Effect of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on Glucose Variability and Oxidative Stress
The Comparative Study of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on the Effect of Improving Glucose Variability and Oxidative Stress in Type 2 Diabetic Patients With Inadequate Glycemic Control on Metformin
1 other identifier
interventional
36
1 country
1
Brief Summary
This research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes
Started Jun 2008
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, 2008
CompletedFirst Submitted
Initial submission to the registry
June 16, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedOctober 29, 2009
October 1, 2009
2 years
June 16, 2008
October 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose variability
1 month
Secondary Outcomes (1)
oxidative stress markers (oxidized LDL, N-carboxymethyl-lysine(CML), nitrotyrosine, 8-iso-prostaglandinF2α, 8-OhDG)
1 month
Study Arms (2)
1
EXPERIMENTALSitagliptin
2
ACTIVE COMPARATORGlimepiride
Interventions
Eligibility Criteria
You may qualify if:
- patients with type 2 diabetes
- duration of diabetes less than 10 years
- HbA1c 6.5-8.0%
- BMI 20-30
- on stable dose of metformin (more than 1000mg) for at least 2 months
You may not qualify if:
- having oral hypoglycemic agents other than metformin
- using insulin
- serum creatinin \>= 1.5 mg/dL
- SGOT, SGPT \>= 90
- ischemic heart disease
- congestive heart failure (NYHA class \>=2)
- severe diabetic complication (PDR, CRF, CVA)
- on medication affecting glucose profile (such as steroid)
- infectious disease
- malignancy
- pregnant or breast-feeding woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Catholic University of Korealead
- MSD Korea Ltd.collaborator
Study Sites (1)
Kangnam St. Mary's hospital
Seoul, 137-701, South Korea
Related Publications (2)
Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. doi: 10.1001/jama.295.14.1681.
PMID: 16609090BACKGROUNDColette C, Monnier L. Acute glucose fluctuations and chronic sustained hyperglycemia as risk factors for cardiovascular diseases in patients with type 2 diabetes. Horm Metab Res. 2007 Sep;39(9):683-6. doi: 10.1055/s-2007-985157.
PMID: 17846977BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kun-Ho Yoon, M.D., Ph.D.
Kangnam St.Mary's hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 16, 2008
First Posted
June 17, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 29, 2009
Record last verified: 2009-10