Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia

NCT ID: NCT02186080

Last Updated: 2016-04-21

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

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-07-31

Brief Summary

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This is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes. The investigators will measure systemic endotoxin level and lipid level after ingestion of high fat diet to evaluate the effect of gemigliptin, a DPP-4 inhibitor, on metabolic endotoxemia and lipemia induced by high fat diet.

Detailed Description

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Study subjects will be allocated to either gemigliptin or placebo. After 4 weeks of treatment and 2 weeks of wash out period, all subjects will be switched to the opposite arm.

The subjects will be tested oral fat tolerance test and adipose tissue needle biopsy(only for the subjects who agreed to participate donate adipose tissue) at 3 time points: the start of 1st treatment, end of 1st treatment and end of 2nd treatment.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gemigliptin

Gemigliptin 50mg qd added to subjects current diabetes treatment

Group Type EXPERIMENTAL

Gemigliptin

Intervention Type DRUG

Placebo

Placebo (identical in appearance to gemigliptin)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Gemigliptin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Zemiglo

Eligibility Criteria

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Inclusion Criteria

* Age from 20 to 75
* At least 6 months from the diagnosis of type 2 diabetes
* Current diabetes treatment: life style modification and/or metformin and/or sulfornylurea
* No change of the diabetes treatment (drug number and dossage) in recent 3 months
* HbA1c 6.5% to 10%

Exclusion Criteria

* Recent cardiovascular event in 6 months
* Concurrent use of statin or fibrate or ezetimibe
* Renal failure, chronic liver disease
* Pregnancy or lactation
* Use of other DPP-4 inhibitor or GLP-1 analogue in recent 3 months
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young Min Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1401-089-550

Identifier Type: -

Identifier Source: org_study_id

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