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

NCT07122102 | Not Yet Recruiting

• 1 other identifier: HSK7653-503
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes

Conditions

Type 2 Diabetes

Keywords

cofrogliptin; acarbose; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c

  The difference in HbA1c from the baseline

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (10)

• FPG (Fasting plasma glucose)

  From enrollment to the end of treatment at 12 weeks

• 2h-PPG (2-hour postprandial glucose)

  From enrollment to the end of treatment at 12 weeks

• Fasting C-peptide

  From enrollment to the end of treatment at 12 weeks

• Insulin sensitivity

  From enrollment to the end of treatment at 12 weeks

• Islet function

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Cofrogliptin （HSK7653）

EXPERIMENTAL

Cofrogliptin tablets,10mg administered once every two weeks

Drug: Cofrogliptin

Acarbose

ACTIVE COMPARATOR

Acarbose tablets, 50mg administered three times daily

Drug: Acarbose

Interventions

Cofrogliptin DRUG

10mg administered once every two weeks

Cofrogliptin （HSK7653）

Acarbose DRUG

50mg administered 3 times daily

Acarbose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of understanding and voluntarily signing the written informed consent form.
• 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.
• 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.

You may not qualify if:

• Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients.
• History of diabetic ketoacidosis, type 1 diabetes, pancreatic/β-cell transplantation, or diabetes secondary to pancreatitis/pancreatectomy.
• Acute coronary syndrome (STEMI/NSTEMI/unstable angina), stroke, or transient ischemic attack (TIA) within 3 months prior to informed consent.
• 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).
• Bariatric surgery or malabsorptive gastrointestinal procedures within past 2 years.
• Anti-obesity medications within 3 months prior to consent or weight instability at screening.
• Malignancy (except basal cell carcinoma) within 5 years and/or active cancer therapy.
• HIV infection. 14.Severe peripheral vascular disease. 15.Hematological disorders causing hemolysis/erythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia).
• Current systemic corticosteroid use, thyroid hormone dose changes within 6 weeks, or uncontrolled endocrine disorders (excluding T2DM).
• Substance abuse within 3 months or chronic conditions potentially compromising compliance.
• Pregnancy, lactation, or unwillingness to use effective contraception (females/males).
• Participation in other clinical trials within 30 days prior to screening. 20.Any other condition deemed unsuitable by the investigator.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

He'nan Provincial People's Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Central Study Contacts

Fangqiong Li

CONTACT

+86 028-67258; lifangq@haisco.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)