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NCT03199053 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 256
- Enrollment target
NCT03199053: Completed Phase 3 study, sponsored by AstraZeneca.
NCT03199053 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 256 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03199053, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 256 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine if there will be a greater mean reduction from baseline in glycated hemoglobin (HbA1c) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin or saxagliptin compared to placebo in paediatric T2DM patients with HbA1c levels of 6.5 to 10.5% on diet and exercise and metformin, insulin, or metformin plus insulin.
Primary Outcome
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on multiple imputation washout (MI-WO) within each arm using the data from placebo participants with Week 26 data.
Interventions
- DRUG Placebo
- DRUG Dapagliflozin
- DRUG Saxagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2024-01-03 |
| Phase | Phase 3 |
What the finished NCT03199053 record still lists
NCT03199053 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03199053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03199053 about?
NCT03199053 is a clinical study titled "Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old". The primary objective of this study is to determine if there will be a greater mean reduction from baseline in glycated hemoglobin (HbA1c) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin or saxagliptin compared to placebo in paediatric T2DM patients with HbA1c levels of ...
What is the current status of trial NCT03199053?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 2017-10-11. Estimated completion is 2024-01-03.
What interventions are being tested in trial NCT03199053?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin (DRUG), Saxagliptin (DRUG).
Who is sponsoring clinical trial NCT03199053?
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 NCT03199053's enrollment target sits among peer trials
256 1240th of 2000 higher than 759 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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