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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01581658
First received: April 17, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: April 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI10773 medium dose
BI10773 medium dose tablet single dose group 1
 Drug: BI10773
BI10773 medium dose tablet single dose
Experimental: BI10773 medium dose
BI10773 medium dose tablet single dose group 2
 Drug: BI10773
BI10773 medium dose tablet single dose
Experimental: BI10773 Medium dose
BI10773 medium dose tablet single dose group 3
 Drug: BI10773
BI10773 medium dose tablet single dose
Experimental: BI10773 Medium dose
BI10773 medium dose tablet single dose group 4
 Drug: BI10773
BI10773 medium dose tablet single dose

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581658

Locations
Japan
1245.53.001 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01581658     History of Changes
Other Study ID Numbers: 1245.53
Study First Received: April 17, 2012
Last Updated: April 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 16, 2013