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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00699322

Enrollment

Registered

2008-06-17

Start date

2008-06-30

Completion date

2010-06-30

Last updated

2009-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

glucose variability, oxidative stress, sitagliptin, glimepiride

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.

Interventions

DRUGSitagliptin

100mg P.O. per day for 1month

DRUGGlimepiride

2mg P.O. per day for 1 month

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Glucose variability	1 month

Secondary

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

Countries

South Korea

Contacts

Primary ContactKun-Ho Yoon, M.D., Ph.D.

yoonk@catholic.ac.kr82-2-590-1402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026