Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Boehringer Ingelheim
Study ID
NCT02121483
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.

Key Dates

Start date
Jun 30, 2014
Status verified
Jul 2016
Primary completion
Feb 29, 2016
Completion
Feb 29, 2016

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: empagliflozin high dose
    Patient to receive a high dose of empagliflozin
  • Experimental: empagliflozin medium dose
    Patient to receive a medium dose of empagliflozin
  • Experimental: empagliflozin low dose
    Patient to receive a low dose of empagliflozin

Primary Outcome Measure

AUC0-inf [ Time Frame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. ]

Locations (5)

FacilityCityStateZIPSite coordinators
1245.87.01013 Boehringer Ingelheim Investigational SiteNew HavenConnecticut--
1245.87.01004 Boehringer Ingelheim Investigational SiteBostonMassachusetts--
1245.87.01002 Boehringer Ingelheim Investigational SiteToledoOhio--
1245.87.01012 Boehringer Ingelheim Investigational SitePhiladelphiaPennsylvania--
1245.87.01001 Boehringer Ingelheim Investigational SitePittsburghPennsylvania--

Find similar trials in New Haven, CT

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
1245.87.01013 Boehringer Ingelheim Investigational Site· New Haven, CT1245.87.01004 Boehringer Ingelheim Investigational Site· Boston, MA1245.87.01002 Boehringer Ingelheim Investigational Site· Toledo, OH1245.87.01012 Boehringer Ingelheim Investigational Site· Philadelphia, PA1245.87.01001 Boehringer Ingelheim Investigational Site· Pittsburgh, PA

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