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The purpose of this study is1. Compare the differences in the changes of glycated hemoglobin after 24 weeks of treatment between the new metformin sustained-release tablets (Ⅲ) group and the metformin ordinary tablets group.
2. Compare the differences in the changes of fasting blood glucose, gastrointestinal adverse reactions of the drug and compliance after 24 weeks of treatment between the new metformin sustained-release tablets (Ⅲ) group and the metformin ordinary tablets group.
A total of 356 patients with type 2 diabetes mellitus complicated with coronary heart disease were selected. According to the usage of oral hypoglycemic drugs before enrollment, they were divided into the group without using hypoglycemic drugs, the single-drug group (SGLT2i), and the dual-drug group (SGLT2i + DPP4i). Within the same group of subjects, they were randomly divided into the treatment group with the new metformin sustained-release tablets (Ⅲ) (referred to as the experimental group) and the control group with Glucophage (referred to as the control group) at a ratio of 1:1 for 24 weeks of intervention.
Outpatient follow-ups were conducted at baseline, 12 weeks, and 24 weeks, and the differences in glycated hemoglobin, fasting blood glucose changes, gastrointestinal adverse reactions, and compliance were compared between the two groups.
Telephone follow-ups were conducted at 4 weeks, 8 weeks, 16 weeks, and 20 weeks to compare the differences in fingertip blood glucose, gastrointestinal adverse reactions, and compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucophage (Metformin Hydrochloride Tablets) | Active Comparator | Metformin hydrochloride tablets combined with other oral hypoglycemic drugs for 24 weeks treatment. |
|
| New type of metformin sustained-release tablets (Ⅲ) | Experimental | The experimental group received treatment with New Metformin Sustained-release Tablets (Ⅲ) combined with other oral hypoglycemic drugs for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucophage (Metformin Hydrochloride Tablets) | Drug | Metformin hydrochloride tablets combined with other oral hypoglycemic drugs for 24 weeks treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c) at baseline, 12 weeks and 24 weeks through venous blood samples | Baseline, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose | Baseline, 12 weeks, 24 weeks samples were collected by venous blood draw; while 4 weeks, 8 weeks, 16 weeks and 20 weeks samples were collected by fingertip blood draw. | baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks |
| Gastrointestinal adverse reactions |
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Inclusion Criteria:
Age: 30 - 75 years old; BMI: 18.5 - 35 kg/m²
T2DM meets the WHO standards of 1999, with HbA1c ranging from 7% to 9%, and fasting blood glucose ranging from 7 to 10 mmol/L.
Before admission or during this admission, coronary heart disease was diagnosed by coronary angiography, and standard coronary heart disease routine treatment was carried out, including standard antiplatelet therapy, lipid-lowering therapy, and control of ventricular rate. Beta-blockers were uniformly treated with metoprolol sustained-release tablets, and antiplatelet drugs were uniformly treated with aspirin to avoid the influence of coronary heart disease drugs on hypoglycemic effects.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojue Li MD, PhD | Contact | +86-10-18610154960 | lixiaojue@fuwai.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| New sustained-release metformin tablets (Ⅲ) | Drug | The experimental group received treatment with New Metformin Sustained-release Tablets (Ⅲ) combined with other oral hypoglycemic drugs for 24 weeks. |
|
Evaluate using the "Metformin Adverse Reaction Assessment Form",The scale consists of six items related to dyspepsia symptoms. Each item has a minimum score of 0, indicating no symptoms, and a maximum score of 3, representing symptoms that affect daily life. The higher the score, the more obvious the symptoms are and the worse the outcome. |
| baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks |
| Medication Adherence | Medication adherence is evaluated by actual dosage, required dosage and medication treatment rate. Medication treatment rate: assesses the continuous treatment rate of metformin in both groups, the rate of continuous treatment at different dosages, the dropout rate. Continuous treatment rate: refers to the number of people who have been treated with metformin for 12 weeks or 24 weeks / total number of people. Continuous different dosage treatment rate: includes the continuous treatment rate of metformin at 1500mg/day and 2000mg/day doses, referring to the number of people who have been treated with metformin at 1500mg/day or 2000mg for 12 weeks or 24 weeks / total number of people. Discontinuation rate: refers to the number of people who discontinued metformin treatment at 12 weeks or 24 weeks during follow-up / total number of people. | 12 weeks, 24 weeks |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| 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 |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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