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

N/ANot Yet RecruitingNCT07198932

Yanbing Li594 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

594

Conditions

Type 2 Diabetes

Interventions

Cofrogliptin add to insulinDRUG

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

Linagliptin add to insulinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

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

Outcomes

Primary Outcomes

Change in HbA1c

Time frame: from baseline to 24 weeks

Secondary Outcomes

Change in HbA1c

Time frame: from baseline to 12 weeks

Reaching of HbA1c target (defined as HbA1c less than 7%)

Percentage point

Time frame: at 24 weeks

Change in FPG

mmol/L

Time frame: from baseline to 24 weeks

Change in PPG

mmol/L

Time frame: from baseline to 24 weeks

Change in fasting C peptide

ng/mL

Time frame: from baseline to 24 weeks

Change in body weight

Time frame: from baseline to 24 weeks

Change in insulin dose

units/day

Time frame: from baseline to 24 weeks

Overall safety, consisting of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest

Time frame: from baseline to 24 weeks

Data from ClinicalTrials.gov

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