Effect of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylu... | NCT00699322

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

NCT00699322

Sponsor

The Catholic University of Korea

Status

Unknown status

Last Update Posted

Oct 29, 2009Estimated

Enrollment

36Estimated

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Sitagliptin
Glimepiride

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jun 2010Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Jun 16, 2008

First Submission Date that Met QC Criteria

Jun 16, 2008

First Posted Date

Jun 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2009

Last Update Posted Date

Oct 29, 2009Estimated

Name	Class
MSD Korea Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Sitagliptin	Drug: Sitagliptin
2	Active Comparator	Glimepiride	Drug: Glimepiride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin	Drug	100mg P.O. per day for 1month	1	Januvia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose variability		1 month

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kun-Ho Yoon, M.D., Ph.D.	Contact	82-2-590-1402		yoonk@catholic.ac.kr

Overall Officials

Name	Affiliation	Role
Kun-Ho Yoon, M.D., Ph.D.	Kangnam St.Mary's hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangnam St. Mary's hospital	Recruiting	Seoul		137-701	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16609090	Background	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.
17846977	Background	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.

Type	Date	Date Unknown
Release	Dec 11, 2011
Reset	Jan 13, 2012
Release	Aug 2, 2012
Reset	Sep 4, 2012
Release	Feb 17, 2013
Reset	Mar 20, 2013
Release	Jul 25, 2014
Reset	Aug 13, 2014
Release	Sep 8, 2014
Reset	Sep 12, 2014

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 11, 2011			Jan 13, 2012
Aug 2, 2012

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000068900	Sitagliptin Phosphate
C057619	glimepiride

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds