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NCT01525238 · ClinicalTrials.gov registry record · Phase 1

PK Study of Dapagliflozin in Pediatric Subjects With T2DM

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
53
Enrollment target

NCT01525238: Completed Phase 1 study, sponsored by AstraZeneca.

NCT01525238 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01525238, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
53 participants
Enrollment target

Study Summary

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

Primary Outcome

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).

Interventions

  • DRUG Dapagliflozin

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2012-07-01
Est. Completion 2014-09-01
Phase Phase 1
AstraZeneca

1,285 total trials

What the finished NCT01525238 record still lists

NCT01525238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).

The record links to 0 conditions, and to 1 intervention - of which Dapagliflozin is the first listed.

NCT01525238 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01525238 about?

NCT01525238 is a clinical study titled "PK Study of Dapagliflozin in Pediatric Subjects With T2DM". The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)

What is the current status of trial NCT01525238?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2012-07-01. Estimated completion is 2014-09-01.

What interventions are being tested in trial NCT01525238?

The interventions under investigation include: Dapagliflozin (DRUG).

Who is sponsoring clinical trial NCT01525238?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01525238's enrollment target sits among peer trials

53 948th of 2000 higher than 1,045 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01525238, the US trial registry maintained by the National Library of Medicine. NCT01525238 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.