Status:
COMPLETED
Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evo...
Eligibility Criteria
Inclusion
- Patients with type II diabetes mellitus aged 19 years or older
- Patients who had taken metformin(≥1000mg/day) and DPP(dipeptidyl peptidase)-4 inhibitor combination therapy(or complex is allowed) at the same dose for at least 8 weeks prior to the screening visit
- Patients with fasting plasma glucose≤250mg/dL at the screening visit
- Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit
- Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study
Exclusion
- Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
- Patients with a medical history of New York Heart Association(NYHA) class III\~IV heart failure or with congestive heart failure, acute and unstable heart failure
- Patients with severe infectious disease or severe traumatic systemic disorders
- Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
- Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2022
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04356742
Start Date
May 26 2020
End Date
February 23 2022
Last Update
March 22 2022
Active Locations (1)
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1
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, South Korea