Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin 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 Evogliptin When Added to Ongoing Metformin and Dapagliflozin 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 Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Drug: Evogliptin 5mg; Drug: Dapagliflozin 10mg; Drug: Metformin ≥ 1000mg; Drug: Evogliptin Placebo

• Study Type: Interventional
• Enrollment (Actual): 283
• Phase: Phase 3

Contacts and Locations

Study Locations

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

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:

• Patients with Type II diabetes mellitus aged 19 years or older

• Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy

  1. Subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit
  2. Subjects who are receiving metformin ≥ 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit
• Subjects with 7.0%≤HbA1c≤10.5% at screening visit
• Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
• Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit

Exclusion Criteria:

• Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis
• patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
• Patients with severe infectious disease or severe traumatic systemic disorders
• End stage renal disease or dialysis patients
• Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Evogliptin 5mg group; Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d	Drug: Evogliptin 5mg; Participants receive Evogliptin 5mg orally once a day; Other Names: Suganon; Drug: Dapagliflozin 10mg; Participants receive Dapagliflozin orally once a day; Other Names: Forxiga; Drug: Metformin ≥ 1000mg; Metformin are administered at the same dose and formulation.
PLACEBO_COMPARATOR: Evogliptin Placebo group; Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d	Drug: Dapagliflozin 10mg; Participants receive Dapagliflozin orally once a day; Other Names: Forxiga; Drug: Metformin ≥ 1000mg; Metformin are administered at the same dose and formulation.; Drug: Evogliptin Placebo; Participants receive placebo to match Evogliptin 5mg orally once a day; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c (%) After 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in FPG(mg/dL) After 24 weeks	24 weeks
Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks	24 weeks
Change from baseline in 7-point SMBG After 24 weeks	24 weeks

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2020
• Primary Completion (ACTUAL): June 28, 2021
• Study Completion (ACTUAL): December 8, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

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_DMTD_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