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RECRUITING
NCT06863532
NA

Efficacy and Safety Comparison of Cofrogliptin Add-on Versus Metformin Dose-escalation in Type 2 Diabetes Patients Inadequately Controlled With SGLT-2 Inhibitors Plus Low-Dose Metformin:A Multicenter, Open-Label Trial

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

The aim of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin. Participants will be asked to use either cofrogliptin combined with SGLT2i and metformin or SGLT2i combined with increased dose of metformin.

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-03-30

Completion Date

2026-09-01

Last Updated

2025-03-07

Healthy Volunteers

No

Conditions

Interventions

DRUG

Cofrogliptin+SGLT2i+Metformin

The cofrogliptin add-on group will continue their existing SGLT2i plus metformin regimen and dosing, with the add-on of cofrogliptin over 24 weeks of triple combined therapy.

DRUG

Metformin dose escalation

The metformin dose escalation group will have their metformin dose gradually increased to the target dose.

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China