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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Met+SGLT-2i+GLP-1RA | Experimental | Metformin+Ganagliflozin+Liraglutide |
|
| Triple Therapy of Other Oral Antidiabetic Drugs | Active Comparator | Building upon the previously stable treatment regimen, the addition of 1-2 oral hypoglycemic agents (excluding SGLT-2 inhibitors and oral GLP-1 receptor agonists) constitutes a triple oral hypoglycemic regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | The dosage of metformin hydrochloride was consistent with baseline. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change of HbA1c compared to the baseline | from baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | week 24 |
| The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofen Qian | Contact | +86-0571-89908582 | qianxiaofen@eastchinapharm.com | |
| Wanting Zhang | Contact | +86-0571-89905517 | zhangwanting@eastchinapharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| Triple Therapy of Other Oral Antidiabetic Drugs |
| Drug |
The dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions. |
|
| ganagliflozin | Drug | Ganagliflozin tablet : 50mg/d. |
|
| liraglutide | Drug | 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. |
|
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. |
| week 24 |
| 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 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 |
| 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 |
| from baseline to week 24 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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