Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia

NCT02186080 | Completed DMC

• 1 other identifier: H-1401-089-550
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes mellitus; metabolic endotoxemia; gemigliptin; DPP-4 inhibitor

Outcome Measures

Primary Outcomes (1)

• Difference between baseline and peak serum LPS

  The increment of serum LPS after ingestion of high fat diet

  serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet

Secondary Outcomes (8)

• Fasting serum LPS level

  After 10 hrs of fasting

• Incremental AUC of serum LPS during oral fat tolerance test

  serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet

• Difference between baseline and peak serum triglyceride level

  serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet

• Incremental AUC of serum triglyceride level during oral fat tolerance test

  serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet

• Difference between baseline and peak serum apolipoprotein-B48

  serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet

Study Arms (2)

Gemigliptin

EXPERIMENTAL

Gemigliptin 50mg qd added to subjects current diabetes treatment

Drug: Gemigliptin

Placebo

PLACEBO COMPARATOR

Placebo (identical in appearance to gemigliptin)

Drug: Placebo

Interventions

Gemigliptin DRUG

Also known as: Zemiglo

Gemigliptin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• LG Life Sciences: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

LC15-0444

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Young Min Cho, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 10, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2014-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)