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
Public ClinicalTrials.gov record NCT03199053. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients With Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03199053
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 256 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 11, 2017 (Actual)
- Primary completion
- Feb 1, 2023 (Actual)
- Completion
- Jan 3, 2024 (Actual)
- Last update posted
- Jun 21, 2024
2017 – 2024
United States locations
- U.S. sites
- 20
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Sacramento | California | 95821 | — |
| Research Site | New Haven | Connecticut | 06519 | — |
| Research Site | Hialeah | Florida | 33012 | — |
| Research Site | Hialeah | Florida | 33016 | — |
| Research Site | Hollywood | Florida | 33021 | — |
| Research Site | Miami | Florida | 33144 | — |
| Research Site | Miami | Florida | 33155 | — |
| Research Site | Miami | Florida | 33165 | — |
| Research Site | Miami Springs | Florida | 33166 | — |
| Research Site | Atlanta | Georgia | 30322 | — |
| Research Site | Atlanta | Georgia | 30341 | — |
| Research Site | Idaho Falls | Idaho | 83404 | — |
| Research Site | Neptune City | New Jersey | 07753 | — |
| Research Site | Memphis | Tennessee | 38116 | — |
| Research Site | Memphis | Tennessee | 38119 | — |
| Research Site | Edinburg | Texas | 78539 | — |
| Research Site | Harlingen | Texas | 78550 | — |
| Research Site | McAllen | Texas | 78503 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 102 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03199053, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2024 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03199053 live on ClinicalTrials.gov.