosing and after multiple dosing at the steady state [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • terminal half-life of the analyte in plasma at steady state [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • mean residence time of the analyte in the body after oral administration after single dosing and after multiple single dosing at the state [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • apparent clearance of the analyte in plasma following extravascular administration after single dosing and after multiple dosing at steady state. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • apparent volume of distribution after single dosing and after multiple dosing at the steady state [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • amount of analytes that is eliminated in urine from the time point1 to time point2 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • maximum measured concentration of the analyte in plasma after single dosing and after multiple dosing at the steady state [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • time from (last) dosing to the maximum measured concentration of the analyte in plasma after single dosing and after multiple dosing at the steady state [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • physical examination,vital signs (blood pressure and pulse rate),12-lead electrocardiogram (ECG),clinical laboratory (hematology,clinical and urinalysis), adverse events. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2011
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI10773 low dose Per Os(p.o.)
patient to receive a tablet containing low dose BI10773 Per Os(p.o.) plus one placebo
Drug: Placebo
patient to receive two placebos
Drug: BI10773
patient to receive a tablet containing low dose BI10773 p.o. plus one placebo
Placebo Comparator: Placebo
patient to receive two placebos
Drug: Placebo
patient to receive two placebos
Experimental: BI10773 high dose Per Os(p.o.)
patient to receive a tablet containing high dose BI10773 Per Os(p.o.) plus one placebo
Drug: BI10773
patient to receive a tablet containing high dose BI10773 p.o. plus one placebo
Drug: Placebo
patient to receive two placebos

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. 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
  2. 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
  3. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.

Exclusion criteria:

  1. Patient who did not discontinue the antidiabetic treatment with insulin or glitazones, DPP-IV at least before 12 weeks before randomization
  2. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast at screening visit
  3. 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316341

Locations
China
1245.44.86001 Boehringer Ingelheim Investigational Site
Beijing, China
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01316341     History of Changes
Other Study ID Numbers: 1245.44
Study First Received: March 15, 2011
Last Updated: September 27, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014