Clinical trial NCT01525238: PK Study of Dapagliflozin in Pediatric Subjects With T2DM
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2012-02-02
Enrollment: 53
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)

Detailed 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: 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
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: Mean Plasma Half-life (T-HALF) of Dapagliflozin
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin
timeFrame: 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:
measure: Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: 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
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide
timeFrame: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose
measure: Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting
timeFrame: Day 1 (Pre-dose) to Day 2
measure: Mean Change in Fasting Plasma Glucose From Baseline Until Day 2
timeFrame: Day 1 (Pre-dose) to Day 2
measure: Mean Total Amount of Glucose Excreted in Urine Over 24 Hours
timeFrame: Time of dose to 24 hours post-dose, Day 1 to Day 2
measure: Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.
timeFrame: Day 1 to Day 3
measure: Number of Participants With Marked Hematology Laboratory Abnormalities
timeFrame: Day 1 (Pre-dose) to Day 3
measure: Number of Participants With Marked Serum Chemistry Abnormalities
timeFrame: Day 1 (Pre-dose) to Day 3
measure: Number of Participants With Marked Abnormalities in Other Chemistry Testing
timeFrame: Day 1 (Pre-dose) to Day 3
measure: Number of Participants With Marked Urinalysis Abnormalities
timeFrame: Day 1 (Pre-dose) to Day 3
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Children Hospital Of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Orlando
country: United States
facility: Nemours Childrens Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit
state: Kentucky
city: Shreveport
country: United States
facility: Lsuhsc-Shreveport
state: Louisiana
city: Kansas City
country: United States
facility: Childrens Mercy Hospital
state: Missouri
city: Buffalo
country: United States
facility: Women And Children'S Hopsital Of Buffalo
state: New York
city: Toledo
country: United States
facility: Promedica Toledo Children'S Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy Children'S Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children'S Hospital Of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children'S Hospital Of Pittsburgh Of Upmc
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist Le Bonheur Hlthcare
state: Tennessee
city: San Antonio
country: United States
facility: Christus Santa Rosa Childrens Hospital
state: Texas
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Veracruz
country: Mexico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: