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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06329674
• Other study ID #: 20DM30203
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

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