- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00699322
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 Contact
- Name: Kun-Ho Yoon, M.D., Ph.D.
- Phone Number: 82-2-590-1402
- Email: yoonk@catholic.ac.kr
Study Locations
-
-
-
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
|
100mg P.O. per day for 1month
Other Names:
|
Active Comparator: 2
Glimepiride
|
2mg P.O. per day for 1 month
Other Names:
|
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
Collaborators
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
- 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. doi: 10.1001/jama.295.14.1681.
- 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. doi: 10.1055/s-2007-985157.
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
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
- Glimepiride
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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