NCT06329674

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: AJU Pharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	AJU-A51	Subjects take the investigational products once a day for 24 weeks.
DRUG	A51R2	Subjects take the investigational products once a day for 24 weeks.
DRUG	A51R3	Subjects take the investigational products once a day for 24 weeks.
DRUG	AJU-A51 Placebo	Subjects take the investigational products once a day for 24 weeks.
DRUG	A51R2 Placebo	Subjects take the investigational products once a day for 24 weeks.

Timeline

• Start date: 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 across 1 country: South Korea