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

March 25, 2024 updated by: AJU Pharm Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

235

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Those who voluntarily signed the informed consent to participate in this study.
  • Adults aged 19-75 years.
  • Those diagnosed with type 2 diabetes mellitus.
  • 7% ≤ HbA1c ≤ 10.5%
  • FPG ≤ 270 mg/dL
  • BMI ≤ 40 kg/㎡
  • Subjects able to understand the study, comply with study procedures, and attend all scheduled visits.

Exclusion Criteria:

  • Those who suffered from acute or chronic metabolic acidosis, lactic acidosis and diabetic ketoacidosis.
  • Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
  • Those with heart failure (NYHA class II~IV) or who had suffered from heart failure.
  • Those with a history of malignant tumor within 5 years
  • Those who have a clinically significant liver disease
  • Those who have a clinically significant renal disease
  • SBP > 180 mmHg or DBP > 110 mmHg
  • Those who had allergic reaction to main ingredients or components of the investigational products.
  • Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
  • Females who are pregnant or breastfeeding.
  • AST or ALT ≥ LRN*3
  • TG ≥ 500 mg/dL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AJU-A51+A51R2 placebo+A51R3
Drug: AJU-A51
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: A51R2 Placebo
Subjects take the investigational products once a day for 24 weeks.
Experimental: AJU-A51 placebo+A51R2+A51R3
Drug: A51R3
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: AJU-A51 Placebo
Subjects take the investigational products once a day for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in HbA1c
Time Frame: 24th week
Changes in HbA1c at the 24th week after the administration of investigational products from the baseline
24th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AJU Pharm Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

June 13, 2023

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20DM30203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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