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Clinical Trial Details

Trial ID: L5998
Source ID: NCT02719132
Associated Drug: Dapagliflozin
Title: Effect of DapagliFLOzin on Quality of Life in Patients With Type 2 Diabetes in a Real Clinical PrActice
Acronym: FLORA
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Dapagliflozin|DRUG: Metformin
Outcome Measures: Primary: Composite endpoint including quality of life score, Change in the overall quality of life, obesity-specific quality of life and treatment satisfaction in the course of the therapy by the end of each 24-week treatment period compared to the quality of life, obesity-specific quality of life and treatment satisfaction at baseline., 48 weeks | Secondary: Change in HbA1c level, Change in HbA1c level will be assessed as mean change in the course of the treatment compared to baseline., 48 weeks|Change in body weight, Change in body weight will be assessed as mean change in body weight, mean percentage change in body weight and mean change in body mass index compared to baseline and as proportion of patients with body weight decreased by ≥5% during the treatment phase., 48 weeks|Change in waist circumference, Change in waist circumference will be assessed as mean change and mean percentage change in waist circumference during the treatment phase compared to baseline., 48 weeks|Change in fasting plasma glucose, Change in fasting plasma glucose will be assessed as mean change in fasting plasma glucose during the treatment phase compared to baseline., 48 weeks|Proportion of patients, Proportion of patients who achieved therapeutic glycaemic response (HbA1c ≤7%)., 48 weeks | Other: ECG variables, ECG records including the following variables: heart rate (beats per minute), QT (msec), QTcB (msec), sinus heart rate (yes/no), 48 weeks|number of episodes of hypoglycaemia and ketoacidosis, number of episodes of hypoglycaemia and ketoacidosis, 48 weeks|change in glomerular filtration rate, change in glomerular filtration rate compared to baseline at Screening, 48 weeks|laboratory values changes, laboratory values (ALT, AST, total bilirubin, and creatinine), 48 weeks
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-07
Completion Date: 2017-11
Results First Posted:
Last Update Posted: 2016-05-20
Locations:
URL: https://clinicaltrials.gov/show/NCT02719132