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Clinical Trial Details

Trial ID: L2695
Source ID: NCT00972244
Associated Drug: Dapagliflozin
Title: Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00972244/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: Primary: Adjusted Mean Change in HbA1c Levels, The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available., Baseline to Week 12 | Secondary: Adjusted Mean Change in Fasting Plasma Glucose, Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available., Baseline to Week 12|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%, Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin \<7%, after 12 weeks of double-blind therapy, At Week 12
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 417
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-08
Completion Date: 2010-05
Results First Posted: 2013-10-14
Last Update Posted: 2013-10-14
Locations: Research Site, Anjyo, Japan|Research Site, Bunkyo-ku, Japan|Research Site, Chuo-ku, Japan|Research Site, Daito, Japan|Research Site, Kamagaya, Japan|Research Site, Kashiwara, Japan|Research Site, Matsuyama, Japan|Research Site, Nagoya, Japan|Research Site, Nakano-ku, Japan|Research Site, Naka, Japan|Research Site, Nerima-ku, Japan|Research Site, Okinawa, Japan|Research Site, Osaka, Japan|Research Site, Sapporo, Japan|Research Site, Shibuya-ku, Japan|Research Site, Shinjyuku-ku, Japan|Research Site, Suita, Japan|Research Site, Uji, Japan|Research Site, Wakayama, Japan|Research Site, Yamato, Japan
URL: https://clinicaltrials.gov/show/NCT00972244

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details