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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
BI10773
BI10773
BI10773
BI10773
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 1245.53.001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BI10773 medium dose group 1

BI10773 medium dose group 2

BI10773 Medium dose group 3

BI10773 Medium dose group 4

Arm Description

BI10773 medium dose tablet single dose group 1

BI10773 medium dose tablet single dose group 2

BI10773 medium dose tablet single dose group 3

BI10773 medium dose tablet single dose group 4

Outcomes

Primary Outcome Measures

Change From Baseline in Total Urinary Glucose Excretion (UGE)
change from baseline in total urinary glucose excretion (UGE) to 24 hours
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
Maximum Concentration
Maximum concentration of the analyte in plasma

Secondary Outcome Measures

Full Information

First Posted
April 17, 2012
Last Updated
July 4, 2017
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01581658
Brief Title
Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2012 (Actual)
Primary Completion Date
November 1, 2012 (Actual)
Study Completion Date
November 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI10773 medium dose group 1
Arm Type
Experimental
Arm Description
BI10773 medium dose tablet single dose group 1
Arm Title
BI10773 medium dose group 2
Arm Type
Experimental
Arm Description
BI10773 medium dose tablet single dose group 2
Arm Title
BI10773 Medium dose group 3
Arm Type
Experimental
Arm Description
BI10773 medium dose tablet single dose group 3
Arm Title
BI10773 Medium dose group 4
Arm Type
Experimental
Arm Description
BI10773 medium dose tablet single dose group 4
Intervention Type
Drug
Intervention Name(s)
BI10773
Intervention Description
BI10773 medium dose tablet single dose
Intervention Type
Drug
Intervention Name(s)
BI10773
Intervention Description
BI10773 medium dose tablet single dose
Intervention Type
Drug
Intervention Name(s)
BI10773
Intervention Description
BI10773 medium dose tablet single dose
Intervention Type
Drug
Intervention Name(s)
BI10773
Intervention Description
BI10773 medium dose tablet single dose
Primary Outcome Measure Information:
Title
Change From Baseline in Total Urinary Glucose Excretion (UGE)
Description
change from baseline in total urinary glucose excretion (UGE) to 24 hours
Time Frame
baseline and 24 hours
Title
Area Under the Concentration Time Curve of the Analyte in Plasma
Description
Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity
Time Frame
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
Title
Maximum Concentration
Description
Maximum concentration of the analyte in plasma
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1245.53.001 Boehringer Ingelheim Investigational Site
City
Kurume, Fukuoka
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25199997
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.53_U13-1584-01-DS.pdf
Description
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Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes

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