A Study on Switching From Daily DPP-4 Inhibitor to HSK7653 in Type 2 Diabetes Patients

NCT ID: NCT06703268

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-11-20

Brief Summary

To assess the effectiveness of HSK7653 tablets following the substitution of daily DPP-4 inhibitor (DPP-4i) over a 24-week treatment period.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HSK7653

HSK7653 10mg Q2W

Group Type: EXPERIMENTAL

HSK7653 10 mg

Intervention Type: DRUG

HSK7653 10 mg Q2W

Daily DPP-4 inhibitor

Daily DPP-4 inhibitor

Group Type: ACTIVE_COMPARATOR

Daily DPP-4 inhibitor

Intervention Type: DRUG

Daily DPP-4 inhibitor

Interventions

HSK7653 10 mg

HSK7653 10 mg Q2W

Intervention Type: DRUG

Daily DPP-4 inhibitor

Daily DPP-4 inhibitor

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥18 and Age ≤75 years
• T2DM patients,
• During the 12 weeks before screening, on the basis of diet control and exercise therapy, patients only regularly received daily DPP-4 inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin and retagliptin , etc.) or combined with metformin (with a metformin dose of ≥ 1500 mg/day, or the maximum tolerated dose < 1500 mg/day but ≥ 1000 mg/day);
• HbA1c ≥6.5% and HbA1c <8.0%
• FPG <10.0 mmol/L
• BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)

Exclusion Criteria

• Non-type 2 diabetes: Type 1 diabetes, gestational diabetes or other special types of diabetes.
• The presence of any of the following medical histories or conditions at the time of screening:
• History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the recent 6 months;
• History of ≥2 episodes of severe hypoglycemia within the last 6 months;
• History of malignant tumors within the recent 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ), or currently being evaluated for potential malignant tumors.
• Presence of severe mental disorders or language barriers, unwilling or unable to fully understand and cooperate.
• History of drug abuse within the past 5 years
• Previous history or clinical evidence of acute or chronic pancreatitis.
• Using other drugs that may affect blood glucose metabolism within 12 weeks prior to screening, including systemic glucocorticoids (except for inhaled or topical ones), growth hormones, etc.
• Any laboratory test index meeting the following criteria:
• Hemoglobin < 110 g/L (for males) or < 100 g/L (for females).
• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times the upper limit of the normal value.
• Total bilirubin (TBIL) > 2 times the upper limit of the normal value.
• Fasting triglyceride (TG) > 5.7 mmol/L.
• Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula < 45 mL/min/1.73m².
• Known to be allergic to the investigational products or related excipients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Hsien-I Memorial Hospital, Tianjin Medical University

Tianjin, , China

Countries

China

Other Identifiers

HSK7653-203

Identifier Type: -

Identifier Source: org_study_id