Type 2 Diabetes Mellitus
Conditions
Brief summary
To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.
Interventions
DRUGHSK7653 10 mg
Tablet, HSK7653 10 mg Q2W, 12 weeks
DRUGHSK7653 25 mg
Tablet, HSK7653 25 mg Q2W, 12 weeks
DRUGHSK7653 50 mg
Tablet, HSK7653 50 mg Q2W, 12 weeks
DRUGPlacebo
Tablet, 0 mg Q2W, 12 weeks
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 and Age ≤70 years * T2DM patients, * Control the blood glucose level only with diet and exercise in last 3 months; * BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index) * HbA1c ≥7.0% and HbA1c \<10.0% * FPG \<13.9 mmol/L
Exclusion criteria
* Non-type 2 diabetes mellitus: Type 1 diabetes mellitus, gestational diabetes history; * History of acute complications of diabetes (diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome or lactic acidosis); * History of chronic complications of severe diabetes (retinal proliferative disease, severe diabetic neuropathy or intermittent claudication confirmed by fundus examination during screening); * Patients who used systemic glucocorticoids within 3 months prior to screening had severe infections or major surgeries and transplants within 3 months; * Three or more episodes of hypoglycemia occurred in the six months prior to screening; * History of hyperthyroidism within 6 months before screening; * Severe cardiovascular disease. ; * Medical conditions that may significantly affect drug absorption, distribution, metabolism, and excretion within 2 weeks prior to screening; * Liver function tests abnormal; * Moderate or severe renal impairment; * Medical history or clinical evidence of pancreatic injury or pancreatitis, or abnormalities in lipase and amylase judged by investigators to be clinically significant; * Patients with a history of hypertension who regularly take antihypertensive therapy for over 4 weeks still have poor control, SBP \> 160 mmHg and (or) DBP \> 100 mmHg; * Patients with uncontrolled hyperlipidemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks | Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of HSK7653 | Day 1 to Day 43 | AUC of HSK7653 after first dose and multi-dose administration |
| Half-life (t1/2) of HSK7653 | Day 1 to Day 43 | T1/2 of HSK7653 after single-dose and multi-dose administration |
| Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate | Day 1 to Day 84 | Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate after single-dose and multi-dose administration of HSK7653 |
| Peak plasma concentration (Cmax) of HSK7653 | Day 1 to Day 43 | Cmax of HSK7653 after first dose and multi-dose administration |
| Change from baseline of fasting plasma glucose | Day 1 to Day 84 | Change from baseline in fasting plasma glucose after multi-dose administration of HSK7653 |
| Change from baseline of HbA1c | Day 1 to Day 84 | Change from baseline in HbA1c after multi-dose administration of HSK7653 |
| Change from baseline in GLP-1 | Day 1 to Day 84 | Change from baseline in GLP-1 after single-dose and multi-dose administration of HSK7653 |
Countries
China
Outcome results
None listed