type 2 diabetes
Conditions
Interventions
Cofrogliptin treatment group:Cofrogliptin
Acarbose treatment group:Acarbose
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Capable of understanding and voluntarily signing the written informed consent form. 2. Male or female aged >=18 years (inclusive). 3. Fulfills diagnostic criteria for type 2 diabetes mellitus. 4. Previous glycemic control managed exclusively through diet and exercise therapy, with no prior exposure to any glucose-lowering or diabetes-related medications. 5. HbA1c at randomization: 7.0% <= HbA1c <= 9.0%. 6. Fasting plasma glucose (FPG) at randomization: FPG <= 11 mmol/L. 7. Body mass index (BMI) at randomization: 18 <= BMI <= 35 kg/m². 8. Agrees to maintain consistent dietary and exercise habits throughout the trial period.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients. 2. History of diabetic ketoacidosis, type 1 diabetes, pancreatic/ß-cell transplantation, or diabetes secondary to pancreatitis/pancreatectomy. 3. Acute coronary syndrome (STEMI/NSTEMI/unstable angina), stroke, or transient ischemic attack (TIA) within 3 months prior to informed consent. 4. Congestive heart failure (NYHA Class III-IV). 5. Uncontrolled hypertension (systolic BP >=180 mmHg or diastolic BP >=110 mmHg). 6. Hepatic impairment: ALT, AST, or ALP >3×ULN at screening. 7. Severe renal impairment (eGFR <25 mL/min/1.73m²). 8. Chronic gastrointestinal disorders with significant malabsorption. 9. Conditions potentially aggravated by intestinal gas (e.g., Roemheld syndrome, severe hernia, intestinal obstruction/ulceration). 10. Bariatric surgery or malabsorptive gastrointestinal procedures within past 2 years. 11. Anti-obesity medications within 3 months prior to consent or weight instability at screening. 12. Malignancy (except basal cell carcinoma) within 5 years and/or active cancer therapy. 13. HIV infection. 14. Severe peripheral vascular disease. 15. Hematological disorders causing hemolysis/erythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia). 16. Current systemic corticosteroid use, thyroid hormone dose changes within 6 weeks, or uncontrolled endocrine disorders (excluding T2DM). 17. Substance abuse within 3 months or chronic conditions potentially compromising compliance. 18. Pregnancy, lactation, or unwillingness to use effective contraception (females/males). 19. Participation in other clinical trials within 30 days prior to screening. 20. Any other condition deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose;fasting C-peptide;Abundance of gut microbiota; | — |
Countries
China
Contacts
Public ContactHuijuan Yuan
Henan Provincial People's Hospita,medical
Outcome results
None listed