This study is a multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial to evaluate efficacy and safety of the triple combination therapy of prusogliptin, dapagliflozin and metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
815
Prusogliptin, Dapagliflozin(high dose) and Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose.
Prusogliptin placebo, Dapagliflozin (high dose), Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
No. 896, Zhongshan East Road, High-tech Industrial Development Zone
Shijiazhuang, Hebei, China
Mean change from baseline in HbA1c at Week 24
Time frame: From baseline to week 24
Proportion of participants with HbA1c of ≤6.5% and HbA1c of ≤7% at week 24
Time frame: From baseline to week 24
Relative change from baseline in HbA1c at week 12
Time frame: From baseline to week 12
Relative change from baseline in FPG at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in 2h-PPG at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in weight at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in blood pressure at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in blood lipid level at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in 7-point blood glucose levels and average post-meal blood glucose increments at week 24
Time frame: From baseline to week 24
Proportion of participants who received rescue treatment after 24 weeks of treatment
Time frame: From baseline to week 24
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Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose