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

NCT ID: NCT04356742

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-26
• Study Completion Date: 2022-02-23

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dapagliflozin 10mg + Evogliptin 5mg + Metformin

Group Type: EXPERIMENTAL

Dapagliflozin 10mg

Intervention Type: DRUG

Dapagliflozin 10mg, orally, once daily, up to 24weeks

Evogliptin 5mg

Intervention Type: DRUG

Evogliptin 5mg, orally, once daily for background therapy

Metformin≥1000mg

Intervention Type: DRUG

Metformin≥1000mg, orally, daily for background therapy

Dapagliflozin Placebo + Evogliptin 5mg + Metformin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dapagliflozin Placebo, orally, once daily, up to 24weeks

Evogliptin 5mg

Intervention Type: DRUG

Evogliptin 5mg, orally, once daily for background therapy

Metformin≥1000mg

Intervention Type: DRUG

Metformin≥1000mg, orally, daily for background therapy

Interventions

Dapagliflozin 10mg

Dapagliflozin 10mg, orally, once daily, up to 24weeks

Intervention Type: DRUG

Placebo

Dapagliflozin Placebo, orally, once daily, up to 24weeks

Intervention Type: DRUG

Evogliptin 5mg

Evogliptin 5mg, orally, once daily for background therapy

Intervention Type: DRUG

Metformin≥1000mg

Metformin≥1000mg, orally, daily for background therapy

Intervention Type: DRUG

Other Intervention Names

Forxiga; Suganon

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Catholic University of Korea Bucheon St. Mary's Hospital

Bucheon-si, , South Korea

Countries

South Korea

Other Identifiers

DA1229_DMTD2_III

Identifier Type: -

Identifier Source: org_study_id