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

NCT06329674 | Completed Phase 3

• 1 other identifier: 20DM30203
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c

  Changes in HbA1c at the 24th week after the administration of investigational products from the baseline

  24th week

Study Arms (2)

AJU-A51+A51R2 placebo+A51R3

EXPERIMENTAL

Drug: AJU-A51; Drug: A51R3; Drug: A51R2 Placebo

AJU-A51 placebo+A51R2+A51R3

EXPERIMENTAL

Drug: A51R2; Drug: A51R3; Drug: AJU-A51 Placebo

Interventions

AJU-A51 DRUG

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

AJU-A51+A51R2 placebo+A51R3

A51R2 DRUG

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

AJU-A51 placebo+A51R2+A51R3

A51R3 DRUG

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

AJU-A51 placebo+A51R2+A51R3; AJU-A51+A51R2 placebo+A51R3

AJU-A51 Placebo DRUG

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

AJU-A51 placebo+A51R2+A51R3

A51R2 Placebo DRUG

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

AJU-A51+A51R2 placebo+A51R3

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who voluntarily signed the informed consent to participate in this study.
• Adults aged 19-75 years.
• Those diagnosed with type 2 diabetes mellitus.
• % ≤ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Hong JH, Kim MJ, Min KW, Won JC, Kim TN, Lee BW, Kang JG, Kim JH, Park JH, Ku BJ, Lee CB, Kim SY, Shon HS, Lee WJ, Park JY. Efficacy and safety of a fixed-dose combination of dapagliflozin and linagliptin (AJU-A51) in patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, parallel-group, placebo-controlled phase III study. Diabetes Obes Metab. 2025 Jan;27(1):81-91. doi: 10.1111/dom.15985. Epub 2024 Oct 7.

  PMID: 39375869 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: April 27, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 13, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)