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

NCT04356742 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2022-03-22

No results posted yet for this study

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

Interventions

DRUG

Dapagliflozin 10mg

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

DRUG

Placebo

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

DRUG

Evogliptin 5mg

Evogliptin 5mg, orally, once daily for background therapy

DRUG

Metformin≥1000mg

Metformin≥1000mg, orally, daily for background therapy

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2022-02-23
Completion
2022-02-23

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356742 on ClinicalTrials.gov