Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia

Seoul National University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Gemigliptin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02186080

H-1401-089-550

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Gemigliptin

Experimental group

Description:

Gemigliptin 50mg qd added to subjects current diabetes treatment

Treatment:

Drug: Gemigliptin

Placebo

Placebo Comparator group

Description:

Placebo (identical in appearance to gemigliptin)

Treatment:

Drug: Placebo