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Metformin Hydrochloride Sustained-release Tablets (Ⅲ) in Patients With Type 2 Diabetes Mellitus Complicated With Coronary Heart Disease

StatusRecruiting
PhasePhase 4
Started2025-03-04
View on ClinicalTrials.gov ↗

Amendment history

2025-04-26
Study Status, Outcome Measures v2
Secondary endpointsdetails revised at 1 of 3 entries
2025-04-17
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria-32 characters
Inclusion Criteria: ① Age: 30 - 75 years old; BMI: 18.5 - 35 kg/m² T2DM meets the [...] disease drugs on hypoglycemic effects. Exclusion Criteria: a. Within 4 weeks prior to enrollment, used glucagon-like peptide-1 receptor agonists (GLP-1RA) or metformin. b. Within 4 weeks prior to enrollment, had acute coronary syndr [...] y artery disease, or chronic heart failure (NYHA IV grade). c. Patients who had failed PCI, planned staged revascularization, or had other types of stent implantation in the past. d. Patients with acute or chronic pancreatitis, severe neurolog [...] post-operation, patients with a history of [...]
Secondary endpointsdetails revised at 2 of 3 entries
2025-04-10
Original filing
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.
Trial Details
NCT Number NCT06932874
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Atherosclerotic Heart Disease, Type 2 Diabetes
Enrollment 356 participants
Start Date 2025-03-04
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-30