Type 2 Diabetes
Conditions
Keywords
HSK7653, DPP-4i
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.
Interventions
DRUGHSK7653 10 mg
HSK7653 10 mg Q2W
Daily DPP-4 inhibitor
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 24 weeks | The change in time in range (TIR) of continuous glucose monitoring (CGM) relative to the baseline after 24 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 24 weeks | Change from baseline in HbA1c after 24 weeks |
| Fasting glucose | 24 weeks | Change from baseline in fasting glucose after 24 weeks |
| Mean glucose | 24 weeks | Change from baseline in mean glucose after 24 weeks |
| Treatment-emergent adverse events. | 24 weeks | The incidence of treatment-emergent adverse events. |
Countries
China
Outcome results
None listed