Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia
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ClinicalTrials.gov Identifier: NCT02186080 |
Recruitment Status
:
Completed
First Posted
: July 10, 2014
Last Update Posted
: April 21, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: Gemigliptin Drug: Placebo | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Evaluation of the Effect of Gemigliptin on Metabolic Endotoxemia and Lipemia Induced by High Fat Diet in Patients With Type 2 Diabetes |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Gemigliptin
Gemigliptin 50mg qd added to subjects current diabetes treatment
|
Drug: Gemigliptin
Other Name: Zemiglo
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Placebo Comparator: Placebo
Placebo (identical in appearance to gemigliptin)
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Drug: Placebo |
- Difference between baseline and peak serum LPS [ Time Frame: serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet ]The increment of serum LPS after ingestion of high fat diet
- Fasting serum LPS level [ Time Frame: After 10 hrs of fasting ]Compare fasting LPS level between treatment group
- Incremental AUC of serum LPS during oral fat tolerance test [ Time Frame: serum LPS before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet ]Calculated incremental AUC of serum LPS
- Difference between baseline and peak serum triglyceride level [ Time Frame: serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet ]The increment of serum TG after ingestion of high fat diet
- Incremental AUC of serum triglyceride level during oral fat tolerance test [ Time Frame: serum TG before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet ]Calculated incremental AUC of serum TG
- Difference between baseline and peak serum apolipoprotein-B48 [ Time Frame: serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet ]The increment of serum apolipoprotein-B48 after ingestion of high fat diet
- Incremental AUC of serum apolipoprotein-B48 during oral fat tolerance test [ Time Frame: serum apolipoprotein-B48 before high fat diet and 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr after high fat diet ]Calculated incremental AUC of serum apolipoprotein-B48
- Serum level of inflammatory markers (CRP, TNF-alpha, IL-6) [ Time Frame: After 10 hr of fasting ]Compare serum level of inflammatory markers between treatment groups
- mRNA expression level of inflammatory markers in the adipose tissue [ Time Frame: After high fat diet ingestion ]Compare mRNA expression level of inflammatory markers

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186080
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 110-744 |
Principal Investigator: | Young Min Cho, MD, PhD | Seoul National University Hospital |
Responsible Party: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT02186080 History of Changes |
Other Study ID Numbers: |
H-1401-089-550 |
First Posted: | July 10, 2014 Key Record Dates |
Last Update Posted: | April 21, 2016 |
Last Verified: | July 2014 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Seoul National University Hospital:
diabetes mellitus metabolic endotoxemia gemigliptin DPP-4 inhibitor |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Endotoxemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Bacteremia |
Sepsis Infection Toxemia Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |