Phase 1 Completed N=24 Randomized Other

PK Study of Dapagliflozin in Pediatric Subjects With T2DM

Source: ClinicalTrials.gov NCT01525238 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcomePrimary: Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin — 24.8; 48.4; 118 ng/mL

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin	24.8; 48.4; 118	—
PRIMARY Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin	1.50; 0.960; 0.875	—
PRIMARY Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin	101; 199; 427	—
PRIMARY 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	92.3; 189; 418	—
PRIMARY Mean Plasma Half-life (T-HALF) of Dapagliflozin	14.1; 10.3; 10.7	—
PRIMARY Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin	413; 418; 391	—
PRIMARY Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin	468; 343; 355	—
SECONDARY Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide	24.6; 49.0; 154	—
SECONDARY Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide	1.50; 1.50; 1.50	—
SECONDARY Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide	105; 232; 658	—
SECONDARY 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	95.8; 208; 612	—
SECONDARY Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide	4.62; 8.71; 8.37	—
SECONDARY Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting	146.2; 152.1; 139.8; 124.0; 119.4; 119.0	—
SECONDARY Mean Change in Fasting Plasma Glucose From Baseline Until Day 2	-46.7; -32.8; -22.0	—
SECONDARY Mean Total Amount of Glucose Excreted in Urine Over 24 Hours	52.84; 62.39; 89.04	—
SECONDARY Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Marked Hematology Laboratory Abnormalities	1; 0; 1; 0; 0; 1	—
SECONDARY Number of Participants With Marked Serum Chemistry Abnormalities	1; 0; 0; 1; 0; 0	—
SECONDARY Number of Participants With Marked Abnormalities in Other Chemistry Testing	1; 1; 0; 0; 0; 0	—
SECONDARY Number of Participants With Marked Urinalysis Abnormalities	0; 0; 2; 2; 3; 4	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01525238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.