Multiple Ascending Doses of SY-009 in Type 2 Diabetes Mellitus

Status Completed

Clinical Trial Summary

This is a phase Ib placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SY-009 after Multiple Ascending Doses in patients with Type 2 Diabetes Mellitus (T2DM).

Clinical Trial Description

This is a multicenter, randomized, double-blind, placebo-controlled, dose-increasing, multiple oral administration clinical trial. The planned dose escalation levels were 1, 2, 3 and 4 mg daily (6 dose groups). After the completion of the test and safety evaluation of the initial dose of 1mg daily dose in two groups (0.5mg bid and 1mg QD), the main researchers of the team leader and the sponsor jointly determine whether to enter the 2mg daily dose study. After the completion of the test and safety evaluation of two groups (1mg bid and 2mg QD) of 2mg daily dose, the main researchers of the group leader and the sponsor jointly determine whether to enter the 4mg daily dose study. If the test and safety assessment of 4mg daily dose group (2mg bid) are completed and the dose termination standard is not met, the test will be terminated; if the safety assessment during or after the test reaches the dose termination standard, the study of 3mg daily dose group (1.5mg bid) will be carried out, and then the test will be terminated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04345107
Study type	Interventional
Source	Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	May 1, 2020
Completion date	September 21, 2021

View Details

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