The main objective of this study is to compare the efficacy and safety of the triple combination therapy of Met/SGLT-2i/GLP-1RA or other oral antidiabetic drugs in patients with type 2 diabetes exhibiting poor glycemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
The dosage of metformin hydrochloride was consistent with baseline.
The dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions.
Ganagliflozin tablet : 50mg/d.
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe change of HbA1c compared to the baseline
Time frame: from baseline to week 24
The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets
HbA1c ≤ 7.0% Blood pressure \< 130/80 mmHg For subjects without ASCVD, LDL-C \< 2.6 mmol/L; for subjects with ASCVD, LDL-C \< 1.8 mmol/L (\< 70 mg/dL)
Time frame: week 24
The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning
HbA1c target ≤ 7.0% The definition of hypoglycemia is: Blood glucose \< 70 mg/dL ( \< 3.9 mmol/L), regardless of whether there are symptoms of hypoglycemia.
Time frame: week 24
The changes of waist circumference and hip circumference compared to the baseline
Time frame: from baseline to week 24
The changes of fasting blood glucose, 2-hour post-meal blood glucose, fasting glucagon, fasting insulin, insulin resistance index (HOMA-IR) compared to the baseline
Time frame: from baseline to week 24
Changes in systolic and diastolic blood pressure compared to the baseline
Time frame: from baseline to week 24
The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline
Time frame: from baseline to week 24
The changes of body mass compared to the baseline
Time frame: from baseline to 24 week
The changes of BMI compared to the baseline
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Liraglutide injection: 0.6 mg/d for the first week, 1.2 mg/d for the second week, and 1.8 mg/d after the third week.
Time frame: from baseline to 24 week
The changes of waist-hip ratio, waist-to-height ratio compared to the baseline
Time frame: from baseline to 24 week