Clinical Trial Details
| Trial ID: | L6905 |
| Source ID: | NCT02096705 |
| Associated Drug: | Dapagliflozin |
| Title: | Phase III Insulin Add-On Asia Regional Program - ST |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02096705/results |
| Conditions: | Diabetes |
| Interventions: | DRUG: Dapagliflozin|DRUG: Dapagliflozin Placebo |
| Outcome Measures: | Primary: Adjusted Mean Change in HbA1c From Baseline to Week 24, The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm., Baseline (Day 1) and 24 weeks | Secondary: Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL)., Baseline (Day 1) and 24 weeks|Adjusted Mean Change in Body Weight From Baseline to Week 24, Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg)., Baseline (Day 1) and 24 weeks|Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24, The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU)., Baseline (Day 1) and 24 weeks |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 477 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2014-03-31 |
| Completion Date: | 2016-01-28 |
| Results First Posted: | 2017-03-06 |
| Last Update Posted: | 2017-08-09 |
| Locations: | Local Institution, Beijing, Beijing, 100029, China|Local Institution, Beijing, Beijing, 100700, China|Local Institution, Beijing, Beijing, 100730, China|Local Institution, Guangzhou, Guangdong, 510080, China|Local Institution, Guangzhou, Guangdong, 510120, China|Local Institution, Haerbin, Heilongjiang, 150001, China|Local Institution, Changsha, Hunan, 410000, China|Local Institution, Changsha, Hunan, 410008, China|Local Institution, Nanjing, Jiangsu, 210012, China|Local Institution, Suzhou, Jiangsu, 215004, China|Local Institution, Wuxi, Jiangsu, 214023, China|Local Institution, Changchun, Jilin, 130041, China|Local Institution, Shanghai, Shanghai, 200040, China|Local Institution, Shanghai, Shanghai, 200072, China|Local Institution, Shanghai, Shanghai, 200080, China|Local Institution, Shanghai, Shanghai, 200092, China|Local Institution, Xi An, Shanxi, 710032, China|Local Institution, Xi'an, Shanxi, 710061, China|Local Institution, Chengdu, Sichuan, 610072, China|Local Institution, Chongqing, Sichuan, 400010, China|Local Institution, Beijing, 100039, China|Local Institution, Tianjin, China|Local Institution, Busan, 49241, Korea, Republic of|Local Institution, Daegu, 42415, Korea, Republic of|Local Institution, Daejeon, 35233, Korea, Republic of|Local Institution, Seoul, 06351, Korea, Republic of|Local Institution, Seoul, 134-727, Korea, Republic of|Local Institution, Singapore, 169856, Singapore|Local Institution, Singapore, 529889, Singapore |
| URL: | https://clinicaltrials.gov/show/NCT02096705 |
