Effect of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on Glucose Variability and Oxidative Stress

Phase 4

• Conditions: Type 2 Diabetes
• Interventions: Drug: Sitagliptin; Drug: Glimepiride

• Registration Number: NCT00699322
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-28
• Last Update Posted: 2009-10-29
• Primary Completion: 2010-06
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sitagliptin	Sitagliptin
2	Glimepiride	Glimepiride

Primary Outcome Measures

Name	Time	Method
Glucose variability	1 month

Secondary Outcome Measures

Name	Time	Method
oxidative stress markers (oxidized LDL, N-carboxymethyl-lysine(CML), nitrotyrosine, 8-iso-prostaglandinF2α, 8-OhDG)	1 month

Trial Locations

Locations (1)

Kangnam St. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of