Safety and Efficacy Evaluation of Cofrogliptin (HSK7653) and Acarbose Research Among T2DMs

Launched by HAISCO PHARMACEUTICAL GROUP CO., LTD. · Aug 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how safe and effective a new medicine called cofrogliptin (HSK7653) is compared to an existing medicine called acarbose for people with type 2 diabetes. Type 2 diabetes is a condition where the body has trouble controlling blood sugar levels. The study will help doctors understand if cofrogliptin works well and is safe to use.

People who might be able to join this study are adults aged 18 or older who have been diagnosed with type 2 diabetes but have only managed it through diet and exercise, without taking diabetes medicines before. Their blood sugar levels should be moderately high but not too extreme, and they should have a body weight within a certain range. Participants will need to keep their usual diet and exercise routine during the study. The trial is not yet recruiting, and there are several health conditions that would exclude someone from joining, like recent heart problems or other serious illnesses. If you take part, you can expect to be closely monitored to see how well the medicine controls blood sugar and to check for any side effects.

Gender

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Eligibility 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:
• • 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.