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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06329674
Other study ID # 20DM30203
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 27, 2021
Est. completion date June 13, 2023

Study information

Verified date March 2024
Source AJU Pharm Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 235
Est. completion date June 13, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
AJU-A51
Subjects take the investigational products once a day for 24 weeks.
A51R2
Subjects take the investigational products once a day for 24 weeks.
A51R3
Subjects take the investigational products once a day for 24 weeks.
AJU-A51 Placebo
Subjects take the investigational products once a day for 24 weeks.
A51R2 Placebo
Subjects take the investigational products once a day for 24 weeks.

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
AJU Pharm Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in HbA1c Changes in HbA1c at the 24th week after the administration of investigational products from the baseline 24th week
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