NCT03173391

Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Hua Medicine Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	HMS5552	BID Oral administration
DRUG	Placebo	BID Oral administration

Timeline

• Start date: 2017-07-18
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2017-06-01
• Last updated: 2021-08-26

Locations

1 site across 1 country: China