Empagliflozin-based Quadruple Combination vs Insulin Glarine-based Combination Therapy in Patients With Type 2 Diabetes

NCT ID: NCT03473262

Last Updated: 2018-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-07-18

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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EMPA

Empagliflozin 25 mg/day

No interventions assigned to this group

INS

Insulin Glargine dose-titrated

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chungbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eu Jeong Ku

ChungbukNUH

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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eujeongku

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-03-011

Identifier Type: -

Identifier Source: org_study_id

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