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

20DM30203

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

2021-04-27

2022-12-01

2023-06-13

Completed

Early phase I

235

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

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2024-03-26