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

NCT06329674 — Phase 3, Completed, 235 participants, AJU Pharm Co., Ltd.

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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

Registry	NCT06329674
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	235 (Actual)
Sponsor	AJU Pharm Co., Ltd. (Industry)
Conditions	Type2 Diabetes
Interventions	AJU-A51, A51R2, A51R3, AJU-A51 Placebo, A51R2 Placebo (Drug)
Dates	start 2021-04-27, primary completion 2022-12-01, completion 2023-06-13, first posted 2024-03-26, last updated 2024-03-26
Locations	1 site in South Korea

-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

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+Arms and interventions

Arm	Type	Interventions	Description
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

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 19 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Asan Medical Center	Seoul	South Korea

+Publications

Results publication: 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