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

Sponsor
China National Center for Cardiovascular Diseases
Study ID
NCT06932874
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 4, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
356 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Glycated hemoglobin (HbA1c) [ Time Frame: Baseline, 12 weeks, 24 weeks ]

Central Contacts

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