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

NCT01907113 | Completed Phase 1 Results

• 2 other identifiers: 1245.122008-006086-86
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  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

  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

  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

  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

  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

Study Arms (5)

BI 10773 / Group 2

EXPERIMENTAL

Single Dose Administration (type 2 diabetes and mild renal impairment)

Drug: BI 10773

BI 10773 / Group 3

EXPERIMENTAL

Single Dose Administration (type 2 diabetes and moderate renal impairment)

Drug: BI 10773

BI 10773 / Group 4

EXPERIMENTAL

Single Dose Administration (severe renal impairment 8)

Drug: BI 10773

BI 10773 / Group 5

EXPERIMENTAL

Single Dose Administration (kidney failure)

Drug: BI 10773

BI 10773 / Group 1

EXPERIMENTAL

Single Dose Administration (type 2 diabetes and normal renal function)

Drug: BI 10773

Interventions

BI 10773 DRUG

oral administration

BI 10773 / Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1245.12.1 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

1245.12.2 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 24, 2013
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 14, 2014
• Results First Posted: July 14, 2014

Record last verified: 2014-07

Locations

DE (2)