The aim of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin. Participants will be asked to use either cofrogliptin combined with SGLT2i and metformin or SGLT2i combined with increased dose of metformin.
The primary objective of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin. The secondary objectives of this study are to evaluate the changes in the following parameters (for indicators requiring pre-post comparison, the baseline level during the baseline treatment period is used for comparison):of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin: 1. The proportion of subjects with HbA1c \< 7.0% and \< 6.5% after 24 weeks of treatment. 2. Changes in 2-hour postprandial plasma glucose (2h-PPG) and fasting plasma glucose (FPG) from baseline at 12 and 24 weeks of treatment. 3. Change in HbA1c levels from baseline after 12 weeks of treatment. 4. Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function from baseline after 24 weeks of treatment. 5. The proportion of subjects who withdrew due to the need for rescue therapy for hyperglycemia. 6. The safety profile of triple therapy with cofrogliptin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The cofrogliptin add-on group will continue their existing SGLT2i plus metformin regimen and dosing, with the add-on of cofrogliptin over 24 weeks of triple combined therapy.
The metformin dose escalation group will have their metformin dose gradually increased to the target dose.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGthe change in glycated hemoglobin (HbA1c) levels
the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therap
Time frame: throughout the study, about 1 year
The proportion of subjects with HbA1c < 7.0% and < 6.5%
The proportion of subjects with HbA1c \< 7.0% and \< 6.5% after 24 weeks of treatment.
Time frame: throughout the study, about 1 year
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 of treatment.
Time frame: throughout the study, about 1 year
Change in HbA1c levels
Change in HbA1c levels from baseline after 12 weeks of treatment.
Time frame: throughout the study, about 1 year
Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function
Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function from baseline after 24 weeks of treatment.
Time frame: throughout the study, about 1 year
proportion of subjects who withdrew
The proportion of subjects who withdrew due to the need for rescue therapy for hyperglycemia.
Time frame: throughout the study, about 1 year
The safety profile
The safety profile of triple therapy with cofrogliptin.
Time frame: throughout the study, about 1 year
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