Phase 1
N=32
Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01581658 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Change From Baseline in Total Urinary Glucose Excretion (UGE) — 74969.3; 62577.4; 57889.0; 23725.1 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI10773 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Urinary Glucose Excretion (UGE) |
74969.3; 62577.4; 57889.0; 23725.1 | — |
| PRIMARY Area Under the Concentration Time Curve of the Analyte in Plasma |
7480; 9630; 10800; 11400 | — |
| PRIMARY Maximum Concentration |
1050; 984; 971; 990 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01581658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.