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

NCT06932874 | Recruiting Phase 4

• 1 other identifier: 2025-0408
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerotic Heart Disease; Type 2 Diabetes

Keywords

Type 2 diabetes; coronary atherosclerotic heart disease; metformin hydrochloride sustained-release tablets (Ⅲ)

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (HbA1c)

  Glycated hemoglobin (HbA1c) at baseline, 12 weeks and 24 weeks through venous blood samples

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (3)

• Fasting blood glucose

  baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

• Gastrointestinal adverse reactions

  baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

• Medication Adherence

  12 weeks, 24 weeks

Study Arms (2)

Glucophage (Metformin Hydrochloride Tablets)

ACTIVE COMPARATOR

Metformin hydrochloride tablets combined with other oral hypoglycemic drugs for 24 weeks treatment.

Drug: Glucophage (Metformin Hydrochloride Tablets)

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.

Drug: New sustained-release metformin tablets (Ⅲ)

Interventions

Glucophage (Metformin Hydrochloride Tablets) DRUG

Metformin hydrochloride tablets combined with other oral hypoglycemic drugs for 24 weeks treatment.

Glucophage (Metformin Hydrochloride Tablets)

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.

New type of metformin sustained-release tablets (Ⅲ)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Newly diagnosed T2DM patients who only receive dietary control and exercise therapy
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Xiaojue Li MD, PhD

CONTACT

+86-10-18610154960; lixiaojue@fuwai.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)