NCT03748810

Brief Summary

This open-labeled, prospective, observational, 3-year, clinical study was conducted to compare the effectiveness and safety between empagliflozin (25 mg once daily) and dapagliflozin (10 mg once daily) in patients with inadequately controlled type 2 diabetes despite preexisting triple OAD combination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

6.5 years

First QC Date

November 19, 2018

Last Update Submit

July 19, 2022

Conditions

Type2 Diabetes

Keywords

EmpagliflozinDapagliflozinSodium-glucose cotransporter 2 inhibitorsQuadruple combination antidiabetic drugs

Outcome Measures

Primary Outcomes (2)

  • Changes in HbA1c from baseline to week 156 (3-year)

    Changes in HbA1c from baseline to week 156 (3-year)

    Baseline, week 156 (3-year)

  • Changes in fasting plasma glucose from baseline to week 156 (3-year)

    Changes in fasting plasma glucose from baseline to week 156 (3-year)

    Baseline, week 156 (3-year)

Secondary Outcomes (27)

  • Changes in HbA1c from baseline to week 104 (2-year)

    Baseline, week 104 (2-year)

  • Changes in HbA1c from baseline to week 52 (1-year)

    Baseline, week 52 (1-year)

  • Changes in HbA1c from baseline to week 24

    Baseline, Week 24

  • Changes in fasting plasma glucose from baseline to week 12

    Baseline, Week 12

  • Changes in fasting plasma glucose from baseline to week 24

    Baseline, Week 24

  • +22 more secondary outcomes

Study Arms (1)

Triple OADs failure

Empagliflozin or dapagliflozin as an add-on drug for inadequately controlled T2D patients who are already receiving a regimen of three distinct OADs, including metformin, glimepiride and dipeptidyl peptidase 4 (DPP4) inhibitors.

Drug: EmpagliflozinDrug: Dapagliflozin

Interventions

EmpagliflozinDRUG

Empagliflozin 25 mg once daily add on the background OADs for 3 years

Also known as: Metformin, Glimepiride, DPP4 inhibitor
Triple OADs failure
DapagliflozinDRUG

Dapagliflozin 25 mg once daily add on the background OADs for 3 years

Also known as: Metformin, Glimepiride, DPP4 inhibitor
Triple OADs failure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists

You may qualify if:

  • Inadequately controlled under triple OADs (metformin, glimepiride, dipeptidyl peptidase inhibitor) as evidenced by HbA1c 7.5-12%

You may not qualify if:

  • Type 1 diabetes
  • Gestational diabetes
  • Diabetes due to secondary causes
  • Receiving anticancer treatment
  • Receiving glucocorticoids or immune-suppressants
  • have been treated with sodium-glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheonju, North Chungcheong, 28644, South Korea

Location

Related Publications (2)

  • Ku EJ, Lee DH, Jeon HJ, Oh TK. Long-term effectiveness and safety of quadruple combination therapy with empagliflozin versus dapagliflozin in patients with type 2 diabetes: 3-year prospective observational study. Diabetes Res Clin Pract. 2021 Dec;182:109123. doi: 10.1016/j.diabres.2021.109123. Epub 2021 Nov 3.

    PMID: 34740742DERIVED

  • Ku EJ, Lee DH, Jeon HJ, Oh TK. Empagliflozin versus dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin, glimepiride and dipeptidyl peptide 4 inhibitors: A 52-week prospective observational study. Diabetes Res Clin Pract. 2019 May;151:65-73. doi: 10.1016/j.diabres.2019.04.008. Epub 2019 Apr 4.

    PMID: 30954510DERIVED

MeSH Terms

Interventions

empagliflozinMetforminglimepirideDipeptidyl-Peptidase IV Inhibitorsdapagliflozin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • Jae Hyun Ahn

    Chungbuk National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 21, 2018

Study Start

January 1, 2016

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

KR(1)