NCT04356742

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes

Timeline
Completed

Started May 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

April 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

April 20, 2020

Last Update Submit

March 20, 2022

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change from the baseline in HbA1c (%) after 24 weeks

    Baseline, 24 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Dapagliflozin 10mg + Evogliptin 5mg + Metformin

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

Dapagliflozin Placebo + Evogliptin 5mg + Metformin

PLACEBO COMPARATOR
Drug: PlaceboDrug: Evogliptin 5mgDrug: Metformin≥1000mg

Interventions

Dapagliflozin 10mgDRUG

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

Also known as: Forxiga
Dapagliflozin 10mg + Evogliptin 5mg + Metformin
PlaceboDRUG

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

Dapagliflozin Placebo + Evogliptin 5mg + Metformin
Evogliptin 5mgDRUG

Evogliptin 5mg, orally, once daily for background therapy

Also known as: Suganon
Dapagliflozin 10mg + Evogliptin 5mg + MetforminDapagliflozin Placebo + Evogliptin 5mg + Metformin
Metformin≥1000mgDRUG

Metformin≥1000mg, orally, daily for background therapy

Dapagliflozin 10mg + Evogliptin 5mg + MetforminDapagliflozin Placebo + Evogliptin 5mg + Metformin

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
  • 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
  • Patients with fasting plasma glucose≤250mg/dL at the screening visit
  • Patients with 18.5kg/m\^2≤BMI≤40kg/m\^2 at the screening visit
  • Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

You may not qualify if:

  • Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
  • 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
  • Patients with severe infectious disease or severe traumatic systemic disorders
  • Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
  • Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
  • Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bucheon-si, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 22, 2020

Study Start

May 26, 2020

Primary Completion

February 23, 2022

Study Completion

February 23, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

KR(1)