Clinical Trial Details
| Trial ID: | L4305 |
| Source ID: | NCT02429258 |
| Associated Drug: | Farxiga |
| Title: | Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02429258/results |
| Conditions: | Type II Diabetes |
| Interventions: | DRUG: Farxiga|DRUG: Placebo|DRUG: Metformin|DRUG: Insulin |
| Outcome Measures: | Primary: Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System, Baseline to Week 4 | Secondary: Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4, Baseline to Week 4|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population, Baseline to Week 4|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population, Baseline to Week 4|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population, Baseline to Week 4|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4, Baseline to Week 4|Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4, Baseline to Week 4|Change in HbA1c From Baseline to Week 4, Baseline to Week 4|Change in Fructosamine From Baseline to Week 4, Baseline to Week 4|Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4, Baseline to Week 4|Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population, Baseline to Week 4 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 226 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-05 |
| Completion Date: | 2015-10 |
| Results First Posted: | 2017-04-11 |
| Last Update Posted: | 2017-06-14 |
| Locations: | Research Site, Birmingham, Alabama, United States|Research Site, Phoenix, Arizona, United States|Research Site, Huntington Park, California, United States|Research Site, Los Angeles, California, United States|Research Site, Sacramento, California, United States|Research Site, San Diego, California, United States|Research Site, West Hills, California, United States|Research Site, Cooper City, Florida, United States|Research Site, Miami, Florida, United States|Research Site, Evanston, Illinois, United States|Research Site, Oxon Hill, Maryland, United States|Research Site, Henderson, Nebraska, United States|Research Site, Brooklyn, New York, United States|Research Site, Rochester, New York, United States|Research Site, Greensboro, North Carolina, United States|Research Site, Cincinnati, Ohio, United States|Research Site, Dublin, Ohio, United States|Research Site, Franklin, Ohio, United States|Research Site, Eugene, Oregon, United States|Research Site, Lansdale, Pennsylvania, United States|Research Site, Spartanburg, South Carolina, United States|Research Site, Bartlett, Tennessee, United States|Research Site, Dallas, Texas, United States|Research Site, Houston, Texas, United States|Research Site, Hurst, Texas, United States|Research Site, Renton, Washington, United States |
| URL: | https://clinicaltrials.gov/show/NCT02429258 |
