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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Cofrogliptin; Drug: Acarbose

• Registration Number: NCT07122102
• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

This study will enroll treatment-naïve patients with type 2 diabetes who meet inclusion criteria, and randomize them 1:1 to either the coglitin treatment group or the acarbose treatment group for a 12-week open-label parallel-controlled treatment period, with the coglitin group receiving 10mg coglitin tablets once every two weeks and the acarbose group receiving 50mg acarbose tablets three times daily; the primary endpoint is the change in glycated hemoglobin (HbA1c) from baseline at week 12, followed by a 1-week safety follow-up visit after treatment completion, with study conclusion upon completion of this safety visit.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-09-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cofrogliptin （HSK7653）	Cofrogliptin	Cofrogliptin tablets,10mg administered once every two weeks
Acarbose	Acarbose	Acarbose tablets, 50mg administered three times daily

Primary Outcome Measures

Name	Time	Method
HbA1c	From enrollment to the end of treatment at 12 weeks	The difference in HbA1c from the baseline

Secondary Outcome Measures

Name	Time	Method
FPG (Fasting plasma glucose)	From enrollment to the end of treatment at 12 weeks	The difference in FPG from the baseline
2h-PPG (2-hour postprandial glucose)	From enrollment to the end of treatment at 12 weeks	The difference in 2h-PPG from the baseline
Fasting C-peptide	From enrollment to the end of treatment at 12 weeks	The difference in fasting C-peptide from the baseline
Insulin sensitivity	From enrollment to the end of treatment at 12 weeks	The difference in insulin sensitivity from the baseline
Islet function	From enrollment to the end of treatment at 12 weeks	The difference in Islet function from the baseline
Body weight	From enrollment to the end of treatment at 12 weeks	The difference in body weight from the baseline
Intestinal microbial composition and functional characteristics	From enrollment to the end of treatment at 12 weeks	The difference in intestinal microbial composition and functional characteristics from the baseline
Incidence of hypoglycemia	From enrollment to the end of safety visitation at 13 weeks	The percentage of subjects who experienced any investigator-defined hypoglycemic adverse event
Gastrointestinal adverse events	From enrollment to the end of safety visitation at 13 weeks	The percentage of subjects who experienced any investigator-defined gastrointestinal adverse events adverse event
Other adverse events	From enrollment to the end of safety visitation at 13 weeks	The percentage of subjects who experienced any investigator-defined adverse event

Trial Locations

Locations (1)

He'nan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China