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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581658
• Other study ID #: 1245.53
• Status: Completed
• Phase: Phase 1
• First received: April 17, 2012
• Last updated: May 16, 2014
• Start date: April 2012
• Est. completion date: November 2012

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Renal Insufficiency

Intervention

Drug:
• BI10773
BI10773 medium dose tablet single dose
• BI10773
BI10773 medium dose tablet single dose

Locations

Country	Name	City	State
Japan	1245.53.001 Boehringer Ingelheim Investigational Site	Kurume, Fukuoka

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Urinary Glucose Excretion (UGE)	change from baseline in total urinary glucose excretion (UGE) to 24 hours	baseline and 24 hours	No
Primary	Area Under the Concentration Time Curve of the Analyte in Plasma	Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity	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	No
Primary	Maximum Concentration	Maximum concentration of the analyte in plasma	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	No

External Links

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