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

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Dapagliflozin 10mg; Drug: Evogliptin 5mg; Drug: Metformin≥1000mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04356742

DA1229_DMTD2_III

Details and patient eligibility

About

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 evogliptin, while the other half will receive placebo, metformin and evogliptin.

Enrollment: 198 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with type II diabetes mellitus aged 19 years or older
2. 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
3. Patients with fasting plasma glucose≤250mg/dL at the screening visit
4. Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
5. Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion criteria

1. Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
2. 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
3. Patients with severe infectious disease or severe traumatic systemic disorders
4. Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
5. Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
6. Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

198 participants in 2 patient groups, including a placebo group

Dapagliflozin 10mg + Evogliptin 5mg + Metformin

Experimental group

Treatment:

Drug: Evogliptin 5mg

Drug: Dapagliflozin 10mg

Drug: Metformin≥1000mg

Dapagliflozin Placebo + Evogliptin 5mg + Metformin

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Evogliptin 5mg

Drug: Metformin≥1000mg