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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BI10773

Study type: Interventional

Funder types: Industry

Identifiers

NCT01581658

1245.53

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

BI10773 medium dose group 1

Experimental group

Description:

BI10773 medium dose tablet single dose group 1

Treatment:

Drug: BI10773

Drug: BI10773

Drug: BI10773

Drug: BI10773

BI10773 medium dose group 2

Experimental group

Description:

BI10773 medium dose tablet single dose group 2

Treatment:

Drug: BI10773

Drug: BI10773

Drug: BI10773

Drug: BI10773

BI10773 Medium dose group 3

Experimental group

Description:

BI10773 medium dose tablet single dose group 3

Treatment:

Drug: BI10773

Drug: BI10773

Drug: BI10773

Drug: BI10773

BI10773 Medium dose group 4

Experimental group

Description:

BI10773 medium dose tablet single dose group 4

Treatment:

Drug: BI10773

Drug: BI10773

Drug: BI10773

Drug: BI10773