The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
815
Tablets
Tablets
Adjusted Mean Change From Baseline in HbA1c at Week 24
To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time frame: Baseline and 24 weeks
Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24
To compare the percent change from baseline in total daily insulin dose with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time frame: Baseline and 24 weeks
Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24
To compare the percentage change from baseline in body weight with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time frame: Baseline and 24 weeks
Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24
To compare the change from baseline in mean value of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time frame: Baseline and 24 weeks
Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24
To compare the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time frame: Baseline and 24 weeks
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Research Site
Concord, California, United States
Research Site
Fresno, California, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
San Mateo, California, United States
Research Site
San Ramon, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Golden, Colorado, United States
Research Site
Newark, Delaware, United States
Research Site
Bradenton, Florida, United States
...and 126 more locations
Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24
To compare the change from baseline in the percent of 24-hour glucose readings obtained from CGM that falls within the target range of \>70 mg/dL and \<=180 mg/dL with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment
Time frame: Baseline and 24 weeks
Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24
To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the proportion of subjects achieving an HbA1c reduction from baseline to Week 24 visit \>=0.5% without severe hypoglycemia events
Time frame: Baseline and 24 weeks