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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
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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


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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581658


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01581658     History of Changes
Other Study ID Numbers: 1245.53
First Submitted: April 17, 2012
First Posted: April 20, 2012
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: August 14, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs