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

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ClinicalTrials.gov Identifier: NCT00699322
Recruitment Status : Unknown
Verified October 2009 by The Catholic University of Korea.
Recruitment status was:  Recruiting
First Posted : June 17, 2008
Last Update Posted : October 29, 2009
Sponsor:
Collaborator:
MSD Korea Ltd.
Information provided by:
The Catholic University of Korea

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin Drug: Glimepiride Phase 4

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  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Glucose variability [ Time Frame: 1 month ]

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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Kun-Ho Yoon, Kangnam St.Mary's hospital
ClinicalTrials.gov Identifier: NCT00699322     History of Changes
Other Study ID Numbers: KCMC08MI081
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: October 2009

Keywords provided by The Catholic University of Korea:
glucose variability
oxidative stress
sitagliptin
glimepiride

Additional relevant MeSH terms:
Glimepiride
Sitagliptin Phosphate
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors