Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.

Sponsor
Huazhong University of Science and Technology
Study ID
NCT07019012
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SGLT2i+Metformin+Cofrogliptin — DRUG
    The combination of SGLT2i+Metformin+Cofrogliptin
  • SGLT2i+Metformin+Linagliptin — DRUG
    The combination of SGLT2i+Metformin+Linagliptin

Study Details

This study is designed to evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to 24 weeks after the combination therapy of cofrogliptin, metformin and SGLT2i (dapagliflozin) in type 2 diabetes mellitus (T2DM) patients with poor control of glucose level by metformin and SGLT2i combination therapy.

Key Dates

Start date
Jul 30, 2025
Status verified
Jun 2025
Primary completion
Oct 30, 2026
Completion
Dec 30, 2026

Study Design

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

Arms

  • Experimental: Cofrogliptin Add-on Group
    Triple combination therapy with cofrogliptin added to metformin and SGLT2i in type 2 diabetes mellitus (T2DM) patients who have inadequately controlled blood glucose despite adequate metformin and SGLT2i therapy for at least 12 weeks.
  • Active Comparator: Linagliptin active-control Group
    Triple combination therapy with linagliptin as active-control drug added to metformin and SGLT2i in type 2 diabetes mellitus (T2DM) patients who have inadequately controlled blood glucose despite adequate metformin and SGLT2i therapy for at least 12 weeks.

Primary Outcome Measure

The change in glycated hemoglobin (HbA1c) levels [ Time Frame: From enrollment to the end of treatment at 24 weeks ]

Central Contacts

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