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

Aju Pharm

Status and phase

Completed

Phase 3

Conditions

Type2 Diabetes

Treatments

Drug: A51R2 Placebo

Drug: A51R3

Drug: AJU-A51 Placebo

Drug: A51R2

Drug: AJU-A51

Study type

Interventional

Funder types

Industry

Identifiers

NCT06329674

20DM30203

Details and patient eligibility

About

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

Enrollment

235 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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