This study is designed to evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to 24 weeks after the combination therapy of cofrogliptin, metformin and SGLT2i (dapagliflozin) in type 2 diabetes mellitus (T2DM) patients with poor control of glucose level by metformin and SGLT2i combination therapy.
The primary objective of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to 24 weeks after the combination therapy of cofrogliptin, metformin and SGLT2i (dapagliflozin) in type 2 diabetes mellitus (T2DM) patients with poor control of glucose level by metformin and SGLT2i combination therapy, as well as the comparison of efficacy of cofrogliptin and linagliptin. Patients will be assigned to receive the treatment of SGLT2i+metformin+cofrogliptn or SGLT2i+metformin+linagliptin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
The combination of SGLT2i+Metformin+Cofrogliptin
The combination of SGLT2i+Metformin+Linagliptin
Wuhan University People's Hospital
Wuhan, Hubei, China
RECRUITINGWuhan University People's Hospital
Wuhan, Hubei, China
RECRUITINGThe change in glycated hemoglobin (HbA1c) levels
To evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to week 24 after triple combination therapy with cofrogliptin added to metformin and sodium-glucose cotransporter 2 inhibitor(SGLT2i) in type 2 diabetes mellitus (T2DM) patients who have inadequately controlled blood glucose despite adequate metformin and SGLT2i therapy.
Time frame: From enrollment to the end of treatment at 24 weeks
HbA1c target rate
Proportion of subjects achieving HbA1c \< 7.0% and \< 6.5% at 24 weeks.
Time frame: From enrollment to the end of treatment at 24 weeks
2h-PPG and FPG
Changes in 2-hour postprandial plasma glucose (2h-PPG) and fasting plasma glucose (FPG) from baseline at 12 and 24 weeks.
Time frame: From enrollment to the end of treatment at 24 weeks
Change in HbA1c levels
Change in HbA1c levels from baseline at 24 weeks.
Time frame: From enrollment to the end of treatment at 24 weeks
Weight related items
Changes in body weight, fasting C-peptide, HOMA-IR, and HOMA-β from baseline at 24 weeks.
Time frame: From enrollment to the end of treatment at 24 weeks
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