Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01581658
First received: April 17, 2012
Last updated: May 16, 2014
Last verified: May 2014

April 17, 2012
May 16, 2014
April 2012
November 2012   (final data collection date for primary outcome measure)
  • Change From Baseline in Total Urinary Glucose Excretion (UGE) [ Time Frame: baseline and 24 hours ] [ Designated as safety issue: No ]
    change from baseline in total urinary glucose excretion (UGE) to 24 hours
  • Area Under the Concentration Time Curve of the Analyte in Plasma [ Time Frame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration ] [ Designated as safety issue: No ]
    Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity
  • Maximum Concentration [ Time Frame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration ] [ Designated as safety issue: No ]
    Maximum concentration of the analyte in plasma
  • change from baseline in total urinary glucose excretion (UGE) [ Time Frame: from baseline to 24 hours ] [ Designated as safety issue: No ]
  • area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
  • maximum concentration of the analyte in plasma [ Time Frame: up to 96 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01581658 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
A Phase I, Open-label, Parallel-group Study to Investigate Pharmacokinetics, Pharmacodynamics and Safety of a Single 25 mg Dose of Empagliflozin in Japanese Type 2 Diabetes Patients With Different Degrees of Renal Impairment in Comparison to Type 2 Diabetes Patients With Normal Renal Function

The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: BI10773
BI10773 medium dose tablet single dose
  • Experimental: BI10773 medium dose
    BI10773 medium dose tablet single dose group 1
    Intervention: Drug: BI10773
  • Experimental: BI10773 medium dose
    BI10773 medium dose tablet single dose group 2
    Intervention: Drug: BI10773
  • Experimental: BI10773 Medium dose
    BI10773 medium dose tablet single dose group 3
    Intervention: Drug: BI10773
  • Experimental: BI10773 Medium dose
    BI10773 medium dose tablet single dose group 4
    Intervention: Drug: BI10773
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Type 2 diabetes patients
  • Glycosylated haemoglobin>= 6.1% (Japan Diabetes Society)
  • Estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of >= 15 mL/min/1.73m2

Exclusion criteria:

  • Any evidence of significant disease (other than renal impairment)
  • Moderate and severe concurrent liver function impairment
  • Gastrointestinal tract surgery, that might affect absorption and elimination of drugs
  • Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
  • Chronic or relevant acute infections
  • Participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01581658
1245.53
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP