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
Sponsor:
Collaborator:
MSD Korea Ltd.
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00699322
First received: June 16, 2008
Last updated: October 28, 2009
Last verified: October 2009
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014