RecruitingPhase 4NCT06932874

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


Sponsor

China National Center for Cardiovascular Diseases

Enrollment

356 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying an extended-release form of metformin — a common diabetes medication — to see how well it works and how safe it is in patients with type 2 diabetes. Extended-release means the drug is released slowly over time, which may reduce side effects compared to regular metformin. **You may be eligible if...** - You have been diagnosed with type 2 diabetes - Your blood sugar is not well-controlled with diet alone or current medications - You are an adult (typically 18 or older) - You have adequate kidney function **You may NOT be eligible if...** - You have significant kidney disease (metformin can be dangerous with poor kidney function) - You have type 1 diabetes - You have severe liver disease - You have a history of lactic acidosis (a rare but serious condition) - You are pregnant or breastfeeding - You drink alcohol heavily Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGlucophage (Metformin Hydrochloride Tablets)

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

DRUGNew 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.


Locations(1)

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

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06932874


Related Trials