NCT07198932

Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Type 2 Diabetes

Effectiveness and Safety of Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Chinese Adults With Type 2 Diabetes Mellitus: a Multicenter, Prospective Real-world Study (COLOR-REAL)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 594 (estimated)
• Sponsor: Yanbing Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, prospective, non-interventional real-world study to evaluate the clinical outcomes of biweekly cofrogliptin versus daily linagliptin as an add-on therapy in Chinese adult T2D patients.

Detailed description

About 43 hospitals from different parts of China will take part in this study. Patients aged ≥18 years who have been previously treated with a stable dose of insulin and no more than three classes of oral antidiabetic drugs (OADs) for at least 12 weeks without adequate glycemic control will be enrolled and assigned to either cofrogliptin once every 2 weeks cohort or linagliptin once-daily cohort based on the prescription. Initiation of cofrogliptin or linagliptin treatment was at the treating physician's discretion. Enrolled participants will undergo routine follow-up for up to 24 weeks. During the follow-up period, data will be collected from face-to-face participant-investigator visits at the beginning of the study (0 weeks, visit 1), early stage (4 weeks, visit 2), mid-stage (12 weeks, visit 3) and at the end of the study (24 weeks, visit 4). Data sources include patient medical records, diaries, self-monitoring of blood glucose (SMBG), and questionnaires. No additional diagnostics, monitoring procedures, or interventions outside of usual clinical practice will be applied to the participants. The project will probably last for about 24 months.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Cofrogliptin add to insulin	Patients will be treated with commercially available cofrogliptin according to routine clinical practice at the discretion of the treating physician.
DRUG	Linagliptin add to insulin	Patients will be treated with commercially available linagliptin according to routine clinical practice at the discretion of the treating physician.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

7 sites across 1 country: China