About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet the diagnostic criteria for type 2 diabetes (refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)); -Age: 18-75 years old (including the threshold), male or female;
Body mass index (BMI) ≥20kg/m² ;
Patients who took 1000mg or more of metformin in combination with or without another oral hypoglycemic agent (except SGLT-2i and oral GLP-1RA) for at least 8 weeks before screening and had poor blood glucose control (centralized detection of HBA1C >=7.5% and<=11.0%);
Volunteer to participate in this study and sign informed consent.
Disqualifiers
Patients with type 1 diabetes or other special types of diabetes;
Patients with acute complications of ketoacidosis/hyperglycemic hyperosmolar state/lactic acidosis within 6 months before screening
Those who have used GLP-1RA and SGLT-2i drugs within 12 weeks before screening, or have used GLP-1RA and SGLT-2i drugs in the past and discontinued due to poor efficacy
Those who received insulin treatment within the previous week
Trial design
Parallel
Treatments tested in this trial
Metformin
DrugThe dosage of metformin hydrochloride was consistent with baseline.
Triple Therapy of Other Oral Antidiabetic Drugs
DrugThe dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions.
ganagliflozin
DrugGanagliflozin tablet : 50mg/d.
liraglutide
DrugLiraglutide 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.
Treatment groups
Trial outcomes
Primary outcomes
The change of HbA1c compared to the baseline
Secondary outcomes
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)
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.
The changes of waist circumference and hip circumference compared to the baseline
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
Other outcomes
The changes in total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, alanine aminotransferase, and aspartate aminotransferase compared to the baseline
The proportion of participants who received rescue treatment
Sponsors and contacts
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