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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Sitagliptin
  • 100mg P.O. per day for 1month
• Drug: Glimepiride
  • 2mg P.O. per day for 1 month

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Sitagliptin
• Active Comparator: 2
  • Glimepiride

Primary Measures

• Glucose variability
  • Time Frame: 1 month
    Safety Issue?: No

Secondary Measures

• oxidative stress markers (oxidized LDL, N-carboxymethyl-lysine(CML), nitrotyrosine, 8-iso-prostaglandinF2α, 8-OhDG)
  • Time Frame: 1 month
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The Catholic University of Korea

Overall Clinical Trial Officials and Contacts

Kun-Ho Yoon, M.D., Ph.D. Principal Investigator Kangnam St.Mary's hospital  

Overall Contact: Kun-Ho Yoon, M.D., Ph.D. 82-2-590-1402 yoonk@catholic.ac.kr

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699322

Study ID Number: KCMC08MI081

ClinicalTrials.gov Identifier: NCT00699322

Health Authority: South Korea: Institutional Review Board