NCT01525238

Brief Summary

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
2 countries

17 active sites

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

First Submitted

Initial submission to the registry

January 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 21, 2016

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

January 31, 2012

Results QC Date

September 29, 2016

Last Update Submit

April 26, 2017

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (7)

  • Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin

    Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL).

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin

    Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h).

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin

    Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng\*hr/mL).

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin

    Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng\*h/mL).

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Mean Plasma Half-life (T-HALF) of Dapagliflozin

    Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours.

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin

    Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min).

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin

    Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L)

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Secondary Outcomes (13)

  • Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide

    11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

  • +8 more secondary outcomes

Study Arms (3)

Dapagliflozin 2.5 mg

EXPERIMENTAL
Drug: Dapagliflozin

Dapagliflozin 5 mg

EXPERIMENTAL
Drug: Dapagliflozin

Dapagliflozin 10 mg

EXPERIMENTAL
Drug: Dapagliflozin

Interventions

DapagliflozinDRUG

Tablet, Oral, 2.5 mg, Single-dose

Dapagliflozin 2.5 mg

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of T2DM
  • Male and female subjects ages 10-17
  • Glycosylated Hemoglobin A1c (HbA1c) ≥6 to 10%
  • Body weight ≥30 kg

You may not qualify if:

  • Fasting plasma glucose (FPG) \>240 mg/dL at screening
  • Abnormal renal function
  • Active liver disease and/or significant abnormal liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

The Children Hospital Of Alabama

Birmingham, Alabama, 35233, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Nemours Childrens Hospital

Orlando, Florida, 32827, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, 40202, United States

Location

Lsuhsc-Shreveport

Shreveport, Louisiana, 71103, United States

Location

Childrens Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Women And Children'S Hopsital Of Buffalo

Buffalo, New York, 14222, United States

Location

Promedica Toledo Children'S Hospital

Toledo, Ohio, 43606, United States

Location

Mercy Children'S Hospital

Toledo, Ohio, 43608, United States

Location

Children'S Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children'S Hospital Of Pittsburgh Of Upmc

Pittsburgh, Pennsylvania, 15224, United States

Location

Methodist Le Bonheur Hlthcare

Memphis, Tennessee, 38103, United States

Location

Christus Santa Rosa Childrens Hospital

San Antonio, Texas, 78207, United States

Location

Local Institution

Guadalajara, Jalisco, 44150, Mexico

Location

Local Institution

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution

Veracruz, 91910, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Anna Maria Langkilde
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 2, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 30, 2017

Results First Posted

November 21, 2016

Record last verified: 2017-04

Locations

US(14)ME(3)