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
833
Tablets
Tablets
Adjusted Mean Change in HbA1c From Baseline at Week 24
Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model\[RMM\]).
Time frame: From Baseline to Week 24
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model\[RMM\])
Time frame: From Baseline to Week 24
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model\[RMM\])
Time frame: From Baseline to Week 24
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model\[RMM\])
Time frame: From Baseline to Week 24
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model\[RMM\])
Time frame: From Baseline to Week 24
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose \> 70 and \<= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model\[RMM\])
Time frame: From Baseline to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Little Rock, Arkansas, United States
Research Site
Encino, California, United States
Research Site
La Mesa, California, United States
Research Site
San Diego, California, United States
Research Site
Tarzana, California, United States
Research Site
Torrance, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Denver, Colorado, United States
Research Site
Cooper City, Florida, United States
Research Site
Jacksonville, Florida, United States
...and 121 more locations
Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events
Subjects with HbA1c reduction from baseline to week 24 (LOCF) \>= 0.5% and without severe hypoglycemia events
Time frame: From Baseline to Week 24