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

NCT ID: NCT07198932

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 594 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cofrogliptin cohort

Cofrogliptin add to insulin

Intervention Type: DRUG

Patients will be treated with commercially available cofrogliptin according to routine clinical practice at the discretion of the treating physician.

Linagliptin cohort

Linagliptin add to insulin

Intervention Type: DRUG

Patients will be treated with commercially available linagliptin according to routine clinical practice at the discretion of the treating physician.

Interventions

Cofrogliptin add to insulin

Patients will be treated with commercially available cofrogliptin according to routine clinical practice at the discretion of the treating physician.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form.

2. Aged ≥18 years.

3. Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria).

4. Recently tested HbA1c 7%-9% and FPG ≤11 mmol/L, with stable treatment using insulin ± OADs for at least 12 weeks prior to enrollment. Insulin regimens are limited to: basal insulin once daily or once weekly, premixed insulin once or twice daily, or IDegAsp once or twice daily. OAD classes are limited to metformin, SGLT2 inhibitors, and α-glucosidase inhibitors and with no more than three agents in total.

5. Willing to start or have already initiated cofrogliptin or linagliptin treatment (at the physician's discretion in accordance with clinical practice). The treatment decision is independent of study enrollment, must be made before signing the informed consent, and cofrogliptin or linagliptin initiation must occur either within 2 weeks before or within 2 weeks after signing the informed consent.

Exclusion Criteria

1. Allergic to the study drug.

2. Diagnosed with type 1 diabetes.

3. Unable to comply with study-specific procedures.

4. Current or planned pregnant, or currently breastfeeding.

5. With any other situation judged by the investigator, that is unsuitable for participation in this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanbing Li

OTHER

Sponsor Role: lead

Responsible Party

Yanbing Li

First Affiliated Hospital, Sun Yat-Sen University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Affiliated Hospital of Hebei University

Baoding, , China

Beijing Luhe Hospital Affiliated to Capital Medical University

Beijing, , China

the First Medical Center of Chinese PLA General Hospital

Beijing, , China

Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University

Shanghai, , China

Shanghai Changzheng Hospital

Shanghai, , China

Xi'an International Medical Center Hospital

Xi'an, , China

Countries

China

Other Identifiers

IIT-2025-340

Identifier Type: -

Identifier Source: org_study_id