Comparing new metformin sustained-release tablets to regular metformin in patients with type 2 diabetes and coronary heart disease
Study on the Efficacy and Safety of Metformin Hydrochloride Dicarboxylate Sustained-release Tablets (Ⅲ) in Patients With Type 2 Diabetes Mellitus Complicated With Coronary Heart Disease: An Open, Randomized Controlled Trial
This study is testing if a new type of metformin tablet helps people with type 2 diabetes and heart disease manage their blood sugar better than the regular metformin.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 356 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06932874 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of new sustained-release metformin hydrochloride tablets compared to standard metformin tablets in patients with type 2 diabetes mellitus who also have coronary heart disease. A total of 356 patients will be randomly assigned to receive either the new formulation or the standard treatment for 24 weeks. The primary outcomes include changes in glycated hemoglobin and fasting blood glucose levels, as well as gastrointestinal side effects and patient compliance. Follow-up assessments will occur at various intervals to monitor these outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 75 with type 2 diabetes and coronary heart disease, who meet specific blood glucose criteria.
Not a fit: Patients with type 2 diabetes who do not have coronary heart disease or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood sugar levels and reduced side effects for patients with type 2 diabetes and coronary heart disease.
How similar studies have performed: Previous studies have shown that metformin is effective in managing type 2 diabetes, but the specific sustained-release formulation is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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, used glucagon-like peptide-1 receptor agonists (GLP-1RA) or metformin. * 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.
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiaojue Li MD, PhD
- Email: lixiaojue@fuwai.com
- Phone: +86-10-18610154960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.