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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Dapagliflozin 10mg; Drug: Evogliptin 5mg; Drug: Metformin≥1000mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dapagliflozin 10mg + Evogliptin 5mg + Metformin	Drug: Dapagliflozin 10mg; Dapagliflozin 10mg, orally, once daily, up to 24weeks; Other Names: Forxiga; Drug: Evogliptin 5mg; Evogliptin 5mg, orally, once daily for background therapy; Other Names: Suganon; Drug: Metformin≥1000mg; Metformin≥1000mg, orally, daily for background therapy
PLACEBO_COMPARATOR: Dapagliflozin Placebo + Evogliptin 5mg + Metformin	Drug: Evogliptin 5mg; Evogliptin 5mg, orally, once daily for background therapy; Other Names: Suganon; Drug: Metformin≥1000mg; Metformin≥1000mg, orally, daily for background therapy; Drug: Placebo; Dapagliflozin Placebo, orally, once daily, up to 24weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 26, 2020
• Primary Completion (ACTUAL): February 23, 2022
• Study Completion (ACTUAL): February 23, 2022

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (ACTUAL): April 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 20, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin; Metformin
• Other Study ID Numbers: DA1229_DMTD2_III

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No