Clinical Trial Details
| Trial ID: | L4658 |
| Source ID: | NCT01294423 |
| Associated Drug: | Dapagliflozin |
| Title: | Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01294423/results |
| Conditions: | Type 2 Diabetes|High Blood Sugar |
| Interventions: | DRUG: Dapagliflozin|DRUG: Dapagliflozin|DRUG: Placebo |
| Outcome Measures: | Primary: Adjusted Mean Change in HbA1c Levels, To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment., From Baseline to Week 24 | Secondary: Adjusted Mean Change in Fasting Plasma Glucose (FPG), To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment., From Baseline to Week 24|Adjusted Mean Change in Body Weight, To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment., From Baseline to Week 24 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 261 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2011-02 |
| Completion Date: | 2012-03 |
| Results First Posted: | 2013-08-23 |
| Last Update Posted: | 2014-07-24 |
| Locations: | Research Site, Noda, Chiba, Japan|Research Site, Yukuhashi, Fukuoka, Japan|Research Site, Hiroshima-shi, Hiroshima, Japan|Research Site, Chitose-shi, Hokkaido, Japan|Research Site, Sapporo, Hokkaido, Japan|Research Site, Takasago-shi, Hyogo, Japan|Research Site, Hakusan-shi, Ishikawa, Japan|Research Site, Sanuki-shi, Kagawa, Japan|Research Site, Takamatsu-shi, Kagawa, Japan|Research Site, Ebina-shi, Kanagawa, Japan|Research Site, Kamakura-shi, Kanagawa, Japan|Research Site, Sendai-shi, Miyagi, Japan|Research Site, Sendai, Miyagi, Japan|Research Site, Matsumoto-shi, Nagano, Japan|Research Site, Osaka-shi, Osaka, Japan|Research Site, Suita, Osaka, Japan|Research Site, Otsu-shi, Shiga, Japan|Research Site, Shizuoka-shi, Shizuoka, Japan|Research Site, Chuo-ku, Tokyo, Japan|Research Site, Chuo, Tokyo, Japan|Research Site, Meguro-ku,, Tokyo, Japan|Research Site, Ota-ku, Tokyo, Japan|Research Site, Takaoka-shi, Toyama, Japan|Research Site, Toyama-shi, Toyama, Japan|Research Site, Fukuoka, Japan|Research Site, Okayama, Japan|Research Site, Tokyo, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01294423 |
