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

October 28, 2009 updated by: The Catholic University of Korea

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • Recruiting
        • KangNam St. Mary's Hospital
        • Sub-Investigator:
          • Seung-Hwan Lee, M.D.
        • Sub-Investigator:
          • Eun-Sook Kim, M.D.
        • Principal Investigator:
          • Kun-Ho Yoon, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Sitagliptin
Drug: Sitagliptin
100mg P.O. per day for 1month
Other Names:
  • Januvia
Active Comparator: 2
Glimepiride
Drug: Glimepiride
2mg P.O. per day for 1 month
Other Names:
  • Glimel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose variability
Time Frame: 1 month
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Collaborators

MSD Korea Ltd.

Investigators

  • Principal Investigator: Kun-Ho Yoon, M.D., Ph.D., Kangnam St.Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Estimate)

October 29, 2009

Last Update Submitted That Met QC Criteria

October 28, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCMC08MI081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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