Clinical trial NCT00699322: Effect of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on Glucose Variability and Oxidative Stress
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: glucose variability
oxidative stress
sitagliptin
glimepiride
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: MSD Korea Ltd.
First posted: 2008-06-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Glucose variability
timeFrame: 1 month
Secondary outcomes:
measure: oxidative stress markers (oxidized LDL, N-carboxymethyl-lysine(CML), nitrotyrosine, 8-iso-prostaglandinF2α, 8-OhDG)
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam St. Mary's hospital
Study officials:
affiliation: Kangnam St.Mary's hospital
name: Kun-Ho Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1055/s-2007-985157.