The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects - Full Text View

Purpose

Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin has been shown to have fewer side effects in the control of blood glucose values.

Obesity and diabetes are states of increased inflammation and can influence the free radicals and inflammatory markers (chemicals in the blood which increase due to inflammation in the body) and are also major risk factors for atherosclerotic disease. In this study we want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an anti-inflammatory effect in the human. The purpose of this study is to determine if the addition of sitagliptin to diabetic patients will provide added benefit. We believe that sitagliptin provides these added benefits by suppressing free radicals (charged substances that cause damage to the body) and inflammation.

Intervention

Drug: Januvia (Sitagliptin) 100 mg
Drug: Placebo

MedlinePlus related topics:

Diabetes Obesity Stress

ChemIDplus related topics:

Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects

Further study details as provided by Kaleida Health:

Primary Outcome Measures:

To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases reactive oxygen species (ROS) generation by MNC, protein and mRNA expression of p47phox subunit of NADPH oxidase, in MNC's of obese type 2 diabetic patients [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate that therapy with sitagliptin orally daily (100 mg) for 12 weeks decreases oxidized lipids (9-hydroxyoctadecadienoicacid (9-HODE) and 13-HODE) in plasma and F2-isoprostane in urine of obese type 2 diabetic patients [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Januvia 100mg: Active Comparator The first group will be started on 100 mg sitagliptin daily for 12 weeks	Drug: Januvia (Sitagliptin) 100 mg The first group will be started on 100 mg sitagliptin daily for 12 weeks
placebo: Placebo Comparator will be placed on a placebo for 12 weeks.	Drug: Placebo will be placed on a placebo for 12 weeks.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females with age 20-75 years inclusive.
Type 2 diabetes
Males and Females BMI > 30
Subjects on statins, ACE inhibitors, thiazolidenediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the course of study.
BP under control -No change required to BP medications
HbA1c > 7%

Exclusion Criteria:

Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
Pregnancy
Hepatic disease (abnormal LFT's),Renal impairment (serum creatinine > 1.5),
Participation in any other concurrent clinical trial
Any other life-threatening, non-cardiac disease,
Uncontrolled hypertension (BP > 160/100 mm of Hg)
Congestive Heart Failure
Use of an investigational agent or therapeutic regimen within 30 days of study
Subjects on Exenatide, incretin or insulin therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659711

Contacts


Contact: Barbara Hall, LPN	716-887-5104

Contact: Madeline D'amato, LPN	716-887-5108

Locations


United States, New York
	Diabetes and endocrinology Center of WNY	Recruiting
	Buffalo, New York, United States, 14209
	Diabetes And Endocrinology Center WNY	Recruiting
	Buffalo, New York, United States, 14209

Sponsors and Collaborators

Kaleida Health

Merck

Investigators


Principal Investigator:	Paresh Dandona, MD	Kaleida Health

More Information

Responsible Party:	Kaleida health ( Dr Paresh Dandona )
Study ID Numbers:	1931 Januvia
First Received:	April 10, 2008
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00659711
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Obesity

Stress

Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Kaleida Health Merck
Information provided by:	Kaleida Health
ClinicalTrials.gov Identifier:	NCT00659711