This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,240
tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Adjusted Mean Change in HbA1c Levels
To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.
Time frame: Baseline to Week 24
Adjusted Mean Change in Body Weight
To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration.
Time frame: Baseline to Week 24
Adjusted Mean Change in Calculated Mean Daily Insulin Dose
To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration.
Time frame: Baseline to Week 24
Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction
To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction \>= 10%) as compared to placebo added to insulin treatment.
Time frame: Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration.
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Placebo
tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg
Research Site
Fresno, California, United States
Research Site
Greenbrae, California, United States
Research Site
Roswell, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Omaha, Nebraska, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Corpus Christi, Texas, United States
Research Site
Dallas, Texas, United States
...and 82 more locations
Time frame: Baseline to Week 24