A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the 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 Co., Ltd.1 site in 1 country198 target enrollmentMay 26, 2020

ConditionsType 2 Diabetes

InterventionsDapagliflozin 10mg Evogliptin 5mg Metformin≥1000mg Placebo

DrugsDapagliflozin 10mg Placebo Evogliptin 5mg Metformin≥1000mg

Overview

Phase: Phase 3
Intervention: Dapagliflozin 10mg
Conditions: Type 2 Diabetes
Sponsor: Dong-A ST Co., Ltd.
Enrollment: 198
Locations: 1
Primary Endpoint: Change from the baseline in HbA1c (%) after 24 weeks
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 26, 2020

End Date

February 23, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dong-A ST Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Arms & Interventions

Dapagliflozin 10mg + Evogliptin 5mg + Metformin

Intervention: Dapagliflozin 10mg

Dapagliflozin 10mg + Evogliptin 5mg + Metformin

Intervention: Evogliptin 5mg

Dapagliflozin 10mg + Evogliptin 5mg + Metformin

Intervention: Metformin≥1000mg

Dapagliflozin Placebo + Evogliptin 5mg + Metformin

Intervention: Placebo

Dapagliflozin Placebo + Evogliptin 5mg + Metformin

Intervention: Evogliptin 5mg

Dapagliflozin Placebo + Evogliptin 5mg + Metformin

Intervention: Metformin≥1000mg

Outcomes

Primary Outcomes

Change from the baseline in HbA1c (%) after 24 weeks

Time Frame: Baseline, 24 weeks

Secondary Outcomes

Change from the baseline in weight after 24 weeks(Baseline, 24 weeks)
Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks(Baseline, 24 weeks)
Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks(Baseline, 24 weeks)