Clinical trial NCT06703268: A Study on Switching From Daily DPP-4 Inhibitor to HSK7653 in Type 2 Diabetes Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: HSK7653
DPP-4i
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time in range
timeFrame: 24 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 24 weeks
measure: Fasting glucose
timeFrame: 24 weeks
measure: Mean glucose
timeFrame: 24 weeks
measure: Treatment-emergent adverse events.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Chu Hsien-I Memorial Hospital, Tianjin Medical University
Study officials:
References: