T2DM
Conditions
Interventions
Cofrogliptin treatment group:None
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female aged >= 18 years (inclusive); 2. According to the WHO diagnostic criteria, the patient is diagnosed with type 2 diabetes mellitus, and is either treatment-naïve or has been on a stable glucose-lowering regimen for at least 8 weeks (i.e., within the 8 weeks prior to screening, only oral antidiabetic drugs [OADs] are used, and the regimen does not include oral GLP-1 receptor agonists or DPP-4 inhibitors); 3. HbA1c at randomization: 7.0% <= HbA1c <= 9.0%; 4. Fasting plasma glucose (FPG) at randomization: FPG <= 11 mmol/L; 5. Body mass index (BMI) at randomization: 18 <= BMI <= 35 kg/m^2; 6. Capable of understanding and voluntarily signing the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.The investigator has determined that initiation of conventional insulin therapy is required during the following 24-week treatment period. 2.Non-Type 2 Diabetes: Type 1 diabetes, gestational diabetes, or other specific types of diabetes; 3.Patients who have experienced serious complications or comorbidities within the past 6 months, such as malignant tumors, unstable angina, myocardial infarction, severe arrhythmias, active severe infections, stroke, diabetic foot ulcers/foot infections, ketoacidosis, etc; 4.Patients with a history of other endocrine diseases severely affecting glucose metabolism, such as multiple endocrine neoplasia, acromegaly, Cushing's syndrome, etc.; or those currently receiving glucocorticoid therapy. 5.Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients; 6.Pregnancy, lactation, or unwillingness to use effective contraception (females/males); 7.Any other condition deemed unsuitable by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetes Treatment Satisfaction (DTSQ);Fasting C-peptide;Fasting Plasma Glucose; | — |
Countries
China
Contacts
Public ContactMengYin Cai
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed