Status:
NOT_YET_RECRUITING
Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Type 2 Diabetes
Lead Sponsor:
Yanbing Li
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- Sign the informed consent form.
- Aged ≥18 years.
- Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria).
- 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.
- 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
- Allergic to the study drug.
- Diagnosed with type 1 diabetes.
- Unable to comply with study-specific procedures.
- Current or planned pregnant, or currently breastfeeding.
- With any other situation judged by the investigator, that is unsuitable for participation in this trial.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT07198932
Start Date
October 1 2025
End Date
December 31 2027
Last Update
September 30 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
2
Affiliated Hospital of Hebei University
Baoding, China
3
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, China
4
the First Medical Center of Chinese PLA General Hospital
Beijing, China