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Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects

NCT03141073 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 767

Last updated 2021-08-26

No results posted yet for this study

Summary

This study evaluates the efficacy and safety and population PK of HMS5552 add-on to Metformin in adult type 2 diabetic subjects. There will be 2 groups in the first 24 weeks, one group will receive HMS5552 plus Metformin, while the other group will receive placebo plus Metformin; after 24 weeks, all subjects will receive HMS5552 plus Metformin for 28 weeks.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

HMS5552

BID oral administration

DRUG

Placebo

BID oral administration

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Hua Medicine Limited

    lead INDUSTRY

Principal Investigators

  • Wenying Yang, MD · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-15
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141073 on ClinicalTrials.gov