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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYanbing Li

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Allergic to the study drug.

Diagnosed with type 1 diabetes.

Unable to comply with study-specific procedures.

Current or planned pregnant, or currently breastfeeding.

Trial design

Treatments tested in this trial

  • Cofrogliptin add to insulin
  • Linagliptin add to insulin

Treatment groups

594 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yanbing Li

Lead sponsor

Sun Yat-sen University

Sponsor institution