Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- AstraZeneca
- Study ID
- NCT02268214
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin — DRUGTablets
- Placebo for dapagliflozin — DRUGTablets
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
- Nov 11, 2014
- Status verified
- Aug 2018
- Primary completion
- Jan 4, 2017
- Completion
- Aug 25, 2017
Study Design
- Enrollment
- 833 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: DapagliflozinDapagliflozin 5 mg tablet orally, once daily for 52 weeks
- Experimental: Arm B: DapagliflozinDapagliflozin 10 mg tablet orally, once daily for 52 weeks
- Placebo Comparator: Arm C: Placebo for DapagliflozinPlacebo tablet orally, once daily for 52 weeks
Primary Outcome Measure
Adjusted Mean Change in HbA1c From Baseline at Week 24 [ Time Frame: From Baseline to Week 24 ]
Locations (36)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | 72205 | - |
| Research Site | Encino | California | 91436 | - |
| Research Site | La Mesa | California | 91942 | - |
| Research Site | San Diego | California | 92161 | - |
| Research Site | Tarzana | California | 91356 | - |
| Research Site | Torrance | California | 90502 | - |
| Research Site | Aurora | Colorado | 80045 | - |
| Research Site | Denver | Colorado | 80220 | - |
| Research Site | Cooper City | Florida | 33024 | - |
| Research Site | Jacksonville | Florida | 32258 | - |
| Research Site | Miami | Florida | 33136 | - |
| Research Site | Port Orange | Florida | 32127 | - |
| Research Site | Idaho Falls | Idaho | 83404-7596 | - |
| Research Site | Des Moines | Iowa | 50314 | - |
| Research Site | Louisville | Kentucky | 40213 | - |
| Research Site | Portland | Maine | 04101 | - |
| Research Site | Hyattsville | Maryland | 20782 | - |
| Research Site | Rockville | Maryland | 20852 | - |
| Research Site | Kalamazoo | Michigan | 49008 | - |
| Research Site | Minneapolis | Minnesota | 55416 | - |
| Research Site | Chesterfield | Missouri | 63017 | - |
| Research Site | Las Vegas | Nevada | 89148 | - |
| Research Site | Albany | New York | 12206 | - |
| Research Site | Buffalo | New York | 14215 | - |
| Research Site | Asheville | North Carolina | 28803 | - |
| Research Site | Chapel Hill | North Carolina | 27517 | - |
| Research Site | Greenville | North Carolina | 27834 | - |
| Research Site | Morehead City | North Carolina | 28557 | - |
| Research Site | Langhorne | Pennsylvania | 19047 | - |
| Research Site | Kingsport | Tennessee | 37660 | - |
| Research Site | Nashville | Tennessee | 37212 | - |
| Research Site | Amarillo | Texas | 79106 | - |
| Research Site | Dallas | Texas | 75230 | - |
| Research Site | Houston | Texas | 77090 | - |
| Research Site | Salt Lake City | Utah | 84108 | - |
| Research Site | Olympia | Washington | 98502 | - |
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