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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 256 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03199053
The ClinicalTrials.gov registry entry for NCT03199053 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03199053 reports 0 study locations.
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.
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