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

Haisco Pharmaceutical Group

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: HSK7653 10 mg

Drug: Daily DPP-4 inhibitor

Study type

Interventional

Funder types

Industry

Identifiers

HSK7653-203

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.