Multiple Ascending Doses of SY-009 in Type 2 Diabetes Mellitus
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type 2 Diabetes Mellitus
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 d...
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.
Tracking Information
- NCT #
- NCT04345107
- Collaborators
- Not Provided
- Investigators
- Not Provided