NCT03473262

Brief Summary

This study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared to insulin glargine-based antidiabetic agents (OADs) combination thearpy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

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, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
Last Updated

October 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

March 15, 2018

Last Update Submit

October 18, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesSodium glucose cotransporter 2 inhibitorEmpagliflozinInsulin glargine

Outcome Measures

Primary Outcomes (2)

  • Changes in HbA1c From Baseline to Week 24

    Baseline, Week 24

  • Changes in Fasting Plasma Glucose From Baseline to Week 24

    Baseline, Week 24

Secondary Outcomes (13)

  • Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24

    Baseline, Week 24

  • Changes in HbA1c From Baseline to Week 12

    Baseline, Week 12

  • Changes in Fasting Plasma Glucose From Baseline to Week 12

    Baseline, Week 24

  • Changes in Weight Between Baseline and Week 24

    Baseline, Week 24

  • Changes in Body Mass Index Between Baseline and Week 24

    Baseline, Week 24

  • +8 more secondary outcomes

Study Arms (2)

EMPA

Empagliflozin 25 mg/day

INS

Insulin Glargine dose-titrated

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:

  • Are inadequately controlled with triple OADs (metformin, sulfonylurea, dipeptidyl peptidase inhibitor) as evidenced by HbA1c \>7.5% and \<12.0%

You may not qualify if:

  • Type 1 diabetes
  • Gestional 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 the study
  • Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ChungbukNUH

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 22, 2018

Study Start

January 1, 2017

Primary Completion

July 18, 2018

Study Completion

July 18, 2018

Last Updated

October 19, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share