Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

Diabetes Mellitus, Type 2 Clinical Trial

Official title: A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 With Additional 28-week Open-label Treatment to Evaluate the Safety of HMS5552 Alone in T2DM Subjects

Status Completed

Clinical Trial Summary

This study evaluates the efficacy and safety and population PK of HMS5552 as monotherapy in adult type 2 diabetic subjects, there will be 2 groups in the first 24 weeks, one group will receive HMS5552 , while the other group will receive placebo ; after 24 weeks, all subjects will receive HMS5552 for 28 weeks.

Clinical Trial Description

This study is a phase III study in subjects with T2DM. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects. The eligible subjects are randomly assigned to HMS5552 75mg BID group or placebo BID group with ratio 2:1 to receive a 24-week double-blind treatment. Then all subjects receive 28-week open-label treatment of HMS5552 75mg BID . After 52-week treatment, all investigational drugs should be discontinued, followed by 1 week for safety evaluation. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

• NCT number: NCT03173391
• Study type: Interventional
• Source: Hua Medicine Limited
• Status: Completed
• Phase: Phase 3
• Start date: July 18, 2017
• Completion date: November 30, 2020