Type2 Diabetes
Conditions
Brief 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
Interventions
DRUGA51R2
Subjects take the investigational products once a day for 24 weeks.
DRUGA51R3
Subjects take the investigational products once a day for 24 weeks.
DRUGAJU-A51
Subjects take the investigational products once a day for 24 weeks.
DRUGAJU-A51 Placebo
Subjects take the investigational products once a day for 24 weeks.
DRUGA51R2 Placebo
Subjects take the investigational products once a day for 24 weeks.
Sponsors
AJU Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c | 24th week | Changes in HbA1c at the 24th week after the administration of investigational products from the baseline |
Countries
South Korea
Outcome results
None listed