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This study evaluated the efficacy and safety of initial combined treatment of Henggliptin, Retagliptin and Metformin by including new type 2 diabetes patients. This study is a multicenter, randomized, open label, positive control study. It is planned to include 160 new type 2 diabetes patients who meet the inclusion criteria of the study. The study is divided into three stages: screening period (V0, -14d-0), treatment period (V1-V8, D1-24w) and safe follow-up period (V9, 28w), with a total of 10 planned visits. This study was divided into an experimental group and a control group. The experimental group received a one-time addition of 10 mg qd of Henggliptin, 100 mg qd of Regagliptin, and 500mg of Metformin. The control group was first treated with metformin. If the blood sugar level did not meet the standard (fasting blood glucose (FPG)>7mmol/L, postprandial blood glucose (PPG)>10mmol/L), Henggeliflozin 10 mg qd was sequentially added. If the blood sugar level did not meet the standard after 4 weeks, Regagliptin 100 mg qd was added. During the follow-up period, evaluate blood glucose control, pancreatic islet function, and safety in both groups of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy | Experimental | Henagliflozin Proline 10 mg qd+Regagliptin 100 mg qd+Metformin 500mg bid. The dose of metformin from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient's tolerance situation. The minimum dose is 1000mg/day. |
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| Sequential treatment group | Active Comparator | Metformin, the dose from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient's tolerance situation. The minimum dose is 1000mg/day. After the fourth week of treatment, blood glucose levels were measured. For those whose blood glucose levels did not meet the standard (fasting blood glucose (FPG)>7mmol/L, postprandial blood glucose (PPG)>10mmol/L), 10 mg qd of Henagliflozin Proline was sequentially added. If the blood glucose levels did not meet the standard after 4 weeks of treatment (FPG>7mmol/L, PPG>10mmol/L), 100 mg qd of Ruigeliflozin was added |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination therapy | Drug | Henagliflozin Proline 10 mg qd+Regagliptin 100 mg qd+Metformin 500mg bid. The dose of metformin from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient's tolerance situation. The minimum dose is 1000mg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with HbA1c<7% at 12w | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with HbA1c<7% at week 24 | From enrollment to the end of treatment at 24 weeks | |
| The proportion of subjects with HbA1c<6.5% at 12 week | From enrollment to the end of treatment at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junqing Zhang | Contact | 8613611167278 | nan.gu@pkufh.cn |
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| Sequential treatment group | Drug | Metformin, the dose from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient's tolerance situation. The minimum dose is 1000mg/day. After the fourth week of treatment, blood glucose levels were measured. For those whose blood glucose levels did not meet the standard (fasting blood glucose (FPG)>7mmol/L, postprandial blood glucose (PPG)>10mmol/L), 10 mg qd of Henagliflozin Prolinewas sequentially added. If the blood glucose levels did not meet the standard after 4 weeks of treatment (FPG>7mmol/L, PPG>10mmol/L), 100 mg qd of Ruigeliflozin was added |
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| The proportion of subjects with HbA1c<6.5% at 24 week | From enrollment to the end of treatment at 24 weeks |
| Changes in HbA1c compared to baseline at 12 weeks | From enrollment to the end of treatment at 12 weeks |
| Changes in HbA1c compared to baseline at 24 weeks | From enrollment to the end of treatment at 24 weeks |
| Changes in fingertip blood glucose (seven point blood glucose spectrum) compared to baseline at 4w, 8w, 12w, and 24w | From enrollment to the end of treatment at 4/8/12/24 weeks |
| Changes in 2hPPG compared to baseline at 4w, 8w, 12w, and 24w | From enrollment to the end of treatment at 4/8/12/24 weeks |
| Changes in FBG compared to baseline at 4w, 8w, 12w, and 24w | From enrollment to the end of treatment at 4/8/12/24 weeks |
| Changes in systolic pressure compared to baseline at 4w, 8w, 12w, and 24w | From enrollment to the end of treatment at 4/8/12/24 weeks |
| Changes in diastolic pressure compared to baseline at 4w, 8w, 12w, and 24w | From enrollment to the end of treatment at 4/8/12/24 weeks |
| Changes in body weight compared to baseline at 4w, 8w, 12w, and 24w | From enrollment to the end of treatment at 4/8/12/24 weeks |
| Changes in waist circumference compared to baseline at 4w, 8w, 12w, and 24w | From enrollment to the end of treatment at 4/8/12/24 weeks |
| Changes in eGFR compared to baseline at 4w, 8w, 12w, and 24w | From enrollment to the end of treatment at 4/8/12/24 weeks |
| Changes in C-peptide levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods | From enrollment to the end of treatment at 12 and 24 weeks |
| Changes in insulin levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods | From enrollment to the end of treatment at 12 and 24 weeks |
| 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 |
|---|---|
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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