A Multiple-dose, Randomized, Double-blind, Placebo and Positive Controlled Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094 in Subjects With Type 2 Diabetes.

Registration

Registration

NCT06118008

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

DOUBLE

Status

COMPLETED

Enrollment

54

Start

2023-05-31

Primary completion

2024-01-04

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Conditions

Type 2 Diabetes

Interventions

DRUG:HS-20094 5mg; DRUG:HS-20094 10mg; DRUG:HS-20094 15mg; DRUG:HS-20094 20mg

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug [From Baseline to Day 57.]
• The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function [From Baseline to Day 57]
• The changes ECG examination assessed by PR, R-R, QRS and QTcF [From Baseline to Day 57]
• The changes in Blood pressure [From Baseline to Day 57]
• Pulse rate [From Baseline to Day 57]
• Respiratory rate [From Baseline to Day 57]
• Temperature [From Baseline to Day 57]