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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04356742

Enrollment

198

Registered

2020-04-22

Start date

2020-05-26

Completion date

2022-02-23

Last updated

2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

DRUGDapagliflozin 10mg

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

DRUGPlacebo

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

DRUGEvogliptin 5mg

Evogliptin 5mg, orally, once daily for background therapy

DRUGMetformin≥1000mg

Metformin≥1000mg, orally, daily for background therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from the baseline in HbA1c (%) after 24 weeks	Baseline, 24 weeks

Secondary

Measure	Time frame
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
Change from the baseline in weight after 24 weeks	Baseline, 24 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026