A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.
A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial with a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients aged 10-24 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Dapagliflozin 10 mg tablets administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily, for the 28-week site and subject blinded long term extension.
matching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension.
Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24
Time frame: Baseline to Week 24
Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline to Week 24
Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control
Time frame: Baseline to Week 24
Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24
Time frame: Baseline to Week 24
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Research Site
New Haven, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Gainesville, Florida, United States
Research Site
Homestead, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Boston, Massachusetts, United States
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Buffalo, New York, United States
Research Site
The Bronx, New York, United States
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Columbus, Ohio, United States
Research Site
Philadelphia, Pennsylvania, United States
...and 32 more locations