The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes
1 other identifier
interventional
34
1 country
1
Brief Summary
The effect of vildagliptin based treatment versus sulfonylurea based treatment on glycemic variability, oxidative stress, and endothelial function in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 type-2-diabetes-mellitus
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedSeptember 18, 2018
September 1, 2018
1.9 years
June 22, 2010
September 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean amplitude of glycemic excursion(MAGE) for 12 weeks(12weeks - 0 week).
To compare the effect of vildagliptin based treatment for 12 weeks on glycemic variability with sulfonylurea using continuous glucose monitoring system(CGMS).
0 week and 12 weeks
Secondary Outcomes (1)
Change from baseline in oxidative stress markers and inflammatory markers at 12 weeks. Change from baseline in endothelial cell function at 12 weeks.
0 week and 12 weeks
Study Arms (2)
Vildagliptin + Metformin
EXPERIMENTALAdding Vildagliptin to metformin users
Glimepiride + Metformin
ACTIVE COMPARATORAdding Glimepiride to metformin users
Interventions
Adding Vildagliptin 50 mg bid to patients with type 2 diabetes mellitus being treated with metformin 500-1000mg bid per day who had hemoglobin A1c of 7.0-10.0%
Adding Glimepiride 2mg to patients with type 2 diabetes mellitus being treated with metformin 500-1000mg bid per day who had hemoglobin A1c of 7.0-10.0%
Eligibility Criteria
You may qualify if:
- Type 2 diabetic patients with hemoglobin A1c levels within the range 7% - 10%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Novartiscollaborator
Study Sites (1)
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710, South Korea
Related Publications (1)
Kim G, Oh S, Jin SM, Hur KY, Kim JH, Lee MK. The efficacy and safety of adding either vildagliptin or glimepiride to ongoing metformin therapy in patients with type 2 diabetes mellitus. Expert Opin Pharmacother. 2017 Aug;18(12):1179-1186. doi: 10.1080/14656566.2017.1353080. Epub 2017 Jul 17.
PMID: 28714741DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moon-Kyu Lee
Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2010
First Posted
July 28, 2011
Study Start
June 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 18, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share