T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
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.
Interventions
DRUGMetformin
The dosage of metformin hydrochloride was consistent with baseline.
DRUGTriple Therapy of Other Oral Antidiabetic Drugs
The dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions.
DRUGganagliflozin
Ganagliflozin tablet : 50mg/d.
DRUGliraglutide
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.
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Those who have a history of chronic or acute pancreatitis before screening, or have clinical manifestations of pancreatitis at the time of screening, or fasting triglycerides \> 5.7 mmol/L during the screening period * Liver function impairment at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 UNL, or total blood bilirubin (TBIL) \> 2 UNL; * Renal impairment at screening: calculated according to the CKD-EPI formula, eGFR≤45 mL/min/1.73m² or serum creatinine≥1.5 UNL; * Patients with a past or family history of medullary thyroid cancer (MTC) and patients with multiple endocrine neoplasia syndrome type 2 (MEN2) * Female subjects who are currently pregnant, breastfeeding, or have a pregnancy plan during the study period * Those who have a history of hypersensitivity reaction to metformin, gapagliflozin, liraglutide injection and other drugs used in research and their excipients or have contraindications to the study drugs; * Those who have participated in other drug clinical trials within 3 months before screening; 21. Subjects who are unable to comply with the protocol under the judgment of the investigator, and those who have other serious physical or psychological diseases that may affect the effectiveness and safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of HbA1c compared to the baseline | from baseline to week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets | week 24 | 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 | week 24 | 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 | 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 | from baseline to week 24 | — |
| Changes in systolic and diastolic blood pressure compared to the baseline | from baseline to week 24 | — |
| The changes of BMI compared to the baseline | from baseline to 24 week | — |
| The changes of waist-hip ratio, waist-to-height ratio compared to the baseline | from baseline to 24 week | — |
| The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline | from baseline to week 24 | — |
| The changes of body mass compared to the baseline | from baseline to 24 week | — |
Other
| Measure | Time frame |
|---|---|
| The changes in total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, alanine aminotransferase, and aspartate aminotransferase compared to the baseline | from baseline to week 120 |
| The proportion of participants who received rescue treatment | from baseline to week 24 |
Countries
China
Contacts
Primary ContactXiaofen Qian
Backup ContactWanting Zhang
Outcome results
None listed