Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
NCT ID: NCT01581658
Last Updated: 2017-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2012-04-01
2012-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BI10773 medium dose group 1
BI10773 medium dose tablet single dose group 1
BI10773
BI10773 medium dose tablet single dose
BI10773 medium dose group 2
BI10773 medium dose tablet single dose group 2
BI10773
BI10773 medium dose tablet single dose
BI10773 Medium dose group 3
BI10773 medium dose tablet single dose group 3
BI10773
BI10773 medium dose tablet single dose
BI10773 Medium dose group 4
BI10773 medium dose tablet single dose group 4
BI10773
BI10773 medium dose tablet single dose
Interventions
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BI10773
BI10773 medium dose tablet single dose
BI10773
BI10773 medium dose tablet single dose
BI10773
BI10773 medium dose tablet single dose
BI10773
BI10773 medium dose tablet single dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1245.53.001 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, , Japan
Countries
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References
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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.
Other Identifiers
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1245.53
Identifier Type: -
Identifier Source: org_study_id
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