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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Xiaojue Li MD, PhD
lixiaojue@fuwai.com
+86-10-18610154960
Time Frame
Start Date: 2025-03-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 356
Treatments
Active_comparator: Glucophage (Metformin Hydrochloride Tablets)
Metformin hydrochloride tablets combined with other oral hypoglycemic drugs for 24 weeks treatment.
Experimental: New type of metformin sustained-release tablets (Ⅲ)
The experimental group received treatment with New Metformin Sustained-release Tablets (Ⅲ) combined with other oral hypoglycemic drugs for 24 weeks.
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov

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