Type2 Diabetes Clinical Trial
Official 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
Verified date | March 2024 |
Source | AJU Pharm Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 235 |
Est. completion date | June 13, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
AJU Pharm Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in HbA1c | Changes in HbA1c at the 24th week after the administration of investigational products from the baseline | 24th week |
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