| Trial ID: | L5120 |
| Source ID: | NCT00831779
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00831779/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF]), Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period., From Baseline to Week 12 | Secondary: Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF]), Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period., From Baseline to Week 12
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Astra Zeneca, Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
116
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-04
|
| Completion Date: |
2010-08
|
| Results First Posted: |
2017-03-01
|
| Last Update Posted: |
2017-04-24
|
| Locations: |
Va San Diego Healthcare System, San Diego, California, 92161, United States|Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States|Temple University General Clinical Research Center, Philadelphia, Pennsylvania, 19140, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00831779
|
