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

A Multicenter, Randomized, Open-label, Controlled Study on Evaluating the Efficacy and Safety of Switching From Daily DPP-4 Inhibitors to HSK7653 Tablets in Patients With Type 2 Diabetes Mellitus in China

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: HSK7653 10 mg; Drug: Daily DPP-4 inhibitor

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Chu Hsien-I Memorial Hospital, Tianjin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HSK7653; HSK7653 10mg Q2W	Drug: HSK7653 10 mg; HSK7653 10 mg Q2W
Active Comparator: Daily DPP-4 inhibitor	Drug: Daily DPP-4 inhibitor; Daily DPP-4 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range	The change in time in range (TIR) of continuous glucose monitoring (CGM) relative to the baseline after 24 weeks of treatment.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change from baseline in HbA1c after 24 weeks	24 weeks
Fasting glucose	Change from baseline in fasting glucose after 24 weeks	24 weeks
Mean glucose	Change from baseline in mean glucose after 24 weeks	24 weeks
Treatment-emergent adverse events.	The incidence of treatment-emergent adverse events.	24 weeks

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): October 5, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: HSK7653; DPP-4i
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Protease Inhibitors; Enzyme Inhibitors; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: HSK7653-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No