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NCT01525225 · ClinicalTrials.gov registry record · Phase 1
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
A Phase 1 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01525225: Clinical Trial Phase 1 study, sponsored by AstraZeneca.
NCT01525225 is a Phase 1 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01525225, a Phase 1 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets
Primary Outcome
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Interventions
- DRUG Saxagliptin
- DRUG Metformin XR
- DRUG Metformin IR
- DRUG Metformin immediate release (IR)
- DRUG Saxagliptin/Metformin XR FDC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
Why NCT01525225 stopped before completion
NCT01525225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Saxagliptin is the first listed.
NCT01525225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01525225 about?
NCT01525225 is a clinical study titled "Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM". The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxaglipt...
What is the current status of trial NCT01525225?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2012-09. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01525225?
The interventions under investigation include: Saxagliptin (DRUG), Metformin XR (DRUG), Metformin IR (DRUG), Metformin immediate release (IR) (DRUG), Saxagliptin/Metformin XR FDC (DRUG).
Who is sponsoring clinical trial NCT01525225?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01525225's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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