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

Sponsors and Collaborators:	The Catholic University of Korea MSD Korea LTD.
Information provided by:	The Catholic University of Korea
ClinicalTrials.gov Identifier:	NCT00699322

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Sitagliptin Drug: Glimepiride	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose Glimepiride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

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

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:

Glucose variability [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

oxidative stress markers (oxidized LDL, N-carboxymethyl-lysine(CML), nitrotyrosine, 8-iso-prostaglandinF2α, 8-OhDG) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sitagliptin	Drug: Sitagliptin 100mg P.O. per day for 1month
2: Active Comparator Glimepiride	Drug: Glimepiride 2mg P.O. per day for 1 month

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699322

Contacts

Contact: Kun-Ho Yoon, M.D., Ph.D.

82-2-590-1402

yoonk@catholic.ac.kr

Locations

Korea, Republic of
Kangnam St. Mary's hospital
Seoul, Korea, Republic of, 137-701

Sponsors and Collaborators

The Catholic University of Korea

MSD Korea LTD.

Investigators

Principal Investigator:

Kun-Ho Yoon, M.D., Ph.D.

Kangnam St.Mary's hospital

More Information

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.

Responsible Party:	Kangnam St.Mary's hospital ( Kun-Ho Yoon )
Study ID Numbers:	KCMC08MI081
Study First Received:	June 16, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00699322 History of Changes
Health Authority:	South Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:

glucose variability
oxidative stress
sitagliptin
glimepiride

Study placed in the following topic categories:

Metabolic Diseases
Immunologic Factors
Metformin
Diabetes Mellitus
Stress
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents
Protease Inhibitors

Sitagliptin
Glimepiride
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Immunosuppressive Agents
Pharmacologic Actions

Protease Inhibitors
Sitagliptin
Glimepiride
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009