NCT04170998

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

1.5 years

First QC Date

November 13, 2019

Last Update Submit

December 8, 2021

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c (%) After 24 weeks

    24 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Evogliptin 5mg group

EXPERIMENTAL

Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d

Drug: Evogliptin 5mgDrug: Dapagliflozin 10mgDrug: Metformin ≥ 1000mg

Evogliptin Placebo group

PLACEBO COMPARATOR

Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d

Drug: Evogliptin PlaceboDrug: Dapagliflozin 10mgDrug: Metformin ≥ 1000mg

Interventions

Evogliptin 5mgDRUG

Participants receive Evogliptin 5mg orally once a day

Also known as: Suganon
Evogliptin 5mg group
Evogliptin PlaceboDRUG

Participants receive placebo to match Evogliptin 5mg orally once a day

Also known as: Placebo
Evogliptin Placebo group
Dapagliflozin 10mgDRUG

Participants receive Dapagliflozin orally once a day

Also known as: Forxiga
Evogliptin 5mg groupEvogliptin Placebo group
Metformin ≥ 1000mgDRUG

Metformin are administered at the same dose and formulation.

Evogliptin 5mg groupEvogliptin Placebo group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

Related Publications (1)

  • Moon JS, Park IR, Kim HJ, Chung CH, Won KC, Han KA, Park CY, Won JC, Kim DJ, Koh GP, Kim ES, Yu JM, Hong EG, Lee CB, Yoon KH. Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension. Diabetes Metab J. 2023 Nov;47(6):808-817. doi: 10.4093/dmj.2022.0387. Epub 2023 Sep 26.

    PMID: 37750183DERIVED

MeSH Terms

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-onedapagliflozinMetformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 20, 2019

Study Start

January 2, 2020

Primary Completion

June 28, 2021

Study Completion

December 8, 2021

Last Updated

December 10, 2021

Record last verified: 2021-12

Locations

KR(1)