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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581658
First Posted: April 20, 2012
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
April 17, 2012
April 20, 2012
May 16, 2014
June 17, 2014
August 14, 2017
April 1, 2012
November 1, 2012   (Final data collection date for primary outcome measure)
  • Change From Baseline in Total Urinary Glucose Excretion (UGE) [ Time Frame: baseline and 24 hours ]
    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 ]
    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 ]
    Maximum concentration of the analyte in plasma
  • Change From Baseline in Total Urinary Glucose Excretion (UGE) [ Time Frame: from baseline to 24 hours ]
  • 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 ]
  • maximum concentration of the analyte in plasma [ Time Frame: up to 96 hours ]
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: BI10773
BI10773 medium dose tablet single dose
  • Experimental: BI10773 medium dose group 1
    BI10773 medium dose tablet single dose group 1
    Intervention: Drug: BI10773
  • Experimental: BI10773 medium dose group 2
    BI10773 medium dose tablet single dose group 2
    Intervention: Drug: BI10773
  • Experimental: BI10773 Medium dose group 3
    BI10773 medium dose tablet single dose group 3
    Intervention: Drug: BI10773
  • Experimental: BI10773 Medium dose group 4
    BI10773 medium dose tablet single dose group 4
    Intervention: Drug: BI10773
Sarashina A, Ueki K, Sasaki T, Tanaka Y, Koiwai K, Sakamoto W, Woerle HJ, Salsali A, Broedl UC, Macha S. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus. Clin Ther. 2014 Nov 1;36(11):1606-15. doi: 10.1016/j.clinthera.2014.08.001. Epub 2014 Sep 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 1, 2012
November 1, 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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01581658
1245.53
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2017

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