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

NCT06703268 | Completed Phase 2

• 1 other identifier: HSK7653-203
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

HSK7653; DPP-4i

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• HbA1c

  24 weeks

• Fasting glucose

  24 weeks

• Mean glucose

  24 weeks

• Treatment-emergent adverse events.

  24 weeks

Study Arms (2)

HSK7653

EXPERIMENTAL

HSK7653 10mg Q2W

Drug: HSK7653 10 mg

Daily DPP-4 inhibitor

ACTIVE COMPARATOR

Daily DPP-4 inhibitor

Drug: Daily DPP-4 inhibitor

Interventions

HSK7653 10 mg DRUG

HSK7653 10 mg Q2W

HSK7653

Daily DPP-4 inhibitor DRUG

Daily DPP-4 inhibitor

Daily DPP-4 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Chu Hsien-I Memorial Hospital, Tianjin Medical University

Tianjin, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: January 15, 2024
• Primary Completion: October 5, 2024
• Study Completion: November 20, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)