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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Empagliflozin

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