Compares cofrogliptin with acarbose in adults with type 2 diabetes not on medicine
Compares cofrogliptin and acarbose in adults newly treated for type 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study Comparing the Efficacy and Safety of Cofrogliptin Versus Acarbose in Drug-Naïve Patients With Type 2 Diabetes
Key facts
- Where
- Zhengzhou, ChinaSee the site
Where in China
- He'nan Provincial People's HospitalZhengzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haisco Pharmaceutical Group Co., Ltd.
- Trial code
- NCT07122102
- Record updated
- 26 September 2025
- Original description
This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetesRead full original descriptionShow less
A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study Comparing the Efficacy and Safety of Cofrogliptin Versus Acarbose in Drug-Naïve Patients With Type 2 Diabetes
This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes
Inclusion: 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: 1.Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients; 2.History of diabetic ketoacidosis, type 1 diabetes, pancreatic/β-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.