Metformin Hydrochloride Sustained-release Tablets (Ⅲ) in Patients With Type 2 Diabetes Mellitus Complicated With Coronary Heart Disease
NCT ID: NCT06932874
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
356 participants
INTERVENTIONAL
2025-03-04
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glucophage (Metformin Hydrochloride Tablets)
Metformin hydrochloride tablets combined with other oral hypoglycemic drugs for 24 weeks treatment.
Glucophage (Metformin Hydrochloride Tablets)
Metformin hydrochloride tablets combined with other oral hypoglycemic drugs for 24 weeks treatment.
New type of metformin sustained-release tablets (Ⅲ)
The experimental group received treatment with New Metformin Sustained-release Tablets (Ⅲ) combined with other oral hypoglycemic drugs for 24 weeks.
New sustained-release metformin tablets (Ⅲ)
The experimental group received treatment with New Metformin Sustained-release Tablets (Ⅲ) combined with other oral hypoglycemic drugs for 24 weeks.
Interventions
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Glucophage (Metformin Hydrochloride Tablets)
Metformin hydrochloride tablets combined with other oral hypoglycemic drugs for 24 weeks treatment.
New sustained-release metformin tablets (Ⅲ)
The experimental group received treatment with New Metformin Sustained-release Tablets (Ⅲ) combined with other oral hypoglycemic drugs for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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.
1. Newly diagnosed T2DM patients who only receive dietary control and exercise therapy
2. T2DM patients who have been diagnosed before, with HbA1c still not reaching the standard after oral hypoglycemic drug treatment for at least 12 weeks, and the oral hypoglycemic drugs include two types: dipeptidyl peptidase-4 inhibitors (DPP-4i) and sodium-glucose cotransporter 2 inhibitors (SGLT2i), and have taken these drugs for at least 4 weeks.
* 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
* Within 4 weeks prior to enrollment, had acute coronary syndrome, severe heart disease other than coronary artery disease, or chronic heart failure (NYHA IV grade).
* Patients who had failed PCI, planned staged revascularization, or had other types of stent implantation in the past.
* Patients with acute or chronic pancreatitis, severe neurological diseases, renal dialysis, advanced liver disease, other tumors, organ transplant post-operation, patients with a history of hormone therapy.
* Special types of diabetes, and endocrine diseases such as hyperthyroidism, hypothyroidism, primary aldosteronism, pheochromocytoma, Cushing's syndrome, congenital adrenal cortical hypofunction, pituitary tumor and hypopituitarism, multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma family or personal history, personal history of non-familial medullary thyroid carcinoma.
* Pregnant, in the process of pregnancy or lactation during the postpartum period.
* Within the past 12 weeks, had acute or chronic infectious diseases, fever, anemia, dehydration and electrolyte imbalance, elevated blood lactate level (reaching 2-4 mmol/L).
* Had lactate acidosis in the past (blood lactate ≥ 5 mmol/L, pH value ≤ 7.35 (arterial blood)).
* Liver and kidney dysfunction, with alanine aminotransferase and aspartate aminotransferase ≥ 3 times the upper limit, glomerular filtration rate ≤ 45 ml/min/min.
* Had esophageal reflux, gastric bleeding, peptic ulcer or other severe gastrointestinal diseases within the past 12 weeks.
30 Years
75 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Kefei Dou, MD
Professor
Locations
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Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-0408
Identifier Type: -
Identifier Source: org_study_id
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