The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
905
5mg, orally, Green, plain, diamond-shaped, film-coated tablet
Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet
5mg, orally, Plain, yellow, biconvex, round, film-coated tablet
Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet
Research Site
Saraland, Alabama, United States
Research Site
Fresno, California, United States
Research Site
Harbor City, California, United States
Research Site
Hawaiian Gardens, California, United States
Research Site
Lancaster, California, United States
Research Site
Change From Baseline in HbA1c at Week 24
To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set. Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication.
Time frame: Baseline and week 24
Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks
To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually on proportion of participants achieving therapeutic glycaemic response after 24 weeks. Therapeutic glycaemic response was defined as an HbA1c value at Week 24 \<7.0% irrespective of whether participant received rescue medication. Risk difference for each treatment was calculated as adjusted response rate. Participants who did not had an HbA1c measurement at Week 24 were regarded as non-responders. Results were presented for the modified full analysis set.
Time frame: Baseline and week 24
Change in Fasting Plasma Glucose at 24 Weeks
To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5mg to either agent individually on fasting plasma glucose after 24 weeks. Results were presented for the modified full analysis set.
Time frame: Baseline and week 24
Change in Total Body Weight at 24 Weeks
To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to saxagliptin 5 mg on total body weight after 24 weeks. Results were presented for the modified full analysis set.
Time frame: Baseline and week 24
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Los Angeles, California, United States
Research Site
Montclair, California, United States
Research Site
Pomona, California, United States
Research Site
Spring Valley, California, United States
Research Site
Vallejo, California, United States
...and 100 more locations