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Clinical Trial Details

Trial ID: L7086
Source ID: NCT02157298
Associated Drug: Dapagliflozin 5 Mg
Title: Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin.
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02157298/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin 5 mg|DRUG: Placebo tablet
Outcome Measures: Primary: Adjusted Mean Change in HbA1c Levels, Mean change in HbA1c levels from baseline to Week 16 between dapagliflozin 5 mg versus placebo, Baseline to Week 16 | Secondary: Fasting Plasma Glucose, Mean change in fasting plasma glucose from baseline to Week 16 between dapagliflozin 5 mg versus placebo, Baseline to Week 16|Total Body Weight, Mean change in total body weight from baseline to Week 16 between dapagliflozin 5 mg versus placebo, Baseline to Week 16|Total Mean Daily Insulin Dose, Mean change in calculated mean daily insulin dose from baseline to Week 16 between dapagliflozin 5 mg versus placebo, Baseline to Week 16|Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10%, Proportion of participants with mean daily insulin dose reduction greater than or equal 10% from baseline to week 16 (LOCF) between dapagliflozin 5 mg versus placebo, Baseline to Week 16
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 266
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-06
Completion Date: 2015-11
Results First Posted: 2016-03-17
Last Update Posted: 2016-05-11
Locations: Research Site, Adachi-ku, Japan|Research Site, Chitose-shi, Japan|Research Site, Chiyoda-ku, Japan|Research Site, Chuo-ku, Japan|Research Site, Fukuoka-shi, Japan|Research Site, Hirosaki-shi, Japan|Research Site, Kamakura-shi, Japan|Research Site, Koriyama-shi, Japan|Research Site, Mitaka-shi, Japan|Research Site, Oita-Shi, Japan|Research Site, Osaka-shi, Japan|Research Site, Sendai-shi, Japan|Research Site, Shizuoka-shi, Japan|Research Site, Yokohama-shi, Japan
URL: https://clinicaltrials.gov/show/NCT02157298

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