Cofrogliptin add to insulinLinagliptin add to insulin
Cofrogliptin add to insulin: Patients will be treated with commercially available cofrogliptin according to routine clinical practice at the discretion of the treating physician.
Linagliptin add to insulin: Patients will be treated with commercially available linagliptin according to routine clinical practice at the discretion of the treating physician.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in HbA1c — from baseline to 24 weeks
Trial sites (7)
Facility
City
Region
Status
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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