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Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients

NCT06329674 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2024-03-26

No results posted yet for this study

Summary

A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2

Conditions

  • Type2 Diabetes

Interventions

DRUG

AJU-A51

Subjects take the investigational products once a day for 24 weeks.

DRUG

A51R2

Subjects take the investigational products once a day for 24 weeks.

DRUG

A51R3

Subjects take the investigational products once a day for 24 weeks.

DRUG

AJU-A51 Placebo

Subjects take the investigational products once a day for 24 weeks.

DRUG

A51R2 Placebo

Subjects take the investigational products once a day for 24 weeks.

Sponsors & Collaborators

  • AJU Pharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-27
Primary Completion
2022-12-01
Completion
2023-06-13

Countries

  • South Korea

Study Locations

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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 NCT06329674 on ClinicalTrials.gov