NCT01581658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 17, 2014

Completed
Last Updated

August 14, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

April 17, 2012

Results QC Date

May 16, 2014

Last Update Submit

July 4, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (4)

BI10773 medium dose group 1

EXPERIMENTAL

BI10773 medium dose tablet single dose group 1

Drug: BI10773

BI10773 medium dose group 2

EXPERIMENTAL

BI10773 medium dose tablet single dose group 2

Drug: BI10773

BI10773 Medium dose group 3

EXPERIMENTAL

BI10773 medium dose tablet single dose group 3

Drug: BI10773

BI10773 Medium dose group 4

EXPERIMENTAL

BI10773 medium dose tablet single dose group 4

Drug: BI10773

Interventions

BI10773DRUG

BI10773 medium dose tablet single dose

BI10773 medium dose group 2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1245.53.001 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, Japan

Location

Related Publications (1)

  • 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.

    PMID: 25199997DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 20, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 14, 2017

Results First Posted

June 17, 2014

Record last verified: 2017-07

Locations

JP(1)