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Completed

NCT Number: NCT06329674

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

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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Key information

Conditions

Type2 Diabetes

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes in HbA1c

    Time frame: 24th week

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

Sponsors and collaborators

Lead sponsor

AJU Pharm Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 26, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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