NCT06932874

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 356 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 356 patients with type 2 diabetes mellitus complicated with coronary heart disease were selected. According to the usage of oral hypoglycemic drugs before enrollment, they were divided into the group without using hypoglycemic drugs, the single-drug group (SGLT2i), and the dual-drug group (SGLT2i + DPP4i). Within the same group of subjects, they were randomly divided into the treatment group with the new metformin sustained-release tablets (Ⅲ) (referred to as the experimental group) and the control group with Glucophage (referred to as the control group) at a ratio of 1:1 for 24 weeks of intervention. 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

• Atherosclerotic Heart Disease
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Glucophage (Metformin Hydrochloride Tablets)	Metformin hydrochloride tablets combined with other oral hypoglycemic drugs for 24 weeks treatment.
DRUG	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.

Timeline

• Start date: 2025-03-04
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-04-17
• Last updated: 2025-04-30

Locations

1 site across 1 country: China