Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Part of paid clinical trials in Concord, California.
- Sponsor
- AstraZeneca
- Study ID
- NCT02460978
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin — DRUGTablets
- Placebo for dapagliflozin — OTHERTablets
Study Details
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.
Key Dates
- Start date
- Jul 8, 2015
- Status verified
- Feb 2019
- Primary completion
- Sep 2, 2017
- Completion
- Apr 18, 2018
Study Design
- Enrollment
- 815 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dapagliflozin 5 mgDapagliflozin 5 mg tablet orally, once daily for 52 weeks
- Experimental: Dapagliflozin 10 mgDapagliflozin 10 mg tablet orally, once daily for 52 weeks
- Placebo Comparator: PlaceboPlacebo tablet orally, once daily for 52 weeks
Primary Outcome Measure
Adjusted Mean Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline and 24 weeks ]
Locations (47)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Concord | California | 94520 | - |
| Research Site | Fresno | California | 93720 | - |
| Research Site | Los Angeles | California | 90057 | - |
| Research Site | Orange | California | 92868 | - |
| Research Site | San Mateo | California | 94401 | - |
| Research Site | San Ramon | California | 94583 | - |
| Research Site | Walnut Creek | California | 94598 | - |
| Research Site | Golden | Colorado | 80401 | - |
| Research Site | Newark | Delaware | 19713 | - |
| Research Site | Bradenton | Florida | 34201 | - |
| Research Site | Clearwater | Florida | 33756 | - |
| Research Site | Fort Lauderdale | Florida | 33312 | - |
| Research Site | Jacksonville | Florida | 32216 | - |
| Research Site | Miami | Florida | 33156 | - |
| Research Site | Miami Springs | Florida | 33166 | - |
| Research Site | St. Petersburg | Florida | 33709 | - |
| Research Site | Tampa | Florida | 33634 | - |
| Research Site | Atlanta | Georgia | 30308 | - |
| Research Site | Atlanta | Georgia | 30318 | - |
| Research Site | Roswell | Georgia | 30076 | - |
| Research Site | Chicago | Illinois | 60607 | - |
| Research Site | Chicago | Illinois | 60611 | - |
| Research Site | Des Moines | Iowa | 50314 | - |
| Research Site | Overland Park | Kansas | 66209 | - |
| Research Site | Lexington | Kentucky | 40502 | - |
| Research Site | Lexington | Kentucky | 40503 | - |
| Research Site | Kalamazoo | Michigan | 49008 | - |
| Research Site | Edina | Minnesota | 55435 | - |
| Research Site | Jefferson City | Missouri | 65109 | - |
| Research Site | St Louis | Missouri | 63110 | - |
| Research Site | Reno | Nevada | 89511 | - |
| Research Site | Albuquerque | New Mexico | 87109 | - |
| Research Site | Albany | New York | 12208 | - |
| Research Site | Flushing | New York | 11355 | - |
| Research Site | Mineola | New York | 11501 | - |
| Research Site | New Hyde Park | New York | 11042 | - |
| Research Site | New York | New York | 10029 | - |
| Research Site | Philadelphia | Pennsylvania | 19107-4824 | - |
| Research Site | Amarillo | Texas | 79106 | - |
| Research Site | Austin | Texas | 78731 | - |
| Research Site | Dallas | Texas | 75231 | - |
| Research Site | Edinburg | Texas | 78539 | - |
| Research Site | Mesquite | Texas | 74194 | - |
| Research Site | San Antonio | Texas | 78229 | - |
| Research Site | San Antonio | Texas | 78258 | - |
| Research Site | Bennington | Vermont | 05201 | - |
| Research Site | Federal Way | Washington | 98003 | - |
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