PK Study of Dapagliflozin in Pediatric Subjects With T2DM

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525238
• Other study ID #: MB102-091
• Secondary ID: 2011-005225-40
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2012
• Last updated: February 6, 2015
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Primary purpose: The primary purpose is to assess the pharmacokinetics of a single dose of Dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with T2DM

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of T2DM

• Male and female subjects ages 10-17

• Glycosylated Hemoglobin A1c (HbA1c) >6 to <10%

Exclusion Criteria:

• Fasting plasma glucose (FPG) >240 mg/dL at screening

• Abnormal renal function

• Active liver disease and/or significant abnormal liver function

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Tablet, Oral, 2.5 mg, Single-dose
• Dapagliflozin
Tablet, Oral, 5 mg, Single-dose
• Dapagliflozin
Tablet, Oral, 10 mg, Single-dose

Locations

Country	Name	City	State
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Veracruz
United States	Emory University	Atlanta	Georgia
United States	The Children Hospital Of Alabama	Birmingham	Alabama
United States	Women And Children'S Hopsital Of Buffalo	Buffalo	New York
United States	Childrens Mercy Hospital	Kansas City	Missouri
United States	Axis Clinical Trials	Los Angeles	California
United States	Kosair Charities Pediatric Clinical Research Unit	Louisville	Kentucky
United States	Methodist Le Bonheur Hlthcare	Memphis	Tennessee
United States	Nemours Childrens Hospital	Orlando	Florida
United States	Children'S Hospital Of Philadelphia	Philadelphia	Pennsylvania
United States	Children'S Hospital Of Pittsburgh Of Upmc	Pittsburgh	Pennsylvania
United States	Christus Santa Rosa Childrens Hospital	San Antonio	Texas
United States	Lsuhsc-Shreveport	Shreveport	Louisiana
United States	Mercy Children'S Hospital	Toledo	Ohio
United States	Promedica Toledo Children'S Hospital	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	AstraZeneca

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of Dapagliflozin derived from plasma concentration versus time		11 time points up to Day 3	No
Primary	Time of maximum observed plasma concentration (Tmax) of Dapagliflozin derived from plasma concentration versus time		11 time points up to Day 3	No
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Dapagliflozin derived from plasma concentration versus time		11 time points up to Day 3	No
Primary	Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Dapagliflozin derived from plasma concentration versus time		11 time points up to Day 3	No
Primary	Plasma half-life (T-HALF) of Dapagliflozin derived from plasma concentration versus time		11 time points up to Day 3	No
Primary	Apparent clearance after extravascular administration (CL/F) of Dapagliflozin derived from plasma concentration versus time		11 time points up to Day 3	No
Primary	Apparent volume of distribution at terminal phase after extravascular administration (Vz/F) of Dapagliflozin derived from plasma concentration versus time		11 time points up to Day 3	No
Secondary	Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs) and clinical laboratory tests		Up to Day 3	Yes
Secondary	Maximum observed plasma concentration (Cmax) of Dapagliflozin 3-O-Glucuronide		11 time points up to Day 3	No
Secondary	Time of maximum observed plasma concentration (Tmax) of Dapagliflozin 3-O-Glucuronide		11 time points up to Day 3	No
Secondary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide		11 time points up to Day 3	No
Secondary	Area under the plasma 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 up to Day 3	No
Secondary	Plasma half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide		11 time points up to Day 3	No
Secondary	Fasting plasma glucose concentration		At pre-dose on Day 1 and Day 2 after an 8-hr fasting	No
Secondary	Urinary glucose amounts		First 24 h after Dapagliflozin administration	No

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