Clinical trial NCT06059326: Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM
Official title: A Multicenter, Randomized, Double-blind, Placebo Control, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks
Secondary outcomes:
measure: Peak plasma concentration (Cmax) of HSK7653
timeFrame: Day 1 to Day 43
measure: Area under the plasma concentration versus time curve (AUC) of HSK7653
timeFrame: Day 1 to Day 43
measure: Half-life (t1/2) of HSK7653
timeFrame: Day 1 to Day 43
measure: Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate
timeFrame: Day 1 to Day 84
measure: Change from baseline in GLP-1
timeFrame: Day 1 to Day 84
measure: Change from baseline of fasting plasma glucose
timeFrame: Day 1 to Day 84
measure: Change from baseline of HbA1c
timeFrame: Day 1 to Day 84
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university people's hospital
state: Beijing
Study officials:
References: