NCT03877406

Brief Summary

The purpose of this study is to evaluate changes of body composition induced by Sodium-glucose cotransporter-2 (SGLT2) inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).

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
200

participants targeted

Target at P75+ for phase_4 diabetes-mellitus

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_4 diabetes-mellitus

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

August 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

5.4 years

First QC Date

October 23, 2018

Last Update Submit

August 10, 2023

Conditions

Diabetes MellitusFat; Intolerance, Pancreas

Keywords

Sodium-glucose transporter 2 inhibitor

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    glycemic control

    6 months

Secondary Outcomes (6)

  • Biochemical parameters

    6 months

  • Body weight

    6 months

  • Body fat

    6 months

  • Systolic and diastolic blood pressures

    6 months

  • Lipid profile

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

up-titration of standard medication including monotherapy or combination of Metformin, Sulfonylurea, DPP4 inhibitor

Drug: Hypoglycemics Oral

Study group

EXPERIMENTAL

addition of empagliflozin 10mg qd on standard oral antihyperglycemic agents

Drug: Empagliflozin 10 MG

Interventions

Empagliflozin 10 MGDRUG

addition of empagliflozin 10 MG

Also known as: SGLT2 inhibitor
Study group
Hypoglycemics OralDRUG

dose escalation of hypoglycemics oral

Also known as: Oral antidiabetic medication escalation
Control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes Age: 20-79 years BMI ≥ 20 kg/m2 eGFR ≥ 45

You may not qualify if:

  • Patients with type 1 diabetes Secondary diabetes due to Cushing diseases, acromegaly Insulin user BMI \< 20 kg/m2 eGFR \< 45 Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusPlatelet Glycoprotein IV Deficiency

Interventions

empagliflozinSodium-Glucose Transporter 2 InhibitorsHypoglycemic Agents

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Soo N Lim, MD, PHD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujin N Shin, MD

CONTACT

82-31-787-703554256@snubh.org

Soo N Lim

CONTACT

82317877035limsoo@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Division Chief of Endocrinology and Metabolism

Study Record Dates

First Submitted

October 23, 2018

First Posted

March 15, 2019

Study Start

August 1, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

KR(1)