NCT04326166

Brief Summary

Multi-center, open, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,971

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 25, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

February 17, 2021

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

March 26, 2020

Last Update Submit

February 15, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    To assess change from baseline in HbA1c

    at 12 weeks

Secondary Outcomes (3)

  • Change in HbA1c

    at 24 weeks

  • The percentage of patients with HbA1c <7.0% and <6.5%

    at 12 and 24 weeks

  • Change in FPG

    at 12 and 24 weeks

Study Arms (3)

Group A

Patients who receive Double therapy or Insulin

Drug: Evogliptin

Group B

Patients who receive DPP-4 inhibitor

Drug: Evogliptin

Group C

Drug-naïve patients

Drug: Metformin and Evogliptin

Interventions

EvogliptinDRUG

Evogliptin

Also known as: Suganon, Sugamet XR
Group A
Metformin and EvogliptinDRUG

Metformin and Evogliptin

Also known as: Suganon, Sugamet XR
Group C

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Type 2 DM patients

You may qualify if:

  • The subject is aged ≥19 years
  • The subject has type 2 diabetes mellitus

You may not qualify if:

  • \. The subject has a contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanggye paik pospital

Seoul, Nowon-gu, 01757, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

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

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Jongchul Won, M.D., Ph.D.

CONTACT

+82-2-950-8860dronjc@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 30, 2020

Study Start

March 25, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

February 17, 2021

Record last verified: 2020-03

Locations

KR(1)