Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM

Haisco Pharmaceutical Group

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: HSK7653 10 mg; Drug: Placebo; Drug: HSK7653 50 mg; Drug: HSK7653 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06059326

HSK7653-201

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

48 participants in 4 patient groups, including a placebo group

HSK7653 10 mg

Experimental group

Treatment:

Drug: HSK7653 10 mg

HSK7653 25 mg

Experimental group

Treatment:

Drug: HSK7653 25 mg

HSK7653 50 mg

Experimental group

Treatment:

Drug: HSK7653 50 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo