Effect of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on Glucose Variability and Oxidative Stress
Information source: The Catholic University of Korea
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Sitagliptin (Drug); Glimepiride (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: The Catholic University of Korea Official(s) and/or principal investigator(s):
Kun-Ho Yoon, M.D., Ph.D., Principal Investigator, Affiliation: Kangnam St.Mary's hospital
Overall contact:
Kun-Ho Yoon, M.D., Ph.D., Phone: 82-2-590-1402, Email: yoonk@catholic.ac.kr
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
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Glucose variability
Secondary outcome: oxidative stress markers (oxidized LDL, N-carboxymethyl-lysine(CML), nitrotyrosine, 8-iso-prostaglandinF2α, 8-OhDG)
Detailed description:
Sitagliptin might improve not only the mean glycemic control during study period but also 24
hour glycemic fluctuation by restoring the physiologic pattern of insulin secretion.
Furthermore decrease postprandial glycemic excursion should decrease the oxidative stress
markers. Those effects might be amplified in Asian patients because of prominent early phase
insulin secretory defects accompanied with relatively less degree of insulin resistance.
Based on this assumption, 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Kun-Ho Yoon, M.D., Ph.D., Phone: 82-2-590-1402, Email: yoonk@catholic.ac.kr
Kangnam St. Mary's hospital, Seoul 137-701, Korea, Republic of
Additional Information
Related publications: 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. Colette 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. Review.
Starting date: June 2008
Ending date: June 2009
Last updated: June 16, 2008
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