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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by The Catholic University of Korea. Recruitment status was Recruiting

First Received on June 16, 2008. Last Updated on October 28, 2009 History of Changes

Sponsor:	The Catholic University of Korea
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Dextrose Glimepiride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

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 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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

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	Recruiting
Seoul, Korea, Republic of, 137-701
Sub-Investigator: Seung-Hwan Lee, M.D.
Sub-Investigator: Eun-Sook Kim, M.D.
Principal Investigator: Kun-Ho Yoon, M.D., Ph.D.

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:	Kun-Ho Yoon, Kangnam St.Mary's hospital
ClinicalTrials.gov Identifier:	NCT00699322 History of Changes
Other Study ID Numbers:	KCMC08MI081
Study First Received:	June 16, 2008
Last Updated:	October 28, 2009
Health Authority:	South Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:

glucose variability
oxidative stress
sitagliptin
glimepiride

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012