Effects of Vildagliptine and Glimepiride on Glucose Variability
NCT ID: NCT01812122
Last Updated: 2015-11-20
Study Results
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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COMPLETED
PHASE4
16 participants
INTERVENTIONAL
2013-03-31
2015-10-31
Brief Summary
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Detailed Description
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Before drug administration, we conduct basal lab study including CGMS. After 3 month of random administration of vildagliptin or glimepiride, we check CGMS, glucose levels, CV biomarkers, and estimate hypoglycemic index. We replace with the other drug for 3 months, and then conduct the same measurements. No wash-out period is necessary since result variables are measured after the 3 months of administration for a different drug.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Glimepiride
Starting with Glimepiride. After 3 month, switching to vildagliptin.
Glimepiride
Vildagliptin
Vildagliptin
Starting with vildagliptin. After 3 month, switching to Glimepiride.
Glimepiride
Vildagliptin
Interventions
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Glimepiride
Vildagliptin
Eligibility Criteria
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Inclusion Criteria
* with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open.
* who have never been prescribed with test drugs, sulfonylurea or DPP-4 inhibitor/GLP-1 analogue in 3 months
* who can be applied with CGMS
Exclusion Criteria
* who has any kind of diseases, operations, medical treatments that can affect glucose levels
20 Years
75 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Hye Seung Jung
Assistant professor
Principal Investigators
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Hye Seung Jung, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CGMS_SU_Gliptin
Identifier Type: -
Identifier Source: org_study_id